Pressure devices
\\n\\n
Released this past November, the list is based on data collected from the Web of Science and highlights some of the world’s most influential scientific minds by naming the researchers whose publications over the previous decade have included a high number of Highly Cited Papers placing them among the top 1% most-cited.
\\n\\nWe wish to congratulate all of the researchers named and especially our authors on this amazing accomplishment! We are happy and proud to share in their success!
Note: Edited in March 2021
\\n"}]',published:!0,mainMedia:null},components:[{type:"htmlEditorComponent",content:'IntechOpen is proud to announce that 191 of our authors have made the Clarivate™ Highly Cited Researchers List for 2020, ranking them among the top 1% most-cited.
\n\nThroughout the years, the list has named a total of 261 IntechOpen authors as Highly Cited. Of those researchers, 69 have been featured on the list multiple times.
\n\n\n\nReleased this past November, the list is based on data collected from the Web of Science and highlights some of the world’s most influential scientific minds by naming the researchers whose publications over the previous decade have included a high number of Highly Cited Papers placing them among the top 1% most-cited.
\n\nWe wish to congratulate all of the researchers named and especially our authors on this amazing accomplishment! We are happy and proud to share in their success!
Note: Edited in March 2021
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Today, nonwoven fabrics are the fastest growing area of the textile industry [1, 2]. As nonwoven fabrics are made directly from fibres, bypassing the large number of operations involved in assembling fibres first into yarn and then preparing the yarns suitably for the fabric formation process, tremendously decreases the labour cost, allows easier cutting and sewing for unskilled labour and reduces the lag time during production process [3]. Furthermore, nonwoven allows modifying its properties by selecting different fibres or binders and controlling the arrangement of the fibres in the web. Hence, they are successful in many industrial and medical applications including geotextiles, diapers, wipes, draperies, furniture, mattress, mattress pads, apparel, etc. [4]. Each of these applications has different demands due to which the specific properties and characteristics of the nonwoven must be addressed carefully in order to design optimised fabric structure with maximum benefits. This chapter focuses on a particular end application for the nonwoven as a padding bandage used in multi-layer compression system recommended for chronic venous ulcers.
Nonwoven padding is an essential component in a multi-layer compression system [5, 6]. Padding lies underneath compression bandage or stocking through which substantial amount of pressure is exerted on the limb of patient. Padding plays two major functions: first it helps to maintain uniform pressure around the circumference of limb, and, second, it helps in proper exchange of moisture or air for improved comfort to the patient. This chapter addresses several issues related to padding: it begins by mentioning the medical problem, identifying the product requirements, describing the role of fibre and construction, attempting theoretical modelling to understand padding behaviour, examining the structure–property relationship and finally recommending the optimised product.
Chronic venous disorder occurs due to improper functioning of venous system, especially in the lower extremity, which makes it difficult for the venous reflux to return to the heart from the legs [7, 8]. Patients suffering from such disorders have poor quality of life due to consistent pain, limited mobility, physical function, depression, social isolation and high treatment cost [9]. It has been estimated that 1% of the general population (age group: 18–64) is suffering from chronic venous disorders [10]. This rate is further increased to 4% in people over the age of 65 [11]. Furthermore, it has been anticipated that the rate will increase significantly in future due to changing lifestyle and the growing aging population.
Chronic venous disorders such as varicose veins, deep vein thrombosis, oedema, ulcers, lymphoedema, etc., happen primarily in lower limbs when the veins are not able to pump enough blood back to the heart. This improper functioning is the result of venous hypertension [12]. In most cases, venous hypertension is caused by reflux through incompetent valves, but other causes include venous outflow obstruction and failure of the calf-muscle pump owing to obesity or leg immobility. Deep vein thrombosis is the condition where the blood clots (thrombus) inside the veins, which obstructs the smooth flow of blood toward the heart [13]. The blood trying to pass through these blocked veins can increase the blood pressure in the vein, which, in turn, will overload the valves. This can lead to damage to the valves, which can further worsen the problem as these incompetent values will not be able to prevent backflow of blood. This may result in pooling of blood in the surrounding tissues, which will cause swelling (also termed as oedema). Over time, this can worsen the condition and result in venous ulceration (Figure 1).
Different forms of chronic venous symptoms in lower leg (varicose veins, venous oedema and venous leg ulcers; from left to right)
Compression therapy is the cornerstone of treatment for phlebological and lymphatic conditions [7, 14-17]. The prime objective of compression therapy is to reduce the venous pressure in the affected limb region [13, 17, 18]. This finally serves several functions:
It reduces the venous diameter and increases the interstitial pressure in the surrounding, which increases the blood flow in the deep veins.
It restores the valve function by bringing the walls of the veins closer together.
It reduces blood pressure in the superficial venous system.
It reduces the pressure differences between the capillaries and the tissue to prevent backflow.
It increases the cutaneous microcirculation, favours white cell detachment from the endothelium and prevents further adhesion.
It reintegrates the interstitial liquids into the vessels.
The main parameter responsible for clinical efficiency is the interface pressure [19-26]. Interface pressure is defined as the pressure exerted by the compression system over the surface of skin. The Laplace’s Law is used to predict the interface pressure (
where
Several important factors must be present for a health practitioner to use compression systems, like knowing how to use different products, knowing the best available compression modalities available for the treatment, being able to identify the aetiology of the ulcer, and the willingness of the patient to agree to the commencement of compression treatment and for this to be sustained. Today, there exist several modes of compression devices. Table 1 lists some of the most common devices used for providing pressure. The basic constructions are woven or knitted. Woven construction consists of two sets of perpendicular yarns (also known as warp and weft yarns) that are interlaced together with the help of weaving process. Knitted construction consists of intersecting loops that are produced by a knitting process.
\n\t\t\t\t | \n\t\t\t\n\t\t\t\t | \n\t\t\t\n\t\t\t\t | \n\t\t
\n\t\t\t\t | \n\t\t\t√ Maintained compression √ Pressure can be adjusted √ Recommended for high level of compression (35–80 mmHg) | \n\t\t\t√ Need to be applied by well-trained physicians and nurses √ Pressure variation and no measurement | \n\t\t
\n\t\t\t\t | \n\t\t\t√ No trained physicians required √ Suitable for low pressure (20–40 mmHg) | \n\t\t\t√ Difficult to put in √ Different stocking for different legs | \n\t\t
\n\t\t\t\t | \n\t\t\t√ Augment venous return √ Effective for immobile patients | \n\t\t\t√ Expensive, noisy, bulky √ Requires immobility for a few hours/day | \n\t\t
Pressure devices
Nonwoven is not used for generating compression. But it does play a very important role in compression and comfort management, which is discussed in the next section. Nonwoven is commonly used for the preparation of padding material for the multi-layer compression bandaging system. In a multi-layer compression system, there exist several layers of fabrics in addition to compression layer:
The roles of each of these layers are critical in the successful treatment of venous diseases.
In addition to compression layer, the role of padding is also critical in the successful treatment of chronic venous disorders. A suitable thickness of padding (~1–2.5 cm) is used between the bandage and skin layer for uniform pressure distribution [5, 29]. Padding is wrapped underneath the compression bandage and left over the wounded area for long period of time. In order to distribute pressure evenly around the limb, it is essential that high pressures created at the tibia and fibula regions are absorbed by the padding material. The normal pressure applied by the compression bandage gets absorbed and distributed within the structure of padding bandage. Some amount of pressure is dissipated in the structure, and the rest is transmitted through the thickness of the padding bandage to exert final absolute pressure on the patient’s leg. Padding can also be used to reshape legs which are not narrower at the ankle than the calf. It helps to reshape the limb more like a cone-shape so that the pressure gradient can be achieved with more pressure at the ankle and less at the calf.
In addition to pressure management by padding, the other concern is to maintain good thermo-physiological comfort and to ensure better compliance for the patient during the course of compression treatment [30]. The thermo-physiological comfort concerns the heat and moisture transmission characteristics through clothing, that is, transmission of heat, air and moisture (liquid and vapour) [31, 32]. Multi-layer compression systems, such as 4-layer bandaging, are used for extended periods of time with minimum dressing change. This may cause overheating of the underlying tissues and, perhaps, excessive sweat production due to poor air or moisture exchange between the body and the surrounding [33]. Clearly, the removal of excess fluid or exudates is extremely important to avoid irritation and ensure comfort to the patients. Over-hydration or even maceration of the underlying tissues is likely to happen if the body fluids are not continuously removed from the affected region. Improper management of excessive wound exudates or other body fluids may delay healing and lead to other complications. The padding is used underneath the bandage and therefore is in direct contact with the skin. The interaction of fluids with the padding is therefore critical, as this determines the ability of padding to spread the liquid to a wider area and therefore helps in faster evaporation and prevention of excess moisture build-up. This will also provide better comfort to the patient. Furthermore, the surplus heat produced due to muscular activity should be discharged into the surrounding to facilitate wound healing. Several properties of padding including air permeability, moisture and thermal transmission, wicking, etc., are important here to finally ensure better thermo-physiological comfort of the compression product.
Important physical and physiological factors affecting padding comfort
Other comfort for padding includes the sensorial or tactile comfort which is related to the mechanical contact of the fabric with skin, that is, how a fabric or garment feels when it is worn next to the skin [31]. These are fabric handle or feel, softness, fullness, warm–cool touch, static charge generation, flexing, pricking, itching, etc. The physiological comfort, such as fitting, which is related to aesthetic properties of the fabric, that is, drape, lustre, colour, crease, pilling, staining, etc., are not our concern for the padding application. Figure 2 lists the important physical and physiological factors affecting padding comfort. Among all comfort characteristics, the most important factor is the movement of heat and moisture (liquid and vapour) through padding to maintain the thermal equilibrium between human body and the environment.
Nonwoven used for padding is developed either via needle-punching or thermal-bonding process. Needle-punched technology is where the entanglement of fibres is achieved via mechanical punching using needle beds. In thermal-bonding process, heat is used for the bonding of fibrous web. The fibres used for nonwoven padding is either single-component fibres (polyester, polypropylene, viscose, or cotton) or blend of fibres (polyester/viscose, polyolefin/viscose or polyester/cotton) in the structure [29]. In addition to nonwoven structure, the foam materials are also used as padding. The material used for foam padding is polyurethane and the common structure is open cell foam. Polyurethane foam materials have the advantage of not adhering to the wound or surrounding skin, which makes them attractive when treating fragile skin often found in the elderly [34]. Also these polyurethane materials absorb wound drainage four times more than hydrocolloid dressings of similar sizes. Foam dressings are usually supplied as square pads of different sizes with steep edges. Hybrid structure can also be used as padding [30]. Laminating foams on the woven or knitted structure are being commercially used. Also, the combination of nonwoven and open cell elastic foam is also found where the foam is laminated on the filament-reinforced nonwoven.
Several requirements must be met before considering a nonwoven as an ideal padding bandage. Some of critical needs are [6]:
It should be light weight and easy to handle. Since multi-layer compression system has multiple layers, the overall system seems bulky and heavy to the patient. A light padding will not add too much weight and therefore is recommended for the therapy.
It should be soft and impart cushioning effect to the limb. As the padding is in direct contact with the skin, so a soft padding will provide better sensorial or tactile comfort.
It should be capable of distributing pressure at critical regions especially over bony prominence. This is important to prevent tissue damage.
It should have good fluid absorptions and wicking properties. To tackle excess sweating or exudates, the padding should be able to transport these fluids to wider areas for faster evaporation.
It should not produce irritation or any allergic reaction to the skin on prolonged contact.
It should be cheap and easily available.
It should tear easily by hand. The limb shape or size for different patients is different and therefore there are different requirements for the lengths and thicknesses of padding. Padding with high tearing strength will add more difficulties to nurses or health practitioners during wrapping.
It should not be very stiff and should be easily conformable with the contour of the limb.
The measurement of interface pressure exerted by a compression device is of importance, for both efficacy and tolerability. Several instruments are available that can be used for pressure measurement directly on the leg. Most of them are air-filled devices such as Kikuhime® (Meditrade, Soro, Denmark; Figure 3a), SlGaT-tester® (Ganzoni-Sigvaris, St. Gallen, Switzerland), and Picopress® (Microlab, Padua, Italy) [35]. They are inexpensive, thin, flexible, adjustable and optimised for different applications and different measuring regimes. Picopress® and SlGaT-tester® allow continuous recording during dynamic tests and over longer time periods. Although direct pressure measurement on the limb is more relevant, there exist several limitations of using
Compression load-recovery test is common to obtain the energy absorption ability of a nonwoven material. An Essediel thickness tester was used for measuring compression characteristics of textile materials (Figure 3b). The specimen was placed on a flat surface, and the transverse weight was applied using a pressure foot (20 mm diameter). The compressive pressure was increased from 20 to 200 kPa by applying additional dead weights during the compression cycle, and similarly in recovery the pressure was decreased in steps. The thicknesses were measured at different compressive loads during compression and recovery cycles. The initial thickness
a) A simple prototype for the pressure measurement using Kikuhime® pressure sensor; b) An Essediel thickness tester for compression-recovery test
Thermo-physiological wear comfort and skin sensational wear comfort are two main aspects of wear comfort of any clothing [31]. The first one concerns the heat and moisture transport properties of the fabric, while the latter one deals with the mechanical contact of the fabric with the skin, its softness and pliability in movement and its lack of prickle, irritation and cling when damp. The main properties of the fabric that influences the thermal comfort are: air permeability, water or moisture vapour permeability/transportation and heat transmission [36]. Air permeability is a measure of how well a fabric allows the passage of air through it. It is expressed as the volume of air (in cc) that passes in 1 s through 1 cm2 of fabric under a pressure head of 1 cm of water. Figure 4a shows the photograph of a TEXTEST Air Permeability Tester (FX3300) to measure the air permeability at a standard atmosphere of 98 Pa. Similar to air permeability, the moisture vapour transmission indicates the breathability of the textile to allow water vapour to pass out from the skin surface through the textile. This is expressed as the steady water vapour flow in unit time through unit area of body, normal to specific parallel surfaces, under specific conditions of temperature and humidity at each surface. Figure 4b shows a Moisture Vapour Transmission Tester (Model CS-141), which offers an easy and fast method to obtain the moisture vapour transmission rate. Thermal comfort is related to the fabric’s ability to maintain skin temperature and allow transfer of perspiration produced from the body. For the evaluation of thermal comfort, a very simple instrument Alambeta (Sensora) is available, which can measure thermal characteristics of textile such as thermal resistance, thermal conductivity and thermal absorptivity (Figure 4c).
(a) TEXTEST air permeability tester; b) moisture vapour transmission tester (Model CS-141); c) Alambeta (Sensora) for heat transmission
Apart from the above-mentioned comfort properties, liquid transport behaviour of padding is also critical. This helps in removing body fluids or exudates from the wounded portion to prevent excess moisture build-up that causes irritation or discomfort to the wearer. The measurement of fluid transport is essential to understand how padding behaves on interaction with the fluids and what should be ideal structure for the nonwoven to obtain more spreading of body fluids to promote faster evaporation or removal. Several vertical and in-plane wicking tester are available that can be used for easy assessment [37-41]. Vertical wicking is determined by measuring the wicking height against gravity for a hanging fabric. An in-plane wicking deals with the transport behaviour in the horizontal plane of the fabric and describes several useful parameters such as the liquid flow anisotropy, the rate of movement, and the area of wet surface with time. Figure 5 shows the photograph of the computerized wicking tester for in-plane transport measurement [41].
Photograph of the instrumental set-up for measuring in-plane wicking
The magnitude of final pressure that appears on the surface of skin is more relevant in the compression treatment. Compression bandage applies a total pressure on the surface of padding which causes a pressure loss. This pressure loss is attributed to the significant changes in structure of the padding during compression, which results in its permanent thickness reduction, and significant energy loss. The absorbed energy by the padding during compressive load could be a good indicator of the pressure loss or absorption during the use of padding beneath compression bandage. The thickness change during compression-load-recovery test is used to obtain this energy loss or absorption in the nonwoven structure. The thickness changes in loading can be expressed as [42, 43]:
where
where
where
where
A typical curve of pressure-thickness data for a nonwoven
The lower the value of
where,
where
Liquid transport, that is, wicking, happens due to capillary action that occurs when the fibrous network is completely or partially immersed in a liquid or in contact with a limited amount of liquid from an infinite (unlimited) or limited (finite) reservoir [39]. During transport, the liquid in a nonwoven structure can transmit through the thickness of the sample, that is, transverse wicking, or it can move along the plane of the fabric, that is, longitudinal or in-plane wicking [39, 44-46]. The thickness of padding is small as compared to other dimensions; and therefore, the liquid transmission in the plane of padding is more relevant for the present case. The basic theory in the field of non-homogeneous flows was proposed by Young and Laplace, which is related to the equation of capillarity as [44, 47]:
where ∆
where
a) A tube (
Substituting, Eqs. (11) and (12) in Eq. (10) and expressing the volume
The parameters,
where a and b are constants. When the penetration of liquid is horizontal (β = 90°), the effects of the gravitation field are negligible and the acceleration g vanishes and therefore the second term (
The above equation can be used for our case where the liquid from a point source is poured at the centre of a textile substrate and the spreading occurs radially outward in horizontal plane (Figure 7b).
Although different nonwoven materials such as needle-punch, melt spun, thermal bonded, etc. are used as padding, this chapter focuses more on the needle-punch structures. A needle-punch structure is obtained from the entanglement of fibres which is achieved via mechanical punching using needle beds [3, 4]. The structure is decided by the fibres and the processing parameters, for example, fibre size and distribution, depth of needle penetration, amount of feed, layering factor, and needle punching frequency. As an example, the results of a set of nonwoven samples made from 100% polypropylene fibres are described. The varying parameters are the fibre linear density (expressed as denier ̶ weight of 9000 m length of fibre), mass per square meter (g/m2) and needling density (punches/m2) of the nonwoven. Three levels of fibre denier (2.5, 6 and 15) are taken for comparison. The gram per unit area and needling density (punches/m2) of the nonwoven samples can be obtained by changing the machine parameters. The effect of different levels for the mass per square meter (100, 200, 300 and 400 g/m2) and needling density (50E4, 130E4 and 210E4 punches/m2) is explained on the pressure and comfort performance of padding product.
Energy or pressure absorbed (%) by padding decreases with increase in mass per unit area of padding (Figure 8a). This is due to the fact that the increase in mass per unit area leads to availability of more number of fibres for sharing the compressive load. Availability of more fibres increases entanglement during preparatory methods, and this causes more frictional resistance to prevent fibre-to-fibre slippage during compression load-recovery test. Reduction of fibre slippages minimizes the permanent deformation in compression-load recovery test. Therefore, lower energy absorption is obtained for higher mass per unit area of padding. Furthermore, the amount of energy loss decreases with increasing needling density (Figure 8b). Increase in needling density also stimulates more entanglement of fibres, which causes the compact and stiff structure of padding [42, 43]. This avoids fibre-to-fibre slippages during compression; hence, there will be low energy or pressure absorption for a stiff padding compared to soft padding. In real scenario, the use of a heavy and stiff padding should be avoided as it would not be able to absorb the excess pressure at critical regions. If comparing different fibres, it can be concluded that the energy absorbed is less for padding composed of thinner fibre than coarser fibre (Figure 8c). Thick or coarse fibre has less specific area compared to thin fibre, due to which the frictional resistance within the porous network of padding will be lesser for thick fibre compared to thin fibre. Moreover, padding made from coarser fibre has more porous structure. This all results in more energy absorption and therefore more pressure reduction for the padding made from higher fibre linear density compared to lower fibre linear density.
Effect of structural parameters of nonwoven on pressure absorbency: (a) effect of mass per unit area (50E4 punches/m2; 2.5 denier); (b) effect of needling density (100 g/m2; 2.5 denier); (c) effect of fibre denier (100g/m2; 130E4 punches/m2)
The effect of structural parameters is same on the air permeability and moisture vapour transmission rate (MVTR). Air permeability and MVTR decreases with increasing the level of both mass per unit area and needle density (Figures 9a, 9b, 10a & 10b). This is due to decrease in size of the air-conducting channels during more punching process and also due to availability of more fibres for the entanglement, which decreases the permeability of the air or moisture to the padding. The effect is opposite for the fibre denier where both increase with increase in the fibre denier (Figure 9c & 10c). The density of the padding bandages decreases with increase in fibre denier due to which there is increase in the size of the air channels which provide easy air or moisture flow.
Effect of structural parameters of nonwoven on air permeability: (a) effect of mass per unit area (50E4 punches/m2; 2.5 denier); (b) effect of needling density (100 g/m2; 2.5 denier); (c) effect of fibre denier (100g/m2; 130E4 punches/m2)
Effect of structural parameters of nonwoven on moisture vapour transmission rate (MVTR): (a) effect of mass per unit area (130E4 punches/m2; 6 denier); (b) effect of needling density (300 g/m2; 2.5 denier); (c) effect of fibre denier (300g/m2; 130E4 punches/m2)
For thermal results, the thermal resistance increases with increase in mass per unit area for same level of needling density (Figure 11a). This is because thickness of samples increases with increase in mass per unit area. Also the thermal resistance of padding decreases with increase in needling density (Figure 11b). For the liquid transport (Figure 7b), the spreading time is lower for the samples having more free spaces in the capillary network. Increasing mass per unit area and needling density reduces the porosity, and stimulates lower rate for fluid transport and takes more time (Figure 12a & 12b). Nonwoven made from coarser fibres results in larger capillaries and shows faster spreading rate and takes lower time (Figure 12c).
Effect of structural parameters of nonwoven on thermal resistance: (a) effect of mass per unit area (50E4 punches/m2; 2.5 denier); (b) effect of needling density (100 g/m2; 2.5 denier); (c) effect of fibre denier (100g/m2; 130E4 punches/m2)
Effect of structural parameters of nonwoven on liquid transport (time taken represents the total period taken by liquid to cover an area 380 cm2 of a circular specimen as shown in
Several inferences can be drawn based on the above results of needle-punched padding:
Padding materials should be made as isotropic as possible, for any anisotropy will lead to behaviour variations at different directions, thus causing non-uniform pressure performance and less effective fluid absorption or transmission properties in certain directions.
It is recommended that padding with more porosity and larger pore size could help in better management of liquid exudates, air or moisture exchange. To achieve that the mass per unit area and needling density of the nonwoven has to be decreased which results in more porosity. This will accelerate the evaporation and thereby prevent excess moisture build-up. Moreover, fibres with higher linear density should be selected for the preparation of padding to get bigger pore size that is more suitable for faster spreading.
In general practice, a heavier or thicker padding is recommended in order to obtain maximum pressure reduction especially at critical regions over bony prominences such as tibia or fibula. However, a heavier padding will be more obstructive in liquid flow. So, a balance should be made to get optimum pressure performance with good transport/transmission characteristics.
All the above points should be taken into consideration to design or develop suitable padding structure for maximum performance.
Padding is critical in compression management; it serves several functions including pressure or comfort management. Padding can have different fibrous materials or structure due to which it can have different mechanical responses while it is being used. Understanding of all these parameters is essential to have improved understanding of the role of textile material or structure for the designing or engineering of optimised products. This chapter introduces the structure–property relationship of nonwoven padding. However, there exist several gaps in the literature which should be systematically examined for further improvement. Some future outlooks could be as follows:
All the above description is based on the single padding layer. However, the padding is just one of the parts of the multi-layer compression system. The system has multiple layers of different fabrics once wrapped over the limb. These include cohesive, padding, compression and wound layers. Each of these layers performs a different role or function. The performance of overall assemblies should also be assessed for better judgement.
Padding bandage lies underneath the bandage that applies significant amount of interface pressure in the range from 10 to 50 mmHg to the leg. Under external compression, the porosity or indeed the wicking performance of the padding will change significantly; so it is expected that the liquid transport or other transmission behaviour of the same padding material will vary when exposed to different levels of normal compression. Clearly, the effect of the external pressure has to be accounted for in future analysis. Also the model for fluid transport should be modified accordingly to account for porosity change due to external pressure.
This chapter focuses more on the performance of only needle-punched samples. Study should be conducted for other nonwovens such as thermal-bonded and melt-spun. The performance of other fibres such as PET, cotton, wool and viscose should also be examined.
The patients using compression treatment can have dynamic or static nature. Especially old patients prefer to sit for longer period of time, and the limb is therefore under static state. On the other hand, there may be some group of patients who are still active or working even under compression treatment. Under such circumstances, the limbs can undergo active movement. The assessment of padding should be done for both static and dynamic cases.
Although the present study is based on lab-based measurement, it may be possible to have different results once used on the real leg. More sophisticated approaches are needed to do an
Textiles give us a lot of flexibility in choosing an appropriate structure or weave for a particular application. Although the nonwoven is primarily used in the padding for so long, but there is still possibility to look for other textile structure. The spacer fabric (3D warp knitted structure) could have more potential in compression and comfort outcomes. The comparisons of the nonwoven with other textile structures should also be examined.
Compression system is usually worn for an extended period of time. This chapter only reveals the immediate response of the padding. Further study should be conducted on evaluating the time dependence performance.
This chapter introduces the basics of a medical problem related to venous disorders and related compression modalities. The need and role of different fibrous materials in compression management are presented. More focus is given in describing the critical functions of the padding. Padding is used for the pressure redistribution on the limb. Furthermore, it helps to ensure proper comfort to the wearer due to proper management of heat, moisture, air, liquid, etc. Herein, the nonwoven paddings have been evaluated for the compression and different comfort properties including air permeability, moisture transmission, heat flow and liquid transport. The importance of different nonwovens and their structures are reviewed, which could affect padding performance. Based on the observed results, it has been recommended that padding with more porosity and larger pore size results in more pressure absorption and good transmission (air/moisture/liquid). Padding with low mass per unit area and needling density results in more porosity and therefore can help in faster transport of fluids, air or moisture to a larger area. Moreover, fibres with higher linear density should be selected for the preparation of padding to get bigger pore size, which is more suitable for faster transmission and more pressure absorption. This can further help in deciding the optimum structure or material for an ideal product. Some useful theoretical insights are also provided to relate the structure–property relationship to access different padding performance using model parameters. In conclusion, this chapter could serve as a complete package to readers regarding nonwoven product development and optimization. Some future goals are also listed, demanding more innovative solutions or approaches to overcome the limitations of the existing problems, and exploiting the existing features and capacity of nonwoven padding.
Acute pancreatitis (AP) is the most serious emergent disease in the gastroenterology field. The most common cause of AP is naturally gallstones. The most cases have mild disease and the illness limits itself in a short time period. In 15–20% of cases, the severe form of AP develops. The triage of patients with AP in accordance with the severity of illness is the single most important factor affecting monitorisation and treatment protocol of these patients. Acute biliary pancreatitis (ABP) develops due to gall stones and or sludge mostly coming from gall bladder, impacted in ampulla Vateri (AV) leading to increased pancreatic ductal pressure, pancreatic edema, inflammation and possibly necrosis. A lot of human and animal studies displayed that biliary obstrucition lasting more than 48 hours creates pancreatic necrosis. Therefore, before the endoscopic retrograde cholangiography (ERCP) area, surgery was used to induce biliary decompression and impede progression into pancreatic necrosis, however, new quests started after facing high rate of morbidities and mortalities associated with surgery.
Introduction of ERCP and endoscopic sphincterotomy into the daily practice, endoscopic relieving of biliary obstruction has come into reality. Nevertheless, occurence of complications even mortalitiy in association with ERCP initiated new debate about its indications and timing in patients with ABP. Although for the last 30 years, there has been many ongoing studies about to whom and when ERCP will be perforrmed in ABP, a certain conclusion has not been encountered yet. There has been 2 main strategies on debate [1].
Early routine ERCP strategy: If acute gallstone pancreatitis is triggered by duct obstruction caused by a stone, it would be reasonable to suggest that early ERCP with removal of any residual stones might reduce the severity of pancreatitis. The strategy of early ERCP is strongly supported by results from experimental studies and human studies, which show that the duration of biliary obstruction is a major factor in determining the severity of pancreatitis and that decompression of the biliary system can prevent progression of the disease. In addition, patients with severe pancreatitis tended to have stones impacted in the ampulla, and early (within 48 hours) surgical decompression of the obstruction has been shown to decrease mortalite rates These observations lend support to the theory of using early ERCP to remove obstructing stones in acute gallstone pancreatitis.
Early conservative management with or without delayed or selective use of ERCP strategy: Proponents of early conservative management with selective use of ERCP argue that early routine ERCP may lead to many unnecessary ERCPs in the majority of patients as the offending gallstone has often passed before the diagnosis of pancreatitis is made. Also, it remains unclear whether early ERCP improves the prognosis of acute gallstone pancreatitis. The severity of the pancreatitis may be determined at its inception and may not be dependent on the duration of duct obstruction. Furthermore, performing ERCP in the setting of acute pancreatitis can be technically difficult because of swollen ampulla and duodenal wall. Thus, it may be prudent to identify patients with persistent duct obstruction who would benefit from ERCP after a period of conservative medical management in order to avoid unnecessary negative ERCPs.
Due to 2 different approaches, how an imminent ERCP will affect the existing clinical situation in patients with ABP holds its uncertainity. There has been also no agreement on the preference of an urgent ERCP (U-ERCP) within 24 hours of patients’admission or an emergent ERCP (E-ERCP) within 48–72 hours [2]. These terms; U-ERCP and E-ERCP have been used in recent reports and the first paper published by Neoptolemos and et al. defined U-ERCP and E-ERCP differently than the other papers; the first one within 72 hours and the later within 35 days after admission [3]. Later on, ERCP within first 72 hours was labeled as U-ERCP [4] and after the year of 2000, U-ERCP has been defined as ERCP within 24 hours and E-ERCP as ERCP within 24–72 hours [2]. In severe ABP, there are some risks such as patient’s bad general situation, technical difficulties due to pancreatic edema and potential interruption of aggressive fluid resuscitation during and after the ERCP procedure. Therefore, valid only for patients having persisting indication for biliary decompression, seveal authors and our clinical experience favor E-ERCP together with immense supportive treament of these patients rather than U-ERCP in the absence of life threatining cholangitis.
In severe cases with AP, there can be pain, fever, cholestasis, mental confusion and hypotension due to ongoing pancreatic inflammation and necrosis and under this circumstances, an imminent ERCP can make the situation even worser [5]. Although, if we scrutinize the real life data, we will see that there is some kind of pressure on ERCP physicians to perform ERCP at night and or at weekends by the physicians seeing these patients with ABP in the emergency room [6]. However, in severe ABP, it would be impossible to guarentee the co-existence of cholangitis only by looking at some clinical and biochemical parameters, the use of harmless non-invasive methods such as magnetic resonance cholangiography (MRCP) and or endoscopic ultrasonography (EUS) seems to be more reasonable. Hence, endoscopist who will perform ERCP should estimate the clinical situation of patient with ABP correctly and know very well to whom and when ERCP should be done. Thirty four years after the first report by Neoptolemus [3] suggesting wider application of ERCP with ES during AP, Schepers NJ [4] reported a multicentric article (APEC study) which underlined the fact that U-ERCP with ES does not reduce AP associated complications and mortality compated with conservative approaches. These authors supported a conservative strategy in severe ABP with ERCP indicated only in patients with cholangitis or persistant cholestasis.
In this chapter, we will mention about the role of ERCP during ABP in accordance with the clinical studies and meta-analysis published on this subject and we will add our self clinical experience and practice in this area. The order of titles will be as such,
The pathogenesis and natural history of ABP
The estimation of cholangitis and cholestasis
The treatment steps in the first 72 hours in reference to International Guideliness
To whom and when ERCP should be done during ABP?
In the setting of ABP, biliary stones or sludge material impacted in ampulla vateri induce transient obstruction in the biliary tree and pancreatic ductus, followed by reflux of bile into the pancreatic channel. Consequently, undraining pancreatic channel develops increased ductal pressure leading to backflow of activated pancreatic enzymes into the parenchyma. This starts a cascade of tissue injury with a spectrum of events starting with mild parencymal inflammation ending with loss of pancreatic parenchyma due to severe necrosis [7]. For sure, cholestasis and or cholangitis due to biliary obstruction in addititon to pancreatic inflammation can add into the clinical scenario. There are several evidences indicating the duration of obstruction correlates with te severity of pathology in the pancreas. These evidences reveal that persisting obstruction after 48 hours leads to different degrees of necrosis and if the ductal decompression is obtained before that time period, disease associated morbidity and mortality decreases significiantly [8, 9, 10, 11, 12, 13, 14, 15, 16]. Runzi et al. [8] used an animal model of AP by balloon obstructed biliopancreatic ductal system and they relieved the obstruction at 1th, 3rd and 5th days. The authors documented that the severity of parenchymal inflammation, fat necrosis, hemorrhage, acinar cell vacuolisaiton and necrosis were most prominent in animals with obstructed ductal sysytem at 5 th days of the experiment. On contrary, animals having decompressed ductal sysytem at 1th and 3 rd day of experiment, pancreatic injury was able to be avoided. Another report by Acosta et al. [11] investigating the same subject on a clinical study put forth that severe pancreatitis develops significantly more in patients with the obstruction lasting more than 48 hours compared to those having less than 48 hours of obstruction. These authors suggested to wait for 48 hours to implement an ERCP as the impacted stone may fall down spontaneously and if the signs of obstruction persists after 48 hours, then we should think about ERCP. On the grounds that at least half of the cases, the impacted stone in Ampulla Vateri will fall down spontaneously within 24–48 hours after ampullary and duodenal edema diminishes, we know that the pancreatitis in these patients will limit itself and recover within a few days. Acosta et al. [12] investigated the effects of early ductal decompression in a report and they compared 30 patients who underwent ERCP within first 48 hours with 31 patients who got only conservative treatment. Within the first group, 16 had passed the stone into the duodenum during 48 hours and only 14 patients underwent ERCP in whom 11 were shown to have impacted stones. In the second group of patients, 22 patients had got rid of obstuction spontaneously and 9 patients who had persistent signs of obstruction underwent ERCP and only 3 of them had impacted stone. As a result, %78 of patients passed stones spontaneously into the duodenum and E-ERCP was performed on the others within 48 hours without an uneventful clinical course and mortality. Another report by Cavdar et al. [13] indicated that 74% of patients with ABP passed stones into the duodenum within 72 hours of admission.
Based on all this data and our clinical experience about the natural progression of ABP, we suggest conservative approach during the first 24 to 48 hours to limitate the severity of pancreatitis by agressive fluid recessuation correction hypovolemia and organ hypoperfusion. This approach also allows us to evaluate the patients with regard to the presence of cholestasis and cholangitis and to find out which patients need ductal decompression.
APACHE II, Ranson, Glasgow veya Atlanta criteria are used to evaluate the severity of AP. Cholangitis and or cholestasis are assessed according to the presence or absence of severe pain, mental confusion, hipotansiyon, jaundice, elevated serum bilirubin ve liver enzymes and absence of bile in the aspirated gastric juice. Acosta and et al. [14] clearly demonstrated that absence of bile in the aspirated gastric juice hyperbilirubinemia and severe pain are the parameters most sensitive and spesific for the ongoing obstruction of AV. The authors concluded to apply ERCP to this subgroup of patients. However, these findings may also occur in patients with severe pancreatitis and do not indicate the existence of cholangitis. Thus, ERCP performed based only on these findings may worsen pancreatitis, even end up with death. Therefore, we need better methods to show the stone in the biliary tree. Before the area of MRCP and endoscopic ultrasonography (EUS), we would do diagnostic ERCP and endoscopic sphincterotomy in every patient with a diagnosis of ABP even if we did not detect gall stones in the bile duct. This policy has changed to ‘never do diagnostic ERCP in ABP’ and do first MRCP or if possible more sensitive EUS to decide if ERCP will be done or not.
On clinical practice, the presence of cholangitis and or cholestasis in a patient with ABP is estimated by clinical and biochemical parameters together with abdominal ultrasonography (USG) [15, 16, 17, 18, 19]. Severe abdominal pain, fever, mental confusion, hypotension and jaundice can be seen in severe acute pancreatitis even in the absence of cholangitis. In 20% of patients, the liver enzymes can be persistently normal. The sensitivity of abdominal USG is very low around 27–50% in the diagnosis of cholestasis and cholangitis. The bile duct diameter can persist several days after spontaneously passing stones. Thus, we need more sensitive methods to detect cholangitis and or cholestasis. Nearly 20 years ago, ERCP has been widely used for a diagnostic purpose. However, there have been important developments with the administration of MRCP and EUS into the gastroenterology practice [20, 21, 22, 23, 24, 25, 26, 27, 28, 29]. EUS is better than MRCP to detect gall stones smaller than 5 mm and after detecting the stone by EUS and as an adavantage of this procedure, ERCP can be used to extract the stone from the bile duct at the same session after EUS procedure [21, 22, 23, 24, 25, 26, 27]. Moon and his collagues [28] reported the accuracy rates of USG, computed tomography, MRCP, ERCP and intraductal USG to detect bile duct stones are 20%, 40%, %80%, 90%, 95%, respectively. The authors underlined IDUS and ERCP as the most sensitive methods to detect a CBD stone and suggested to use MRCP to choose the suitable patient for ERCP. They also notified that the rate of agreement between ERCP and MRCP is 90.6% and the large common bile duct has been mentioned as a factor for MRCP to overlook the bile duct stones.
MRCP has a low diagnostic value compared to EUS in a patient with dilated CBD having small sized stones. Scheiman and his colleagues [29] investigated and compared the cost and clinical efficacy of EUS and MRCP done 24 hours before the ERCP procedure. The authors identified EUS as the best cost-effective modality to prevent unnecessary ERCP. Thus, this will protect patients from potential complications of ERCP. Furthermore, 20% of bile duct stones smaller than 8 mm and detected by MRCP were found to pass spontaneously into the duodenum until the time comes for an ERCP procedure. Thus, EUS will reliably help us to give final decision to do ERCP or not. Another advantage of EUS is its applicability on bed side for patients warded in intensive care units. Additionally, in patients with normal gall bladder evaluation on percutaneous USG, EUS can detect sludge in the gall bladder in the setting of ABP. We can also use a quick EUS examination performed within 72 hours of hospitalization to decide if patients can be discharged early from the hospital. This strategy can decrease the health expanses as well. Thus, it seems very rational to increase cost effectivity of caring for ABP patients by provoking the motivation of ERCP physicians to get learn how to do EUS and vice versa [25, 26, 27].
Severe cases with ABP should be hospitalized in spesific centers having MRCP, ERCP and preferably EUS facilities under the control of a team of physicians consisted of gastroenterologist, pancreatobiliary surgeon and invasive radiologist [30, 31, 32, 33, 34, 35]. First, the severity of AP in accordance with the international scoring models must be determined and the patient’s co-morbidities should be recorded. Thereafter, these patients should be vigorously hydrated to prevent the collapse of pancreatic circulation. Indeed, we will especially emphasize aggressive fluid replacement therapy in these patients in the first 3 days of admission with patients with AP. This issue is also very important for the prophylaxis of post-ERCP pancreatitis [36].
A meticiluos fluid replacement within this very 24 hours limits pancreatitis by correcting the hypovolemia and organ hypoperfusion, hinders local and systemic complications of AP by decreasing Systemic Inflammatory Response Syndrome (SIRS) and associated multiorgan failure and lowers inhospital mortality. This helps to improve the general status of the patient and decreases the risks of further invasive procedures like ERCP in these circumstance. During the first 24 hours, iv crystalloid and or colloid solutions can be given [30, 31, 32, 33, 34, 35, 37, 38]. Although a retrospective study depicted no difference between ringer lactate (RL) and normal saline (SF) infusion with regard to the severity and complications of pancreatitis [39], there are vast data from the experimental and clinical studies supporting the benefits of RL; such as RL infusion hampers hyperchloremic acidosis and other metabolic complications of AP and by improvinng intraparenchymal pH status, RL infusion inhibits zymogen activation and worsening of AP [40, 41]. For these reasons, RL has been suggested by many international guidelines as first choice to be used as fluid therapy in these patients with AP [30, 31, 32, 33, 34, 35, 36]. In the absence of heart and kidney failure, RL infusion at 5–10 ml/kg/hour dose within the first 24 hours is recommended to these patients as targeted fluid therapy. By this way, we aim to get normal hemodynamic parameters, urine output 0.5–1 ml/kg/hour and hematocrit value as between 35–44%. However, we need to be scrupulous to avoid hypervolemia in elderly patients during fluid recesutation. Therefore, it is important to limit the dose to 5 to 10 ml/kg/hour as more than 10 ml/kg/hr. infusion rate has been associated with mehcanical ventilation, abdominal compartment syndorme and increased mortality [42].
Before 1978 when Classen [43] first did ERCP and endoscopic sphincterotomy in acute pancreatitis, ERCP was considered as contraindicated in AP. Thereafter, this dogma has changed by Safrany and his collegeus [44] who did ERCP in 15 cases with ABP in 1980. They detected impacted stone at AV in 8 patients and in 7 of them, they showed choledochal stone and removed the stones in all the patients. None of the patients developed any complications and discharged withn a short period after ERCP procedure. After 1980, case series have been reported in this area and first randomized controlled study about this subject was published by Neoptolemos and his collegues in 1986 [3]. In 1993, Fan and et al. [45] published a report in which they investigated the effects of early ERCP on progression of AP. The authors showed that early ERCP was useful only in patients with biliary sepsis compared to conservative group if there is an existing biliary pathology both in mild and severe cases of AP. However, early ERCP did not introduce declined morbidity and mortality when all other etiologies of AP had been included in the study cohort.
Nonetheless, many complications associated with ERCP have been reported in the following years and when and to whom ERCP questions became subject to many researches. ERCP and endoscopic sphincteratomy can make the situation worse in a patient with AP since therapautic ERPC had been reported to have 10% morbidity and 0.1% mortality rates [46, 47]. Additioanlly in patients with AP, there is potential risk of technical failure in ERCP procedure due to edema in the AV and duodenum itself.
For this reason, both the timing of ERCP and detrmining the correct patient who needs this procedure carry the utmost importance. In 2013, International Pancreas Union and American Pancreas Union published together ‘the management guideliness of AP’ and the suggestions about biliary system problems were written as follows [31]:
“ERCP is not indicated in predicted mild biliary pancreatitis without cholangitis. (GRADE 1A, strong agreement). ERCP is probably not indicated in predicted severe biliary pancreatitis without cholangitis (GRADE 1B, strong agreement). ERCP is probably indicated in biliary pancreatitis with common bile duct obstruction (GRADE 1C,strong agreement) ERCP is indicated in patients with biliary pancreatitis and cholangitis (GRADE 1B, strong agreement)
Urgent ERCP (<24 hrs) is required in patients with acute cholangitis. Currently, there is no evidence regarding the optimal timing of ERCP in patients with biliary pancreatitis without cholangitis.(GRADE 2C, strong agreement)
MRCP and EUS may prevent a proportion of ERCPs that would otherwise be performed for suspected common bile duct stones in patients with biliary pancreatitis who do not have cholangitis, without influencing the clinical course. EUS is superior to MRCP in excluding the presence of small (<5 mm) gallstones. MRCP is less invasive, less operator-dependent and probably more widely available than EUS. Therefore, in clinical practice there is no clear superiority for either MRCP or EUS.(GRADE 2C, strong agreement)”
Therefore, we will discuss the subject of bliary tree management in patients with AP as subtitiles; 1-Mild pancreatitis in the absence of cholangitis and persistent cholestasis. 2- Severe pancreatitis in the absence of cholangitis and persistent cholestasis 3- Acute pancreatitis together with the presence of cholangitis and persistent cholestasis. We will also discuss; 4- U-ERCP versus E-ERCP and 5-the role of elective ERCP 3 days after patient’s admission to prevent recurrence of AP.
The first randomized controlled trial in this field is published by Neoptolemus et al. in 1986 [3]. No relationship was found related to pancreatitis complications and mortality between the conservative treatment group and the ERCP group in mild acute biliary pancreatitis patients in this study and in the meta-analysis which contains 4 randomized controlled studies of Sharma et al. [48]. The patients were stratified by the severity of pancreatitis in the study of Burstow et al. [49] but the patients with or without cholangitis were not analyzed separately and eventually, a strong tendency to decrease pancreatitis complications has been suggested in patients with mild acute biliary pancreatitis, although this is not statistically significant (OR 0.67; 95% CI, 0.43, 1.03; P = 0.06). Another meta-analysis of 5 randomized controlled studies including 702 patients, which compared the conservative treatment and E-ERCP in acute biliary pancreatitis patients by Morietti et al. [50] showed no effect on pancreatitis complications (1.8% (95% CI -5.6% to 9.3%); p = 0.6). Since there is no mortality in patients with mild pancreatitis, a comparison could not be made in this regard. Petrov et al. [51] did not demonstrate any statistically significant difference between the E-ERCP group and the conservative treatment group in terms of reducing complications of pancreatitis in neither mild nor severe acute pancreatitis in their meta-analysis of 5 randomized controlled studies including 717 patients. A systematic review by Geenen et al. that published in Pancreatology in 2013 [52] examined the guidelines and meta-analysis in this field till then, reported that U or E-ERCP±ES had no place in mild acute biliary pancreatitis. As we do in our clinical practice, Elective ERCP (EL-ERCP) might be performed before the cholecystectomy only in case, the stuck stones in AV have escaped back into the choledoc and if this is proved by MRCP or EUS.
As a result, there is consensus that U or E-ERCP±ES is not indicated in mild acute biliary pancreatitis without cholangitis [31, 33, 34, 35].
ERCP in acute biliary pancreatitis is still a controversial issue, and there no consensus about it. As mentioned before, clinical and animal studies showed that if the biliary obstruction is not terminated within 48 hours, the pathology progresses to necrosis and then organ failure occurs. Therefore, the first studies demonstrated that U or E-ERCP decreased the mortality and morbidity in severe acute pancreatitis patients compared to the control group [53]. In 1997, Fölsch et al. [54] reported that especially deaths due to respiratory failure were more common in the E-ERCP group than the control group in their randomized controlled trial about the role of E-ERCP in acute biliary pancreatitis. The APEC study [4] that includes 232 patients from 26 centers published in July 2020 compared U-ERCP and conservative treatment, and this study changed the paradigm. Besides, acute biliary pancreatitis patients with cholangitis excluded from the APEC study and no significant difference demonstrated between two groups in regard of local or systemic complications of pancreatitis. Whereas, the cholangitis and recurrent attacks of pancreatitis were more common in the U-ERCP group than the conservative treatment group. This is because the criteria for persistent cholestasis or cholangitis were fever, serum bilirubin levels greater than 2.3 mg / dl, commom bile duct width greater than 8 millimeters in patients younger than 75 years and 1 centimeter in patients older than 75 years, and the presence of stones in common bile duct in this study. Another cause of these findings were that it was unclear whether MRCP or EUS, which are the most sensitive methods in detecting stones in choledoc, were performed or not.
Some conflicting results were obtained in the meta-analysis of randomized controlled trials about the role of emergency ERCP in acute biliary pancreatitis, according to the including and excluding criteria of the involved randomized controlled trials and whether subgroup analysis is done or not. Petrov et al. [55] published a meta-analysis in 2008 including 7 randomized controlled trials with 450 patients about the effects of E-ERCP on acute biliary pancreatitis without cholangitis, and they indicated that emergency ERCP has no effect on local complications of pancreatitis in neither mild nor severe pancreatitis. Van Santvoort et al. [56] compared E-ERCP with conservative treatment in patients with and without cholangitis in their randomized controlled trial and demonstrated that in patients without cholestasis, ERCP (29/75 patients: 39%) was not associated with reduced complications (45% vs. 41%, P = 0.814, multivariate adjusted OR: 1.36; 95% CI: 0.49–3.76; P = 0.554) or mortality (14% vs. 17%, P = 0.754, multivariate adjusted OR: 0.78; 95% CI: 0.19–3.12, P = 0.734).
A meta-analysis by Tse et al. [1] which contains 5 randomized controlled studies, indicated that unweighted pooled mortality rates for participants were 9.6% in the early routine ERCP strategy and 4.9% in the early conservative management strategy in patients without cholangitis. Three years after this meta-analysis, Burstow et al. [49] analyzed 11 RCTs consisting of 1314 patients (conservative management = 662, ERCP = 652). There was a near significant decrease in mortality for the ERCP group compared with conservatively managed patients with severe pancreatitis [odds ratio (OR) 0.45; 95% confidence interval (CI), 0.19, 1.09; P = 0.08]. In patients with mild pancreatitis, mortality results were comparable for both groups (OR 0.66; 95% CI, 0.02, 28.75; P = 0.83). Overall complications were significantly reduced in the ERCP group in severe pancreatitis patients (OR 0.32; 95% CI, 0.17,0.61; P = 0.00). The authors’ comments about this meta-analysis are as follows: this meta-analysis demonstrates a significant decrease in complications in patients with severe ABP managed with early ERCP/ES compared with conservative management. As far as the mortality is concerned, no significant decrease was observed in mortality even in severe ABP patients treated with early ERCP/ES.
The meta-analysis and systematic review about the comparison of E-ERCP and conservative treatment in acute biliary pancreatitis by Coutinho et al. [57] reported that; the pain and fever resolved in a shorter time, the hospitalization time was shorter with reduced complications and hospital costs were lower in the E-ERCP group than the conservative treatment group. Uy et al. [58] performed a meta-analysis including 2 randomized controlled trials that compares the E-ERCP (n = 177) and the conservative treatment (n = 163) in acute biliary pancreatitis. This meta-analysis revealed low mortality rates for both mild and severe pancreatitis in the ERCP group (RR = 1.92, 95% CI: 0.86–4.32) whereas the morbidity rates were similar in both groups (RR = 0.95, 95% CI: 0.74–1.22). Moretti et al. [50] demonstrated that ERCP had no effect on complications in mild pancreatitis however, ERCP reduced the complications in severe pancreatitis but it did not have any effect on mortality rates in their meta-analysis including 5 prospective randomized trials with 702 patients. Geenen et al. [52] preformed a review including 12 international guidelines and 8 meta-analysis. Although 3 meta-analysis and 1 guideline recommended against ERCP in acute biliary pancreatitis, 7 out of 11 guidelines recommended routine E-ERCP in severe acute biliary pancreatitis regardless of the presence of cholangitis, and they agreed on the lack of consensus about routine E-ERCP in severe acute biliary pancreatitis. However, the 4 main international guidelines that we evaluated (2 out of them belonged the same group but published at different times) recommended against the emergency ERCP in acute biliary pancreatitis without cholangitis because it did not significantly reduce mortality and morbidity compared to the conservative treatment group [31, 33, 34, 35]. Contrary to these guidelines, another guideline of the United Kingdom publishe in 2005 [32] has controversial suggestions about E-ERCP in severe acute biliary pancreatitis without cholangitis as; “
Because of the lack of statically significant data about the reduction in local and systemic complications or mortality rates of pancreatitis by emergency ERCP in severe acute biliary pancreatitis from many RCTs and meta-analyzes until to date, international guidelines referring to these results indicated that U- or E-ERCP have no benefit in every patient with severe acute biliary pancreatitis unless cholangitis is present. The ESGE guideline published in 2018 [33] explains why ERCP should not be performed in a patient with severe pancreatitis without cholangitis: “
Certainly, biliopancreatic obstruction should be resolved immediately in patients with cholangitis or persistent cholestasis. The most effective method of this is undoubtedly the removal of stone or sludge that caused the obstruction by performing ERCP and ES [59]. The first study in this area was performed by Neoptolemos et al. and it demonstrated that E-ERCP and ES was the most useful method in acute biliary pancreatitis with cholangitis and cholangitis without pancreatitis [60]. Van Santvoort et al. [56] performed a study about the efficiency of ERCP in acute pancreatitis patient with or without cholestasis and findings as follows: In patients with cholestasis, ERCP (52/78 patients: 67%), as compared with conservative treatment, was associated with fewer complications (25% vs. 54%, P = 0.020, multivariate adjusted odds ratio [OR]: 0.35, 95% confidence interval [CI]: 0.13–0.99, P = 0.049). This included fewer patients with >30% pancreatic necrosis (8% vs. 31%, P = 0.010). Mortality was nonsignificantly lower after ERCP (6% vs. 15%, P = 0.213, multivariate adjusted OR: 0.44, 95% CI: 0.08–2.28, P = 0.330).
Tse et al. [1] performed a meta-analysis which included 5 randomized controlled trials with 644 participants with cholangitis and reported mortality rates, comprising a total of 200 participants in the early routine ERCP strategy and 215 in the early conservative management strategy. Unweighted pooled mortality rates for participants were 1.0% for the early routine ERCP strategy and 6.9% in the early conservative management strategy. In the trials that included participants with cholangitis, the early routine ERCP strategy significantly reduced mortality compared to the early conservative management strategy (RR 0.20, 95% CI 0.06 to 0.68; P = 0.010).
There is no consensus on timing of ERCP in the literature. In most publications, the ERCP preformed within 72 hours after the symptom onset is called emergency ERCP, but the emergency ERCP timing could be defined as within 48 hours in some other publications. Additionally, the ERCP which is performed within 72 hours named as U-ERCP in some publications. The only trial that compares the timing of ERCP (within 24 hours versus within 24–72 hours) in acute biliary pancreatitis is performed by Lee et al. [2]. Patients with acute biliary pancreatitis but without cholangitis was excluded retrospectively in this study, and they compared U-ERCP and E-ERCP in acute biliary pancreatitis. No significant difference was found in the total length of hospitalization or procedural-related complications, in patients with biliary pancreatitis and a bile duct obstruction without cholangitis, according to the timing of ERCP (< 24 h vs. 24–72 h). Although the definition is not U-ERCP, in one of Fan et al.’s studies [45] the ERCP which is performed within 24 hours is defined as E-ERCP and there was no significant difference between the ERCP group and the conservative treatment group in terms of local and systemic complications of pancreatitis whereas hospitalization time was a little shorter in the E-ERCP group. With these results, it was demonstrated that performing U-ERCP within 24 hours did not change the pancreatitis course, supporting the study of Lee et al. [2]. When considering the course of acute biliary pancreatitis, naming the ERCP performed within 24 hours as “URGENT” and the ERCP within 24–72 hours as “EARLY” by Lee et al. is the most appropriate definition [2]. When the literature and international guidelines are reviewed, ERCP is recommended to the acute biliary pancreatitis within 24 hours if the cholangitis is present and within 72 hours if the biliary obstruction is present, instead of this definition.
Although the naming does not resemble, recommendation of ESGE in this respect is as follows: “
Early laparoscopic or open cholecystectomy as soon as AP recovers completely is the only proven treatment modality to prevent recurrence of ABP. Index cholecystectomy is defined as cholecystectomy applied during the same hospitalization period of ABP and interval cholcystectonmy is cholecystectomy performed 6 weeks after patient’s recovery from AP [61].
Sinha and colleagues [61] reported that index cholecystectomy in a case suitable for surgery has similar results with elective cholecystectomy in a patient without AP and they also reported significant difficulty to do dissection during interval cholecystectomy. In 2019, Fu-ping Zhung and colleagues [62] published a meta-analysis of 19 studies enrolling 2639 who underwent index or interval cholecystectomy. They noted that there was no differences with ragard to intraoperative and postoperative complications, duration of operation and the rates of open cholecystectomy. However, index cholecystectomy cases had lesser hospitalization period, lower biliary complications due to surgery and lesser rates of ERCP.
In cases with severe pancreatitis, most of the time it is impracticable to perform index cholcystectomy. Therefore, interval cholcystectomy is obligatory in these cases. Infortunately, these patients reamit with AP attacks and ot biliary complications during this 6 weeks period. Thus some authors offer ERCP and endoscopic sphincteratomy to prevent AP recurrences and or biliary complications to ocur during this time period [63, 64].
In a retrospective study comparing index cholecystectomy and post ERCP/ES plus interval cholecystectomy, both group of patients did not reveal mortality. Only 2 patients (%5) developed AP recurrences and acute cholecystitis and hospitalized. The authors suggested that ERCP/ES is highly successful to prevent recurrences in patients with severe ABP who can not undergo index cholecystectomy. ES and interval cholecystectomy in severe ABP is considered a reasonable alternative to an index cholecystectomy in patients with severe ABP [64].
Another report by Dedemadi and his colleagues [65] published in 2016 noted that ERCP and ES in cases with AP who can not undergo cholecystectomy developed biliary events 0%–28.6%, recurrent pancreatitis 0%–8.2%, mortality 3%–4.7%. Other cases under conservative treatment had biliary events 9.4%–14.3%, recurrent pancreatitis 12%–23%, mortality 3.9%. Statistical evaluation showed that ERCP and ES group had significanly less biliary complications and less recurrent pancreatitis with no difference in mortality compared to conservative treatment group. The conservative group consisted of patients who were elderly persons with multiple comorbidites and complications of AP. These conditions may be responsible for similar mortality rates in both groups. Nevertheless, because of high rates of biliary events and pancreatitis in the ERPC/ES group, this approach should be reserved only for patients not suitaable for cholecystectomy.
The advice of IAP/APA about timing od cholecystectomy in a case with ABP is as follows [31]:
Moreover, If we consider surgery for pancreatic cystic collections, pseudocysyt and or walled off necrosis, it should be performed at the same time with cholecystectomy [65].
We want to finish with the conclsuive statement made by ESGE [35];
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