Summary of EUS-BD approaches reported in Iwashita et al. [44].
\r\n\t
",isbn:"978-1-83968-460-9",printIsbn:"978-1-83968-459-3",pdfIsbn:"978-1-83969-232-1",doi:null,price:0,priceEur:0,priceUsd:0,slug:null,numberOfPages:0,isOpenForSubmission:!0,hash:"babca2dea1c80719111734cc57a21a4c",bookSignature:"Dr. Amin Talei",publishedDate:null,coverURL:"https://cdn.intechopen.com/books/images_new/10404.jpg",keywords:"Water Budget, Ground Measurement, Satellite Data, Empirical Models, Physical Models, Data-Driven Models, Artificial Neural Network, Neuro-Fuzzy Systems, Genetic Programming, Irrigation Management, Drought, Aquifer Management",numberOfDownloads:null,numberOfWosCitations:0,numberOfCrossrefCitations:null,numberOfDimensionsCitations:null,numberOfTotalCitations:null,isAvailableForWebshopOrdering:!0,dateEndFirstStepPublish:"October 29th 2020",dateEndSecondStepPublish:"November 26th 2020",dateEndThirdStepPublish:"January 25th 2021",dateEndFourthStepPublish:"April 15th 2021",dateEndFifthStepPublish:"June 14th 2021",remainingDaysToSecondStep:"2 months",secondStepPassed:!0,currentStepOfPublishingProcess:3,editedByType:null,kuFlag:!1,biosketch:"A pioneering researcher in developing hydrological models using adaptive neuro-fuzzy systems, a pioneering researcher in tropical biofiltration systems, appointed head of the Civil Engineering Discipline in Monash University Malaysia.",coeditorOneBiosketch:null,coeditorTwoBiosketch:null,coeditorThreeBiosketch:null,coeditorFourBiosketch:null,coeditorFiveBiosketch:null,editors:[{id:"335732",title:"Dr.",name:"Amin",middleName:null,surname:"Talei",slug:"amin-talei",fullName:"Amin Talei",profilePictureURL:"https://mts.intechopen.com/storage/users/335732/images/system/335732.jpg",biography:"Associate Professor Amin Talei joined Monash University Malaysia in January 2013 and currently is the head of Civil Engineering discipline. His previous appointment was as researcher in School of Civil & Environmental Engineering of Nanyang Technological University of Singapore where he studied for his PhD during 2008-2011. His research is predominantly focused on hydrological modeling and flood forecasting using artificial intelligence techniques. Most recently, he has been also involved in research projects dealing with sustainable urban water management. To date, he has published over 50 articles in reputable journals and international conference proceedings. He has supervised several PhD and Master students and won the Supervisor of the Year Award in Monash University Malaysia in 2017. 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Venkateswarlu",coverURL:"https://cdn.intechopen.com/books/images_new/371.jpg",editedByType:"Edited by",editors:[{id:"58592",title:"Dr.",name:"Arun",surname:"Shanker",slug:"arun-shanker",fullName:"Arun Shanker"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"878",title:"Phytochemicals",subtitle:"A Global Perspective of Their Role in Nutrition and Health",isOpenForSubmission:!1,hash:"ec77671f63975ef2d16192897deb6835",slug:"phytochemicals-a-global-perspective-of-their-role-in-nutrition-and-health",bookSignature:"Venketeshwer Rao",coverURL:"https://cdn.intechopen.com/books/images_new/878.jpg",editedByType:"Edited by",editors:[{id:"82663",title:"Dr.",name:"Venketeshwer",surname:"Rao",slug:"venketeshwer-rao",fullName:"Venketeshwer Rao"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"4816",title:"Face Recognition",subtitle:null,isOpenForSubmission:!1,hash:"146063b5359146b7718ea86bad47c8eb",slug:"face_recognition",bookSignature:"Kresimir Delac and Mislav Grgic",coverURL:"https://cdn.intechopen.com/books/images_new/4816.jpg",editedByType:"Edited by",editors:[{id:"528",title:"Dr.",name:"Kresimir",surname:"Delac",slug:"kresimir-delac",fullName:"Kresimir Delac"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}}]},chapter:{item:{type:"chapter",id:"60662",title:"Endoscopic Ultrasound in Pancreatic Cancer",doi:"10.5772/intechopen.75211",slug:"endoscopic-ultrasound-in-pancreatic-cancer",body:'\nEndoscopic ultrasonography (EUS) refers to the use of an ultrasound probe on a flexible endoscope to provide ultrasound images from within the GI tract and has applications for use in transoesophageal echocardiography (TOE), endobronchial ultrasound (EBUS), trans-rectal ultrasound-guided (TRUS) prostate biopsies, and evaluation of suspicious lesions in the upper GI tract, including the stomach and pancreas, as well as local lymph nodes. This chapter focuses on the utility of EUS in the assessment of pancreatic lesions. EUS is performed by experienced endoscopists and provides information regarding the sonographic characteristics of lesions of interest, as well as provides opportunity, through instrument channels in the endoscope, to take biopsies and perform minimally-invasive procedures for therapeutic or palliative benefit.
\nEUS has a vital role in the diagnosis, staging, and provision of local therapeutics in the management of PC. Emerging applications and future directions of EUS in PC are also discussed.
\nEndoscopy in its modern form began in 1806 with the invention of the Lichleiter, or ‘light conductor’, by Philipp Bozzini. This device consisted of two parts: the light container and viewing device, and the mechanical part (various speculae) that facilitated access to the subject’s body. The fibre-optic endoscope was originally invented by the then medical student, Heinrich Lamm in 1930 [1]. Poor image quality limited the utility of this endoscope until scientific advances made by Harold Hopkins and Narinder Singh Kapany in 1954 [2] were adapted by Dr. Basil Hirschowitz to create the flexible fiberscope [3].
\nUltrasound as an investigational modality was also being developed at this time, with Neurologist Dr. Karl Dussik publishing the first use of diagnostic ultrasound in 1941 [4]. The addition of radial ultrasound technology to endoscopy is credited to Dr. DiMagno in 1980, who felt that by internalising the ultrasound probe, problems with interfering gas patterns and nearby organs could be avoided, and the accuracy of ultrasound would be improved [4]. Although the intent at the time was to use this technique to image the pancreas, the coupling of endoscopy and ultrasonography also led to the development of transoesophageal echocardiography, endoscopic bronchial ultrasound, and trans-rectal ultrasound.
\nIn 1991, Dr. Peter Vilmann and Søren Hancke utilised the curved linear array endoscope to facilitate minimally-invasive diagnostic and therapeutic interventions during endoscopic ultrasound [5]. The use of the linear array ultrasound probe enabled the use of instrument channels. These channels have facilitated the current utility of endoscopic ultrasound to perform fine needle aspirations (EUS-FNA) for diagnostic purposes, and for minimally-invasive therapeutic alternatives to radiologically-guided, or surgical drainage of collections, for biliary drainage (EUS-BD), and to perform celiac plexus neurolysis (EUS-CPN) [6, 7].
\nEarly PC is often detected incidentally, with identification of a non-specific pancreatic lesion. The gold-standard treatment of early PC is with pancreaticoduodenectomy (‘Whipple’s’ procedure); a major surgical undertaking with significant morbidity. Ensuring an accurate diagnosis of malignancy is crucial to preventing unnecessary surgeries and the complications thereof.
\nDiagnosing early PC noninvasively has been historically a difficult undertaking. Clinical suspicion of PC is often based on either non-specific clinical features (asthenia, weight loss, abdominal pain, anorexia, etc.), or features that are associated with advanced disease (jaundice, hepatomegaly, abdominal distension, signs of pancreatic insufficiency, etc.), but specific to pancreatic malignancy. Contributory evidence of malignancy has historically involved clinical history, including presence of risk factors for PC (discussed previously), serum level of cancer antigen 19-9 (CA19-9), and radiographical appearance on transabdominal ultrasound (US), computed tomography (CT), or magnetic resonance imaging (MRI). The advent of EUS and EUS-FNA has allowed for more accurate radiographical assessment of pancreatic lesions, as well as direct sampling to allow histological assessment of the lesion.
\nCA19-9 is a useful biomarker for monitoring response to treatment, or disease progression or recurrence in patients with an established histological diagnosis of PC [8]. However, the specificity of CA19-9 (68–92%) and positive-predictive value (0.9% for serum concentrations >37 units/mL) negates the utility of CA19-9 in the diagnosis of PC [9].
\nUS can be used to assess pancreatic masses ≥3 cm in size with up to 95% sensitivity [10]. Specificity of US is reported between 94 and 98%, however sensitivity decreases substantially when assessing smaller lesions, and is highly operator-dependent [11]. In order to improve detection of PCs at a size where curative resection is achievable, more sensitive investigations are necessary.
\nAbdominal CT scan (multidetector CT, MDCT) has a sensitivity nearing 100% for pancreatic lesions >2 cm, which reduces to 77% for tumours ≤2 cm [12]. Its utility in assessing local extension is demonstrated by an accuracy for predicting surgical resectability of 80–90% [13], however is limited by its ability to detect liver metastases and early lymph node metastases [11].
\nPercutaneous, image-guided pancreatic mass biopsies using ultrasound or CT, are safe and effective at obtaining the diagnosis of PC. Due to the direct sampling nature of the procedure, specificity is close to 100%, with varying sensitivity between 80 and 90% [14]. Theoretic concerns with regards to percutaneous biopsies include the risk of tumour seeding along the biopsy tract, or the increased risk of peritoneal carcinomatosis in patients having undergone percutaneous biopsy, and is contraindicated in potentially-resectable cases [15].
\nEUS-guided fine-needle aspiration (EUS-FNA) uses the instrument channel of the endoscopy to pass a biopsy needle in front of the linear-array ultrasound probe to obtain tissue from lesions under direct ultrasound visualisation. The angle of the needle can be modified to target more cellular-appearing aspects of the target lesion. Two to 10 passes are made into the lesion with the needle and the use of an on-site cytopathologist, or specialist nurse trained in assessment of samples for cellularity is recommended. EUS-FNA allows for tissue acquisition for diagnostic purposes with a low rate of morbidity and mortality, and allows for early genetic and molecular analysis for research and therapeutic decisions [16].
\nEloubeidi et al. conducted a review of 100 patients who underwent EUS-FNA, and found 95% sensitivity, 95% specificity, 100% positive predictive value, and 85.2% negative predictive value [17]. These results have been replicated and shown to hold in multiple studies, including a meta-analysis and systematic review by Puli et al., who identified 41 studies of EUS-FNA and found a pooled sensitivity of determining the correct nature of pancreatic masses of 86.8% (95% CI 85.5–87.9), a specificity of 95.8% (95% CI 94.6–96.7), a positive likelihood ratio of 15.2 (95% CI 8.5–27.3), and a negative likelihood ratio of 0.17 (95% CI 0.13–0.21) [18].
\nChen et al. conducted a systematic review to determine the accuracy of EUS-FNA. They identified 15 studies, totalling 1860 patients and found 92% sensitivity (95% CI 91–93%, p < 0.001, I2 = 69.6%), 96% specificity (95% CI 93–98%, p = 0.006, I2 = 54.9%) [19]. From a practical point of view, the additional benefit of EUS in the assessment of pancreatic lesions is that radiological characterisation of the lesion, local extension and nodal involvement, and histological sampling can all occur in the one procedure, as opposed to US assessment followed by a separate imaging-guided biopsy.
\nHowever, a more recent Cochrane review highlighted the lack of quality studies in the area of comparative diagnostics with regards to PC; conclusions were unable to be drawn from the data as only three articles were identified that met the pre-defined quality parameters [20]. There is a paucity of good-quality head-to-head prospective, randomised controlled trials that compare the investigative modalities and heterogeneity in the inclusion criteria of many of the current studies within the literature. Coupled with variability in access and quality of EUS-FNA, interpreting the comparative efficacy and developing a standardised pathway for the investigation of pancreatic lesions remains open to debate.
\nHorwhat et al. reported an interesting randomised crossover trial comparing EUS-FNA with percutaneous biopsy. Patients with non-diagnostic first-line investigations were allowed to cross over to be investigated with the alternate modality. Fewer patients who received up-front EUS-FNA went on to have percutaneous biopsy (8/36 (22%) versus 16/36 (44%)). The comparative sensitivity of percutaneous biopsy and EUS-FNA was 62% (95% CI 0.41–0.80) and 84% (95% CI 0.64–0.95), respectively (p = 0.1164) [21]. In such a lethal disease, in a population where clinical deterioration often happens suddenly, accuracy in diagnosis is vital to facilitating early treatment. This study lends support to EUS-FNA over percutaneous biopsy for obtaining an early and accurate diagnosis.
\nOkasha et al. conducted a multicentre, prospective, controlled trial in a non-randomised population of EUS-FNA versus ultrasound-guided percutaneous biopsy (US-FNA) in the investigation of pancreatic head tumours. The investigative modality was dictated by accessibility and feasibility. One hundred and ninety seven patients underwent investigation and comparable accuracy (88.9% for EUS-FNA; 87.2% for US-FNA), sensitivity (84% EUS-FNA; 85.5% US-FNA), specificity (100% EUS-FNA; 90.4% US-FNA), positive predictive value (100% EUS-FNA; 94.7% US-FNA), and negative predictive value (73.3% EUS-FNA; 76% US-FNA) were found. Complications occurred in 1/72 patients (1.38%) in the EUS-FNA group (abdominal pain secondary to pancreatitis), compared with 7/125 (5.6%) in the US-FNA group (three cases of severe post-procedure epigastric pain, three cases of peritoneal seeding, and one case of pancreatic abscess requiring surgical debridement and drainage) [22].
\nIt is important to recognise that peritoneal seeding after EUS-FNA has been reported [23], and is therefore not a delineating factor between choosing between percutaneous and EUS-guided biopsy. Of the 15 cases of needle tract seeding reported in this review of case studies of needle-tract seeding after EUS biopsy, 11 occurred during evaluation of pancreatic adenocarcinoma, with 1 case each of intraductal papillary mucinous neoplasia (IPMN), gastric cancer, malignant melanoma, and squamous cell cancer of unknown origin. All cases of needle tract seeding with relation to investigation of PC occurred with a transgastric approach and did not appear to be related to needle size (mostly 22G) or number of passes (range 1–5).
\nEUS-FNA of solid masses is generally a safe procedure, with a reported overall complication rate of 0.5–2.54% [24, 25]. Complications include infection, bleeding, and acute pancreatitis. The mortality rate of the procedure has been quoted at 0.04% [25]. Several studies have not found significant benefit in diagnostic yield or complication rate relative to needle size used [26, 27, 28]. The use of core (trucut) biopsy (EUS-TCB) instead of, or in combination with FNA has not been investigated to an extent to definitively support its use [29]. EUS-TCB has the potential to provide information about tissue architecture, as well as allow for retrieval of a larger volume of tissue, which in an era of expanding availability of histological and molecular analyses, may become a more desirable methodology, however more information regarding the comparative efficacy and safety is required.
\nFigures 1 and 2 below show the abdominal CT scan and EUS images of two patients referred to our institution for investigation of painless jaundice and a pancreatic mass. The red arrows in the CT images indicate the pancreatic lesion; the red arrows in the ultrasound image indicted the EUS-FNA needle within the pancreatic mass. In the first case (Figure 1), the CT scan and US findings were suspicious for autoimmune pancreatitis. The patient was commenced on high-dose steroids and the lesion resolved and liver function tests returned to normal. In the second case (Figure 2) the EUS FNA confirmed the clinical and radiological suspicion of pancreatic cancer.
\nCT and corresponding EUS image of a pancreatic mass that proved to be autoimmune pancreatitis.
CT and corresponding EUS image of a pancreatic mass that proved to be pancreatic cancer.
Surgery is currently the only possibility for cure in PC. 15–20% of PC cases at time of diagnosis are eligible for resection. For those who undergo a successful surgical resection, the morbidity of the procedure is significant, and the 5-year survival rate (5YSR) remains low at 10–25% [30]. Surgery is indicated in the treatment of localised, or minimally-locally-advanced (Stages I-II) PC. Better cure rates are found with node-negative disease (5YSR ~30%); approximately 10% of patients who undergo complete (R0) resection with limited nodal disease progress to long-term survival [31].
\nThe role of preoperative staging is to accurately assess the above features to guide the surgeon as to the likelihood of obtaining an R0 resection. This can be thought of in terms of assessing the extent of local invasion, as well as the presence of distal disease. Standard abdominal CT scanning is the investigation of-choice for assessing distant disease, but has a low sensitivity for assessing local invasion and peritoneal spread. In one study, 61% of cases deemed resectable by CT assessment were found to be unresectable at laparotomy [32]. This modality should not be used alone in assessing appropriateness for surgical intervention.
\nStandard abdominal CT scans are performed around 60–120 s after injection of intravenous contrast. The optimal timing for imaging of contrast within the pancreas is around 35 s. By using a pancreatic protocol CT, where images are captured at this time point, and then during the washout phase, both local configuration of pancreatic lesions and evidence of local hepatic metastases are elucidated. Pancreatic-protocol CTs are considered the standard imaging investigation for local staging of pancreatic cancer.
\nThe accurate appraisal of the extent of local spread is crucial not only for identifying unresectable disease, but for avoiding false hope and subjecting a patient to an ‘open-and-close’ laparotomy for no therapeutic benefit.
\nLocal surgical expertise often determines the definition of resectable disease on a pragmatic level, however the National Comprehensive Cancer Network (NCCN) guidelines [33] refer to the following factors when determining resectability:
Relation to the superior mesenteric artery (SMA), celiac axis, superior mesenteric vein (SMV), and inferior vena cava (IVC)
Unreconstructable SMV or portal vein
Aortic involvement
Distant metastases
Presence of disease in lymph nodes beyond the field of resection
EUS provides high-resolution images of the primary mass, its relationship to local structures, and the appearance of regional lymph nodes. Conversely to CT, although EUS can detect some liver metastases, it provides insufficient information on distant disease. There have been few studies directly comparing the two modalities, however the combination of both modalities for their relative strengths seems to be the way forward. One study has shown an equivalent PPV of surgical resectability with regards to T-staging of either modality (63%), with a significant increase to 86% when used in combination [34]. While most studies have shown equivalence of EUS and CT with regards to N-staging, EUS has shown greater accuracy in assessing mesenteric vessel involvement, which often has a significant impact on determining surgical resectability [35].
\nEUS has previously been thought to be superior to CT scanning for the detection and assessment of smaller pancreatic lesions, however comment has been made that the technological advances in radiology continually improving the resolution of CT images that contemporary CT scans may show more accurate results. EUS has however, been shown to lead to less overstaging than multidetector CT (MDCT) and MRI [35]. This is crucial so that resectable cases are not appreciated as unresectable.
\nThe use of EUS in screening patients at increased risk (high-risk individuals [HRIs]) has been suggested due to the lethality of the disease, and the often late-onset of clinical features leading to a very low rate of patients diagnosed at a sufficiently-early stage to undergo curative-intent treatment (15–20%) [30]. In line with the Wilson and Jungner criteria for screening, PC is an important health problem with an acceptable treatment, with a ‘latent’ phase wherein curative treatment can be undertaken. EUS is a suitable test for early-stage disease that would be likely acceptable to an at-risk population. The questions remain as to whether EUS is yet an accessible test from a resource-availability perspective, and accurately defining HRIs to whom screening could be offered. Subsequent to this, EUS screening of HRIs is yet to be proven to be efficacious, let alone cost-effective to offer as a screening tool.
\nIdentifying HRIs should be based on risk factors for PC. Risk factors such as family history, presence of germline mutations (BRCA1, ATM, PALB2, CDKN2A, and MLH1), Peutz-Jeghers syndrome (PJS), cystic fibrosis, race, ABO blood group, chronic pancreatitis, diabetes mellitus, smoking history, and obesity, are all factors that could be combined to develop a pancreatic risk score. Wang et al. have developed PancPRO, a predictive model for PC using Bayesian modelling to provide risk stratification for developing PC based on family history. It was validated prospectively using the National Familial Pancreas Tumour Registry with an observed to predicted PC ratio of 0.83 (95% CI 0.52–1.20) [36]. The combination of risk stratification algorithms that may include presence of germline mutations may prove to be a more accurate way of identifying HRIs – more research is needed in this area to more-accurately define an at-risk population in which a screening population can be shown to be efficacious and cost effective.
\nThe use of EUS in HRIs has been explored in a review by Bhutani et al. [37]. They identified 10 studies utilising screening EUS in families with identified familial PC, PJS, familial atypical multiple mole melanoma syndrome, and several other mutations incurring increased risk. A total of 512 screening EUSs were performed across the 10 studies. The rate of abnormal EUS results (pancreatic duct dilatation or ectasia, observable solid or cystic masses, or parenchymal changes) in this study population was 212/512 (41%). Clinical outcome measures (rate of curative resection for detected cases, overall survival (OS), etc.) were not reported overall. Several studies have demonstrated the ability of EUS in HRI to identify pancreatic dysplasia and IPMN, with no reported false-positives when these cases with abnormal EUS progressed to surgical resection [38, 39].
\nThe largest of these studies was performed in 216 individuals with one of the following risk factors:
Relatives with known familial PC and two affected first-degree relatives (n = 195)
Individuals with PJS (n = 2), or
Known familial breast-ovarian cancer patients with at least one first-degree relative affected by PC (n = 19).
Screening was performed on all of these cases with MRI, CT, and EUS. Ninety-two (42%) of participants had an abnormal EUS (at least one pancreatic mass [cystic n = 84, solid n = 3], or pancreatic duct dilatation [n = 5]). Eighty-two of the abnormal EUS cases were IPMNs, and three were neuroendocrine tumours. Five participants went on to have surgical resection, returning three cases of pancreatic dysplasia in <3 cm IPMNs, multiple intraepithelial neoplasms. No cases were identified by CT or MRI that were undetected by EUS. This study lends support to the potential for pancreatic screening in HRIs and supports the choice of EUS as the screening modality over CT and EUS. Further investigation to properly define the characteristics of the at-risk sub-population is needed. The optimal timing and frequency of screening also requires further exploration. The potential merits of screening will need to be balanced against the resource-cost, access, and scalability considerations before routine EUS screening can be supported.
\nThe first reported use of EUS-guided celiac plexus neurolysis (EUS-CPN) was published by Wiersema in 1996. EUS-CPN was performed on 30 patients with celiac plexus neuropathy; 25 with PC, and 5 with other intraabdominal malignancies. This single-arm study demonstrated efficacy in a mild to moderate reduction in pain scores at 2, 4, 8, and 12 weeks post-procedure (1–10 pain scale 6.1 +/− 3.1 versus 4.8 +/− 2.0, p = 0.004) [40]. Complications were minor and transient (diarrhoea in four patients).
\nAlthough no randomised clinical trial has been performed to compare the relative efficacy and safety of CPN via percutaneous versus endoscopic approach, a Cochrane Review of 102 studies concluded that CPN by any modality was associated with reduced pain at 4 weeks (mean difference in visual analogue scale (VAS) −0.42, 95% CI −0.70 to −0.13, p = 0.004). This less than one point improvement of VAS score begs the question of whether this is clinically-significant; coupling this data with quality of life would perhaps be more informative. This improvement was maintained at 8 weeks overall, the review noted significant heterogeneity of results at 8 weeks at this time point. Collective data on opioid consumption in these studies also showed a significant benefit in the CPN group [41]. A retrospective cohort study by Kambhampati et al. compared outcomes of patients who underwent either percutaneous or EUS-CPN between 2008 and 2015 at Johns Hopkins University School of Medicine. This study suggested a non-statistically significant reduction in procedural complications for EUS-CPN (7% EUS vs. 11% percutaneous, p = 0.51), as well as a non-significant higher immediate response rate in percutaneous CPN (87% versus 72% in EUS-CPN, p = 0.08). Response was defined as a decrease in numeric pain score by ≥3 points. There was no significant difference in quality of life measures, opiate usage, or pain response at 1 month between groups [42].
\nAn interesting study of note by Wyse et al. looked at early EUS-CPN at the time of diagnosis by EUS of unresectable disease [43]. Patients with pain and suspected PC underwent a diagnostic and staging EUS. If diagnosis of unresectable adenocarcinoma was made, patients were randomised to either early EUS-CPN or conventional pain management. The early EUS-CPN group was found to have non-significant improvements in pain response (measured by the Likert scale) and morphine consumption at 3 months compared to standard analgesia (pain response −28.9 [95% CI −67.0 to 2.8], p = 0.09, morphine consumption −49.5 [95% CI −127.5 to 7.0], p = 0.10). Although not statistically significant, these data do suggest that early EUS-CPN at the time of diagnosis could be considered to assist with the often difficult-to-manage analgesic requirements in late-stage PC.
\nEUS-guided biliary duct drainage (EUS-BD) can be performed via several methods, but all involve the direct visualisation via EUS of the pre-obstructed biliary tract and puncture of the pre-obstructive system and confirmation with cholangiography. A guidewire is then inserted and the tract is dilated to create a fistula. These techniques rely on accurate EUS images to target the pancreatic duct, common bile duct, or intrahepatic bile ducts (IHBDs) to create a pancreaticogastrostomy, choledocoduodenostomy, or hepaticogastrostomy, respectively.
\nEUS-BD can be performed using several techniques:
Transluminally, where the bile duct or common bile duct is accessed via the stomach or duodenum, respectively.
Rendezvous, where the ampulla is accessed and the biliary duct is targeted with EUS to fistulise a guidewire to facilitate secondary endoscopic retrograde cholangiopancreatography (ERCP) and stenting over the guidewire
Antegrade, where an IHBD is accessed from the upper intestine to bypass the anatomic biliary system altogether.
These techniques allow for bypass drainage of bile around the level of obstruction and have been shown to be efficacious with a low rate of serious complications. Iwashita et al. [44] conducted a literature review of EUS-BD and stenting. Results are summarised in Table 1.
\nSummary of EUS-BD approaches reported in Iwashita et al. [44].
EUS-CDS, EUS-choledochoduodenostomy; EUS-HGS, EUS-hepaticogastrostomy; EUS-RV, EUS-rendezvous.
Complications of EUS-BD were generally limited to peritonitis, pneumoperitoneum, abdominal pain, and perforation. No deaths or need for surgery were reported to have been required for complications arising from EUS-CDS or EUS-HGS. Two deaths were recorded in the 217 cases of EUS-RV; one of these was due to cirrhosis, the other was related to sepsis [44]. No comment on prophylactic antibiotic use was made in this review.
\nA more recent systematic review by Wang et al. of 1192 patients across 42 studies showed similar success rates, with an overall complication rate of 23.3%. The complications encountered were bleeding (4.0%), bile leakage (4.0%), pneumoperitoneum (3.0%), stent migration (2.7%), cholangitis (2.4%), abdominal pain (1.5%), and peritonitis (1.3%), with no differences in complication rate between transduodenal and transgastric approaches [45]. Grade of complications was not reported. It is important to recognise that EUS-BD has historically been utilised in the setting of failed ERCP for biliary drainage and that this may introduce some selection bias towards more difficult cases, or those who have had recent ERCP, which may be attributable to some of the complications documented in the follow-up period of the studies included in these reviews. A randomised controlled multicentre trial (BILPAL) is currently recruiting to compare EUS-BD with standard ERCP in the first-line setting for palliation of malignant obstructive jaundice [46].
\nThe use of EUS as a delivery system for anticancer therapies is an attractive prospect. The poor vascularity and desmoplastic stroma displayed within a malignant pancreatic tumour is likely a significant factor contributing to the relatively poor efficacy of haematogenously-administered systemic therapies. EUS may circumvent this limitation by offering locally administered anticancer therapies directly into the tumour.
\nEUS-fine needle injection (EUS-FNI) has the potential to improve the delivery of active cytotoxic agents such as chemotherapy or viral therapy to the target cancer more effectively, whilst reducing systemic exposure and toxicity. Encouraging early phase data of several investigative approaches are emerging, although larger and randomised studies are lacking.
\nThe use of EUS-FNI of ethanol was investigated in 19 patients with unresectable PC by Yang et al. (2009). At follow-up (between 2 and 7 months), a > 70% reduction in size of pancreatic lesions was identified in 12/19 patients (63%), and a 50–70% reduction in size was found in a further 6/19 patients (32%). Seven patients survived beyond 24 months. No major complications were encountered [47].
\nLevy et al. (2017) performed a prospective study on first-line EUS-FNI with gemcitabine in 36 patients with stage II-IV PCs. Conventional therapies were allowed in all cases at the discretion of the treating Oncologist, but not described in the results. 95 mg (2.5 mL of 38 mg/mL) of gemcitabine was administered via EUS-FNI. OS at 6- and 12-months was 78 and 44%, respectively. Four (20%) patients with stage III disease who underwent EUS-FNI were down-staged and were able to undergo R0 resection [48].
\nImmunogenic approaches have included EUS-FNI of allogenic mixed lymphocytic culture, immature dendritic cells, tumour necrosis factor alpha (TNF-ɑ), and gene-deleted replication-selective viruses such as ONYX-015. These agents are still under investigation and have been shown to be feasible and safe, however early clinical data has not been overwhelmingly positive [49].
\nBrachytherapy induces cell death through the delivery of short-wave beta radiation-emitting particles being placed within the tumour. The local delivery allows for a larger total dose to be delivered to the tumour when compared to external beam radiotherapy (EBRT), with relative sparing of surrounding tissue. Endoscopic brachytherapy (EUS-BT) is being investigated in the management of PC, particularly in locally-advanced unresectable PC, currently treated with either combined chemoradiotherapy with EBRT or palliative chemotherapy alone. Although, the efficacy of EUS-BT has not yet been established, trials in this area including at our institution are ongoing. Figure 3 below shows the placement of brachytherapy seeds under direction visualisation into an unresectable pancreatic cancer through EUS. Figure 4 shows a Bremm study taken 1 week after implantation of brachytherapy seeds showing the radiation field created by the implanted seed. Figures 5 and 6 taken from the same patient shows the radiological response achieved by this technique in this case. More investigation is required to optimise patient selection and delivery techniques.
\nBrachytherapy seed implantation under direct EUS visualisation.
Bremm study one week after brachytherapy.
CT and PET scan of pancreatic cancer pre-brachytherapy implantation.
CT and PET scan of pancreatic cancer post-brachytherapy.
Sun et al. utilised EUS-BT in 15 patients with stage III (n = 8), and stage IV (n = 7) pancreatic adenocarcinoma [50]. 27% of cases experienced a partial response, with a mean duration of response of 4.5 months. Rate of disease control was notable at 80% (partial 27%, mild 20%, stable 33%), and 30% of patients showed a clinical benefit (defined by an improvement in Karnofsky Performance Score and pain response to treatment), particularly with regards to pain reduction. Local complications occurred in three patients (pancreatitis and pseudocyst formation), and grade III haematologic toxicity was encountered in three patients without clinical impact [50].
\nBrachytherapy with several radiation-emitting sources has been trialled (Ra226, Rn222, Au198, Ir192) with significant complications and post-treatment mortality. More recently, I125 has been investigated, with much improved mortality rates, but showed no benefit to cancer-related mortality [51]. Current phase III studies are under way with P32; phase II safety studies have shown a moderate increase rate of serious adverse events per patient when used with 5-fluorouracil (5FU) chemotherapy followed by gemcitabine, compared to EBRT with 5FU chemotherapy, followed by gemcitabine [52]. The varying complication rates reported across studies may also be due to interoperator variability or the low numbers of cases treated. More studies with larger numbers are needed and are currently underway.
\nThere are also some efforts to improve the planning and delivery of brachytherapy to the intended area. Sun et al. (2017) developed a computer-based treatment planning system that was studied in 42 patients with unresectable PC. In this study, EUS-BT using this software was performed and showed an OS for stage III patients of >12 months with an overall median survival time of 9.0 months (95% CI 7.6–10.4 months) [53]. Interestingly, the use of this treatment planning system resulted in no serious adverse events in the study population, which has been a significant criticism of this treatment modality previously.
\nRadiofrequency ablation (RFA) induces coagulative necrosis through the application of heat induced by a medium-frequency alternating current [54]. RFA as an anticancer technique is currently utilised in the management of several other malignancies (hepatocellular, renal, etc.), but is also employed in the disruption of aberrant electrical pathways in the heart, as well as in pain medicine, for the ablation of nerve in certain conditions. Until EUS, the utility of external application of RFA has been limited by the sensitivity of pancreatic tissue and nearby gastrointestinal tissues to RFA, leading to significant complications.
\nEUS-radiofrequency ablation (EUS-RFA) has been studied in several small case series. There have been two recent systematic reviews published on EUS-RFA in pancreatic malignancies [55, 56]. Rustagi and Chhoda (2017) reported on four clinical studies performed in locally-advanced, unresectable adenocarcinoma, pNETs, and pancreatic cystic neoplasms (PCNs). The endpoint of most of the reported studies was complication rate, rather than efficacy or survival. The follow-up period for the articles addressing better-prognosis pancreatic lesions (PCNs / pNETs) was also likely too short to draw conclusions from. Of the 37 cases included across the four studies, adverse events included mild abdominal pain in seven cases, minor duodenal bleeding in one case, jaundice in two cases, duodenal structuring in one case, and cystic fluid collection in one case. The authors concluded that EUS-RFA is feasible and safe in the management of pancreatic lesions, and that more studies are needed with larger sample sizes and longer follow-up periods to investigate EUS-RFA as a treatment modality for PC [56].
\nA high-intensity focused ultrasound (HIFU) transducer has been developed for use with endoscopy. HIFU induces cell death by thermogenic coagulative necrosis, similar to RFA, but by emitting ultrasound waves, rather than radiofrequency waves. Tong et al. (2015) have successfully used this probe to induce lesions in normal porcine pancreatic models in vivo [57] to show proof of concept in inducing targeted areas of cell necrosis in pancreatic tissue. HIFU’s use in inducing cell death in malignant pancreatic lesions has yet to be elucidated.
\nEUS images can be digitised for analysis by artificial neural networks (ANNs) to quantitatively analyse EUS images as to their likelihood of there being a malignant lesion within them. The use of ANN analysis in pancreatic EUS image analysis was reported by Norton (2016). In a study of 21 patients with PC and 14 patients with focal pancreatitis, ANN analysis was able to differentiate between PC and focal pancreatitis with an accuracy of 89%. This was similar to the endosonographer’s impression at time of EUS (accuracy 85%) [58].
\nSaftoiu et al. performed a similar study among 68 patients; 22 with a normal pancreas, 11 with chronic pancreatitis, 32 with pancreatic adenocarcinoma, and 3 with pancreatic neuroendocrine tumours (pNETs). Reported sensitivity, specificity and accuracy were 91.4, 87.9, and 89.7% respectively and the study concluded that larger, prospective randomised controlled trials were needed to further investigate the use of this adjunct diagnostic tool [59].
\nWith constant improvements in image quality, and further development of ANN models, this may prove a useful adjunct to EUS-based diagnosis, particularly if used by inexperienced endosonographers, and may help to broaden the accessibility of this imaging modality.
\nThe act of vibrating tissues and measuring the elasticity of their resultant movement is being used in analysis of pancreatic lesions. In general, firmer lesions tend to be malignant; soft lesions are more likely benign. By qualitatively or quantitatively assessing their rebound potential, inferences can be made on the composition of pancreatic lesions.
\nDue to the differing relative consistency of benign and malignant lesions, quantitative strain elastography results can assist in differentiating subtypes of pancreatic mass. The use of EUS-Elastography has been assessed to have excellent sensitivity (95–99%) for differentiating benign from malignant lesions, however due to the fibrotic nature of many of the benign pancreatic lesions (tumour-forming pancreatitis, and benign pancreatitis with fibrosis), specificity is inadequate (67–76%) to replace direct tissue sampling by way of EUS-FNA [60]. Moreover, there are currently several guidelines on the strain ratio cut-off value for differentiation between tissue subtypes, thus harmonisation and standardisation are required between techniques.
\nElastography can be measured by either strain elastography by measuring propagated external pressure in the axis of the direction of the applied force, or by shear wave elastography [61]. The latter utilises acoustic radiation force impulses to generate perpendicular ‘shear’ waves, the velocity of which can be measured in the field of the ultrasound, and are not affected by structures posterior to the target organ in question. Currently, only strain elastography is available via endoscopic approach. Due to the pulsations of the nearby aorta, the future use of shear wave elastography may be advantageous over current strain elastography.
\nContrast-enhanced harmonic endoscopic ultrasound (CEH-EUS) uses intravenously administered hyperechoic microparticles at the time of ultrasound to provide further information regarding the vascularity of the lesion in-question. In the presence of contrast, PC generally appears hypoenhanced and heterogenous, pancreatitis appears isoenhanced, and pNETs cancers appear hyperenhanced [62]. Sensitivity has been reported to be above 90% in multiple studies [63, 64]. However, as some PCs have been reported as being isoenhanced, the specificity of this modality (68%) is also insufficient for replacing EUS-FNA.
\nCEH-EUS has been combined with EUS-FNA to improve the accuracy of diagnosis of EUS-FNA. Due to the highly desmoplastic stroma in and around PCs, targeting hypoechoic or isoechoic appearance on CEH-EUS for FNA has been shown to improve diagnostic yield when compared to EUS-FNA alone. Sugimoto et al. (2015) have also shown that CEH-EUS-FNA has the potential to reduce the number of needle passes required for diagnosis [65]. In their conclusion, the authors make the valid point that in all reported cases of needle-tract seeding in EUS-FNA, multiple needle passes were performed. Although in need of validation, CEH-EUS-FNA has the potential to reduce the risk of needle-tract seeding by reducing the required needle passes.
\nConfocal laser endomicroscopy (CLE) allows for in vivo histological analysis of tissues in real time. The technique is being developed for the assessment of early pancreatic masses and the surveillance of precancerous lesions. A laser is used to illuminate the target tissue, which is then reflected back through a pinhole to the user. Local or systemic use of fluorescence agents, such as fluorescein can also be used to enhance the image. In endoscopy, CLE can either be done through an integrated endoscope tip, which has been useful for assessing and targeting biopsies of the luminal wall (e.g. oesophagus or stomach), or through needle-based CLE (nCLE), which uses a microfiber that can pass through a 19-gauge needle to assess tissue at the site of the needle tip.
\nnCLE has been studied mostly in investigation of pancreatic cystic lesions and shown to have an accuracy of 46–95% for diagnosing PC, with a low sensitivity 46–59%. Overall complication rate ranges from 0 to 2.5%; complications include bleeding, infection, pancreatitis and perforation [66]. Nakai et al. used a combination of EUS-guided cystoscopy (direct visualisation of the internal wall of a cystic lesion) and nCLE in the assessment of 30 patients with cystic pancreatic lesions. The sensitivity of cystoscopy was 90% for determining PCN vs. BPC, nCLE was 80% sensitive, and the combination of the two modalities was 100% sensitive [67].
\nKongkam et al. conducted a study to validate the CLE diagnostic criteria and found a 90.9% accuracy of EUS-nCLE among 22 patients [68]. They found malignant lesions displayed dark clumping with or without dilated vessels (<40 μm), while benign lesions were more likely to display white fibrous bands and normal acini. They also found good inter-observer agreement between the three blinded endoscopists (κ = 0.82) [68]. These results contrast that of Karstensen JG et al. (2018), who conducted a prospective, dual-centre study on 28 patients with pancreatic masses referred for EUS-FNA and found limited benefit above EUS-FNA alone by using the current proposed nCLE criteria. This study also found significant interobserver and intraobserver analysis of the proposed CLE criteria, suggesting the reproducibility of the procedure is currently suboptimal. They concluded that further development of the technology is needed to permit better delineation between benign and malignant disease [69]. More studies are required in this area before EUS-CLE can be recommended as an adjunct to EUS-FNA for routine analysis of solid pancreatic lesions.
\nThe use of EUS-nCLE to enable direct visualisation of molecular expression with pancreatic cancers has also been explored. Nakai et al. have shown proof-of-concept in the ability to directly image EGFR and survivin expression in porcine models in vivo. This study utilised the direct injection of fluorescein isothiocyanate-labelled antibodies against EGFR and survivin into the pancreas 30 min before EUS-nCLE to highlight the expression of EGFR and survivin, and showed good correlation between the EUS-nCLE images and histological analysis of the porcine pancreas ex vivo [70]. The use of similarly labelled antibodies to KRAS could assist in the stratification of precancerous lesions and direct early-stage treatment.
\nWhat about a section on molecular diagnosis personalised therapy. You cannot tell me that this will not be important in the future. I know self-citation is frowned upon but we have published 3 articles in this space recently?
\nEUS now has an integral and indeed indispensable role in the diagnosis, staging, and treatment of pancreatic cancer and its complications. It is likely that this technique will become increasingly important in the management of patients with this condition.
\nHistory of several bank failures evidences how the excessive risk taking can affect the whole economy as well as the global financial scenario. Since bank deals with different kinds of risks, the regulators strive to minimize this risk exposure through different regulations. The key regulations aiming to minimize the risk and bank failure is the capital adequacy regulation. The principle of the capital adequacy regulation is based on the fact that the minimum capital should be high enough to absorb the potential losses. While capital acts as a buffer for the bank, in the distressed period, the higher the buffer, the lower the risk of default. Therefore, the importance of maintenance of adequate level of capital is never overestimated. This chapter will present a brief history of capital adequacy regulation and the evolution of the regulation over time.
\nBank for International Settlement (BIS), the oldest international financial organization, was founded in 1930. Its members are central banks or the regulatory authorities of 60 countries. The committee aims to serve as a regulatory authority for monetary and financial stability and foster international cooperation.
\nWest Germany’s Herstatt Bank closed its operation on June 26, 1974, due to excessive foreign exchange risk that posed counterparty risk in international settlement with the banks in New York. Subsequently, at the end of 1974 due to this cross-jurisdiction implication, BIS formed “Committee on Banking Regulations and Supervisory Practices” also known as Basel Committee on Banking Supervision (BCBS) headquartered in Basel. Since the inception, the committee has established a series of banking standards to promote monetary and financial stability. Though at the beginning, the group’s members were the governor of Central banks of G10 countries, at present, it has 45 institutions from 28 jurisdictions.
\nBCBS provides assistance to the central banks through regular cooperation to improve the quality of supervision in the banking industry. The committee sets regulations for the central banks. In addition, it acts consistently to enhance the financial stability and level playing field to avoid competitiveness conflicts globally. The member countries implement its prudential regulations and report to the committee periodically. BCBS decisions are expected to be followed by the member countries toward sound practice and standard guidelines in the financial industry [1].
\nThe Committee’s members are Argentina, Australia, Belgium, Brazil, Canada, China, European Union, France, Germany, Hong Kong SAR, India, Indonesia, Italy, Japan, Korea, Luxembourg, Mexico, the Netherlands, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, the United Kingdom, and the United States. BCBS performs as a forum for regular cooperation on banking standard, regulation, and supervision issues between the member countries. It provides comprehensive guidelines for managing bank capital to safeguard against operational and financial risk in an international standard. Toward this standardization in banking operation and supervision, the committee has published a number of landmark guidelines on capital adequacy known as Basel I, Basel II, and Basel III.
\nThis guideline advises holding a minimum amount of capital on the risk-weighted assets of the bank. This regulation is called the capital adequacy regulation (CAR) or minimum capital requirement (MCR).
\nBanks as public confidence institution are strictly guided by regulations and supervision by the regulatory authority. Since risk is an integral part of any financial institution, in the process of providing different services to the economy banks come across different types of risk in their operation. As a result, risk is the subject of all regulation bases [2]. Regulators and risk managers define risk as an uncertainty that has adverse effect on the positive outcome of the bank like banks return, asset, or goodwill. Hence, the regulations intend to enhance the resilience of the bank in the stressed situations to protect the interest of the depositors and other associated counterparts of the bank.
\nIn discussion of bank capital, the most widely used terms that come together are regulatory capital and economic capital. Regulatory capital as its name implies is the minimum level of capital required by the regulatory authority. Principally, the regulatory capital should be derived from the maximization of the social welfare function that takes into account the cost and benefit of the capital regulation [3]. Economic capital is the level of capital chosen by the shareholder of the bank. It relates with a desired rating required to safeguard the bank’s losses at a certain confidence level. So, if the bank’s loss during a period is higher than the initial level of capital, it will be in default. Therefore, the shareholder trades off between the costs of raise or increase of the equity against the benefit of reducing the banks probability of default. Mainly, cost of capital determines the relative position of the economic and regulatory capital. When the cost of capital is low, the economic capital is higher than the level of regulatory capital [3].
\nWhile discussing the economic capital and regulatory capital levels, the actual level of capital or actual capital arises. Actual capital is higher than the regulatory level chosen by the shareholder taking into consideration different regulatory requirements. Threat of closing the undercapitalized bank or avoidance of penalty insists the bank management and shareholders to keep the actual capital level above the minimum requirement.
\nIn this chapter, we will discuss the regulatory capital or the minimum capital requirement (MCR) of the bank.
\nIn 1998, when the world economy faced the economic recession, the Latin American countries could not sustain their debts due to higher interest rates of loans and shorten repayment period [1]. These sovereign defaults possess critical situation for the international banks by eroding the capital buffer and global financial stability. The concern for global financial stability encouraged the BCBS committee to set up an international standard for risk measurement. The committee released a capital measurement system referred to as the “Basel Capital Accord” in July 1988 [4]. The principal of this measurement was to weigh the on-balance sheet and off-balance sheet asset according to the risk they possess. The accord required banks to hold at least 8% of risk-weighted assets (RWA) as capital; 50% of which must be Tier 1 or core capital.
\nInitially Basel Accord I focused to the credit risk of the bank measured by the Cookie ratio. However, being criticized for exaggerating on the credit risk in 1996, an amendment was issued through incorporating the market risk to address banks’ exposure in foreign exchange risk, securities trade, equities, commodities, and options [4]. This amendment permitted the bank to use internal model to measure the market risk and associated capital against this risk.
\nThe first Basel Accord, i.e., Basel I was introduced among the member countries of G-10 which includes Belgium, Canada, France, Germany, Italy, Japan, the Netherlands, Sweden, Switzerland, the United Kingdom, and the United States. The accord was designed to implement among all of the internationally active banks across countries to make a level playing field, i.e., to avoid competitiveness conflicts globally. For large and complex institutions, the regulation becomes less significant. Finally, a more risk-sensitive and comprehensive capital structure guideline—Basel II—was developed.
\nAs a response to Enron scandal and innovation of financial derivatives after the execution of Basel Accord I, a new regulatory framework was imperative to introduce.
\nA more sensitive new capital requirement known as Basel II was initiated shortly in 2004 to accommodate the highly complex on- and off-balance sheet items, promote more risk sensitive capital requirement through banks own assessment, and provide greater transparency. The purpose of the Basel II accord was to address the risk areas that were not covered by Basel I, to measure the capital requirement above the minimum level.
\nThe Basel II accord released in 2004 was developed on three pillars, which are as follows:
Pillar I or minimum capital requirement (MCR)
Pillar II or supervisory review process (SRP)
Pillar III or market discipline (MD)
Pillar I or MCR states that banks are required to maintain regulatory capital that is 8% of risk-weighted assets (RWA). The RWA refer to the total assets of the bank that are risk-adjusted or weighted against credit risk, market risk, and operational risk according to the risk grade. Bank assets consist of cash, investment in securities, loans to governments, and businesses individuals that bear different risk characteristics. Therefore, risk weight is assigned to this asset group to indicate the level of riskiness in each asset group. To calculate the capital requirement, it takes into account both the on-balance sheet and off-balance sheet items of the bank.
\nEligible regulatory capital is constituent of core capital or Tier 1 capital and supplementary capital or Tier 2 capital. Pillar I states the maintenance of regulatory capital on these two types. Core capital is the equity capital of the bank, retained earnings, and other reserves. For supervisory purposes, the committee determined to present the capital of the bank in two groups Tier 1 and Tier 2 where Tier 1 or the core capital should not be less than 50% of the total capital base of the bank that consists of common equity and approved reserves from the retained earnings. Other elements of the capital will have to be grouped in Tier 2 that is limited to 100% of the core capital or Tier 1 capital. Tier 2 includes the following:
Undisclosed reserve or unpublished reserves
Revaluation reserve of certain assets
General provision/general loan-loss reserves
Hybrid debt capital instrument
Subordinated term debt
Short-term subordinated debt covering market risk or Tier 3 capital. Even though the eligible regulatory capital consists of core capital and supplementary capital, to cover the market risk, bank at its discretion can build Tier 3 capital that consists of short-term subordinated debt. This Tier 3 capital base can be built to support solely the market risk and cannot be higher than 250% of the core capital or Tier 1 capital.
\nThe items to be deducted from the capital base are goodwill (deduction from Tier 1 capital), increase in equity due to securitization exposure, and investment in subsidiaries performing in the banking and financial sector that is not included in the national system.
\nMinimum capital requirement (MCR) is calculated for credit risk, market risk, and operational risk. BCBS advises that the minimum capital requirement under Basel II must be 8%, which will be calculated as follows:
\nwhere CAR is the capital adequacy ratio, Tier 1 is the Tier 1 capital, Tier 2 is the Tier 2 capital, Tier 3 is the Tier 3 capital, Cr risk RWA is the risk-weighted asset for credit risk, Oper risk RWA is the risk-weighted asset for operational risk, and Mkt risk RWA is the risk-weighted asset for market risk.
\nThe following sections present a brief discussion on calculation of capital requirements for these risk areas, i.e., credit risk, operational risk, and market risk.
\nRisk-weighted asset for credit risk is calculated for credit RWA for exposure in banking book except the counterparty credit risk arising from equity investment, securitization exposure, and trading book instruments. Bank can choose either standardized approach (SA) or internal ratings-based approach (IRBA) to calculate their capital requirement against credit risk. In standard approach the risk is measured by the support of external rating or credit assessments whereas internal rating based approach is conducted by banks internal rating system and subject to the approval of the supervisors [5].
\nIn case of standardized approach, claims against different counterparties are risk weighted against their rating. This credit rating is assessed by external credit rating institutions. In case of absence of any credit rating, the banks are advised to follow the instruction by the regulatory authorities. National regulatory or supervisory authorities permit the eligibility of the external credit assessment institution upon fulfillment of certain conditions. The credit rating agency must fulfill six criteria: objectivity, independence, international access/transparency, disclosure, resource, and credibility.
\nBCBS advises risk weight for claims on sovereigns, non-central government public sector entities, multilateral development banks, banks, securities firms, corporates, included in the regulatory retail portfolios, secured by residential property, commercial real estate, past due loans, and off-balance sheet items. A higher credit score signifies lower risk weight in calculating the risk-weighted asset of the bank. In standardized approach, bank calculates the total risk-weighted asset of the bank taking into consideration the whole credit portfolio. Along with the regular claims, the unsecured loans that are past due for more than 90 days are also risk weighted. This unsecured portion of the loan is risk weighted after the net of specific provision.
\nIn standardized approach, the off-balance sheet items are converted into credit exposure equivalents through the use of credit conversion factors (CCF). The original maturity time determines the CCF of different commitments in the off-balance sheet items.
\nInternal ratings-based approach (IRB) as its name implies relies on own estimates of risk measurement in determining the capital requirement against credit risk, which are subject to fulfillment of certain conditions as well as disclosure requirements by the regulatory authorities. In IRB, the risk management team identifies the probability of default (PD), loss given default (LGD), the exposure at default (EAD), and effective maturity (M). Through these risk components, banks measure the unexpected loss (UL) and expected loss (EL). The capital requirements are calculated on the basis of unexpected loss. Expected losses are treated separately [5].
\nBCBS defines operational risk as “the risk of loss resulting from inadequate or failed internal processes, people, and systems or from external events.” It includes the legal risk and excludes strategic and reputational risk. The committee advises three measurement approaches to calculate the capital charge against the operational risk of the bank. The approaches are (i) the basic indicator approach (BIA), (ii) standardized approach (SA), and (iii) advanced measurement approach (AMA).
\nBanks are encouraged to follow the sequential order of the measurement approaches. The level of sophisticated risk measurement system and practice would decide to follow the later approaches, i.e., standardized approach and advanced measurement approach. Internationally active banks with significant risk exposure in the operational areas are permitted to follow the standardized or advanced measurement approach.
\nIn basic indicator approach, the capital charge for operational risk is equal to the 15% of average positive annual gross income of the bank. Gross income is the total of net interest income and net non-interest income. It does not include any realized profit or loss from the sale of securities and any income derived from insurance. The calculation of capital charge in basic indicator approach is as follows:
\nHere KBIA is the capital charge in basic indicator approach; GI is the gross income, which was positive, over the previous 3 years; n is the number of previous 3 years for which gross income is positive; and α is 15% required capital level against the operational risk.
\nIn standardized approach, a bank’s activities are divided into eight sectors: corporate finance, trading and sales, retail banking, commercial banking, payment and settlement, agency services, asset management, and retail brokerage. In standardized approach, for every sector separate gross income is calculated separately. To measure the capital charge, this sectoral gross income is multiplied by denoted beta (a factor). Beta is a proxy variable that denotes relationship between the operational risk (of loss) for the particular business sector and aggregate level of gross income for that business sector [5]. Unlike basic indicator approach, standardized approach measures capital charge for each business line separately.
\nIn SA, capital charge is calculated by taking the 3 years average of simple summation of the regulatory capital charge for each of the business sectors. Any negative capital charge due to negative gross income for any business sector may offset the positive capital charge in other business sector without limit. If the aggregate capital charge across all business lines in a certain time period is negative, then the numerator will be considered as zero. BCBS expressed the equation as follows:
\nwhere KSA is the capital charge under the standardized approach; GI1–8 is the annual gross income in a given year, for each of the eight business sectors; and β1–8 is a fixed percentage, set by the BCBS, the level of required capital to the level of the gross income for each of the eight business sectors.
\n\nTable 1 presents the value of β for each business sector as prescribed by BCBS [5] as follows.
\nSl. no. | \nBusiness sector | \nValue of β (%) | \n
---|---|---|
1 | \nCorporate finance | \n18 | \n
2 | \nTrading and sales | \n18 | \n
3 | \nRetail banking | \n12 | \n
4 | \nCommercial banking | \n15 | \n
5 | \nPayment and settlement | \n18 | \n
6 | \nAgency services | \n15 | \n
7 | \nAsset management | \n12 | \n
8 | \nRetail brokerage | \n12 | \n
Value of β for different business sectors.
In advanced measurement approach, banks use some qualitative and quantitative criteria to calculate the risk exposure and capital charge by their own. This approach requires complex modeling and is subject to the approval of the supervisory authority.
\nBCBC defines market risk as “the risk of losses in on- and off-balance sheet positions arising from movements in market prices.” Sources of market risk are interest rate risk, foreign exchange risk, and commodities risk [5]. Interest risk arises from the loss due to movement of interest rate. Foreign exchange risk arises from changes in banks’ assets and liability due to the fluctuation of foreign exchange rate. In the case of cross-border investments, when banks invest in different currencies risk arises due to adverse changes in the exchange rate. Similarly, commodity risk arises from the uncertain future market price changes in commodity prices.
\nMarket risk is measured using the standardized measurement method and value at risk (VaR) or internal model approach. The choice of method is subject to the permission of the regulatory authorities. In standardized measurement method, four risks are addressed which are interest rate, equity position, foreign exchange, and commodities risk. The practice of internal model approach is subject to compliance of certain conditions and approval of the supervisory authorities.
\nTherefore, bank’s total minimum capital requirement will be the summation of the capital requirement against the credit risk, capital charge for operational risk, and capital charge for market risk of the bank.
\nPillar II or supervisory review process intends to assure that the bank has sufficient capital to support different risks arising in the business operation as well as encourage developing and practicing better risk management technique. SRP concedes the bank management to set capital target through developing an Internal Capital Assessment Process (ICAAP) that commensurate with banks own risk profile [5]. It also ensures that the bank management bears the responsibility to maintain the adequate level of capital beyond the minimum level to support its risk. The committee identifies the appropriate relationship between the risk and amount of capital and the effectiveness of bank’s internal control and risk management process. The role of supervisory authority is to evaluate how the operating banks are assessing their risk and capital requirement and intervene if necessary. SRP intends to intervene the bank regulators to prevent capital shortfall from the minimum level in the early stage and to take rapid corrective action [5]. The SRP takes into account other risk factors that are not considered in Pillar I (i.e., liquidity risk and interest risk). The regulatory authority evaluates the bank’s assessment of capital, ability to monitor, and be compliant with the capital regulations.
\nPillar III promotes market discipline through a set of qualitative and quantitative disclosure requirements that allow the market participants to understand the scope of application, capital position, risk exposure, and assessment of the banks. It is complement to Pillars I and II. Therefore, the disclosure allows a bank to present its risk position that is based on a common and consistent framework to the regulatory authority as well as public for comparison and credibility.
\nBank supervisors having their power to disclose requirements to the operating banks contribute to safe and sound banking practices. Banks will have a formal disclosure policy approved by the board of directors, which exhibits the items to be disclosed, frequency, and internal control over the process. These capital and risk disclosure requirements do not conflict with and minimize the scope of the accounting requirements.
\nGlobal economy suffers severe financial distress during 2007–2008. Excess liquidity in the banking sector resulting in too much weak credit or loans to subprime borrowers is at the top of the list behind the crisis of 2007–2008. Other reasons that triggered the global crisis are excessive risk taken by the financial firms, excess leverage, lack of adequate quality capital, inadequate liquidity buffer, and excess dependence on the credit rating agency [6]. The crisis revealed the lapses in the regulatory framework, market transparency, and supervision quality [7]. The crisis of 2007–2008 exposed the shortcomings of Basel II in managing the systematic risk and revealed the moral hazard problem linked with the systematically important banks.
\nIn response to the crisis, BCBS addressing the weaknesses proposed revised capital framework that enforces raising higher quality of capital. It suggests building more common equity to improve loss absorption capacity and maintaining two liquidity standards and leverage ratio. The purpose of the regulation is to increase the level and quality of capital, enhance risk capture, constrain bank leverage, improve bank liquidity, and limit pro-cyclicality. In 2017, the committee reforms Basel III 2010 that seeks the credibility in risk calculation and improvement in comparison on the capital position of the bank [8].
\nThe minimum amount of common equity to be maintained is increased from 2 to 4.5% and capital conservation buffer of 2.5% of the risk-weighted assets of the bank. In addition, the regulatory authority can enforce additional capital buffer during the period of excess credit growth. For systemically important banks, additional loss absorbency capacity can be introduced [7]. In 2017 reform, the committee has brought some changes in calculating credit risk through detailed risk weighing rather than flat risk weight for loans against residential and commercial real estate. In addition, banks are advised to perform due diligence in case of relying on external credit ratings.
\nTo make the banking industry more stable, building capital alone is not sufficient. Therefore, to protect against buildup of excessive balance sheet leverage, Basel III introduced non-risk-based leverage ratio. This non-risk-based leverage ratio is Tier 1 capital to average total restated balance sheet assets over the quarter. The leverage ratio should be minimum 3%.
\nMoreover, for better resilience, (a) liquidity coverage ratio (LCR) for short-term disruption and (b) net stable funding ratio (NSFR) for long-term liquidity mismatch in the balance sheet are introduced. LCR is a standard for a minimum level of liquidity where the institution can generate enough cash outflow from the high-quality liquid assets in any short-term distress situation. The LCR standard is measured by the ratio of stock of high liquid assets to total net cash outflows over the next 30 calendar days. However, NSFR measures the sustainable funding ratio relating to the assets and off-balance sheet activities [9]. NSFR is the ratio of the available amount of stable funding to the required amount of stable funding, which should be greater than 100%. It suggests the banks to rely on long-term liabilities over short-term liabilities and small and retail liabilities over wholesome liabilities in case of short-term maturity (less than 1 year) for better resilience.
\nThe crisis also revealed that the existing regulation has not appropriately covered major on- and off-balance sheet items, trading book, and derivative-related risk exposure. BCBS advises a revised framework to address the trading book exposure under Basel III that increases the capital charges around three to four times of previous level. Basel III upholds the counterparty credit risk management and collateral risk management and addresses the pro-cyclicality effect and credit valuation adjustment risk to reduce the reliance on external credit rating agencies. Table 2 presents the present capital ratio and liquidity ratio advised by the committee [10].
\nParticulars | \nMinimum % of RWA | \n
---|---|
Common equity | \n4.5 | \n
Capital conservation buffer | \n2.5 | \n
Tier 1 capital | \n6 | \n
Total capital | \n8 | \n
Liquidity coverage ratio | \n≥100 | \n
Net stable funding ratio | \n≥100 | \n
Minimum capital requirement ratio.
The case of Lehman Brothers and AIG call attention to how a single firm can boost up shock in the financial market as well as in the global economy. The financial crisis of 2007–2008 has revealed that microprudential guideline alone is not sufficient to address the systematic risk. Macroprudential regulation that takes into account the risk arising from interconnectedness of the financial institutions is important to respond to the systematic risk and financial stability in the economy.
\nTherefore, the macroprudential guidelines impose additional capital requirement for systematically important banks to reduce their default probability. BCBS advises building common equity of 2.5% of risk-weighted asset as capital conservation buffer so that in times of distress, this buffer can be scaled down to absorb losses. BCBS also advises the regulatory authorities to raise an additional countercyclical capital buffer of 2.5% to respond with excessive credit growth that may induce systematic risk in the financial sector. Banks incur a huge loss during downturn followed by a long excessive aggregate credit growth. After the asset price bubbles loans go unpaid, prices go down, banks loan decrease, and level of defaults even increases more [11]. To prevent this systematic risk, banks are advised to build additional capital up to 2.5% during the credit growth time that ensures the sufficient level of capital during the distress periods. It ensures that during the downturn, the banking institution has enough cushions to absorb the additional loss and provisioning. It also intends to support the financial stability by building countercyclical capital buffer during boom period through increasing to the cost of credit which reduces the demand for it [12].
\nBCBS provides capital standard for conventional banks but Islamic banks are also under the same jurisdiction toward a safe and sound banking system. Islamic banks differ from the conventional banks in their operation due to unique items in the liability side of the balance sheet, risk sharing with the depositor and investor, absence of interest, and so on. Moreover, Islamic banks cannot access some credit derivatives to mitigate risk like conventional banks because of governing by the Shariah Principle. Wide range of financing mode also poses Islamic banking to face different kinds of risk. Since the operation of Islamic banking differs from the conventional banking, the determination of capital requirements also differs [13]. Studies find BCBS capital regulation does not address the risk of Islamic bank and lacks the goal to minimize the level of risk faced by the Islamic banks. Furthermore, it contributes to increase the risk of Islamic banks [14].
\nThe Islamic Financial Services Board (IFSB) is an international organization that provides prudential guidelines and standards for the Islamic banks, insurance (takaful), and capital markets to enhance the stability of the Islamic financial industry. IFSB provides the standards aligning with the global regulatory standards in calculating capital requirements, thereby making disclosure toward transparency and market discipline [12]. However, because of asset-based financing, profit-loss sharing, profit bearing, or loss sharing principle, the capital determination is different from the conventional banking institution. Like the BCBS, IFSB also advises countercyclical capital buffer to the Islamic banks to reduce the systematic risk during the period of excessive credit growth.
\nThe relationship between bank capital level and risk management is the most studied issue after the capital regulation regime. The empirical evidence provides useful insights about the factors affecting the risk undertaking of the banks. However, the studies focusing on the relationship between capital, risk management, and performance found contrasting results. Several studies found, in effect, that capital regulation stimulates the banks to take excessive risk through allowing the banks to increase riskier investment with the increase of bank capital [6]. Regulatory restriction, lower rate of return, riskier portfolio, and deposit insurance are the major causes identified behind the positive association between risk and capital regulations [15, 16]. Building capital raises cost of capital, decreases expected profit and rate of return, and induces the bank to invest in riskier sector that is more riskier in the long run [16]. Conversely, strict regulation, income diversity, and bank size are the factors identified behind the negative relationship between capital regulation and bank risk [17, 18, 19, 20]. However, studies also find that capital regulation has different impact on conventional and Islamic banks.
\nBank regulations and supervisions are to make the financial system more resilient that facilitate the stakeholders, creditors, depositors, and different counterparties. It prevents banks to take excessive risk. Therefore, to increase the financial stability around the world, BCBS a committee of BIS provides prudential guidelines for the banks and other financial institutions. The committee has advised three capital accords: Basel I, Basel II, and Basel III. Basel III is addressed to mitigate the regulatory lapses and systematic risk faced by the banks during recent financial crisis of 2007–2008.
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\n\nThird Party Rights: A person who is not a party to this Publication Agreement may not enforce any of its provisions under the Contracts (Rights of Third Parties) Act 1999.
\n\nEntire Agreement: This Publication Agreement constitutes the entire agreement between the parties in relation to its subject matter. It replaces all prior agreements, draft agreements, arrangements, collateral warranties, collateral contracts, statements, assurances, representations and undertakings of any nature made by, or on behalf of, the parties, whether oral or written, in relation to that subject matter. Each party acknowledges that in entering into this Publication Agreement it has not relied upon any oral or written statements, collateral or other warranties, assurances, representations or undertakings which were made by or on behalf of the other party in relation to the subject matter of this Publication Agreement at any time before its signature (known as the "Pre-Contractual Statements"), other than those which are set out in this Publication Agreement. Each party hereby waives all rights and remedies which might otherwise be available to it in relation to such Pre-Contractual Statements. Nothing in this clause shall exclude or restrict the liability of either party arising out of any fraudulent pre-contract misrepresentation or concealment.
\n\nWaiver: No failure or delay by a party to exercise any right or remedy provided under this Publication Agreement or by law shall constitute a waiver of that or any other right or remedy, nor shall it preclude or restrict the further exercise of that or any other right or remedy. No single or partial exercise of such right or remedy shall preclude or restrict the further exercise of that or any other right or remedy.
\n\nVariation: No variation of this Publication Agreement shall have effect unless it is in writing and signed by the parties, or their duly authorized representatives.
\n\nSeverance: If any provision, or part-provision, of this Publication Agreement is, or becomes invalid, illegal or unenforceable, it shall be deemed modified to the minimum extent necessary to make it valid, legal and enforceable. If such modification is not possible, the relevant provision or part-provision shall be deemed deleted. Any modification to, or deletion of, a provision or part-provision under this clause shall not affect the validity and enforceability of the rest of this Publication Agreement.
\n\nNo partnership: Nothing in this Publication Agreement is intended to, or shall be deemed to, establish or create any partnership or joint venture or the relationship of principal and agent or employer and employee between IntechOpen and the Author or any Co-Author, nor authorize any party to make or enter into any commitments for, or on behalf of, any other party.
\n\nGoverning law: This Publication Agreement and any dispute or claim, including non-contractual disputes or claims arising out of, or in connection with it, or its subject matter or formation, shall be governed by and construed in accordance with the law of England and Wales. The parties submit to the exclusive jurisdiction of the English courts to settle any dispute or claim arising out of, or in connection with, this Publication Agreement, including any non-contractual disputes or claims.
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