Insights from Global, National, and Local Studies of Benign Biliary Disease for 2023

Abstract

In the existing literature regarding benign gallbladder and bile duct diseases, there is an insufficient connection between biliary disease-specific descriptive epidemiology and clinical medicine, which are two distinct research areas. Global collaborative, national, single-centre and review studies of benign gallbladder and bile duct diseases and related surgical procedures were examined to gain insights into their highlighted trends, patterns, characteristics, comparisons and suggestions. A comparative analysis of the age-standardised prevalence and incidence of benign biliary diseases across 204 countries and territories changed the global narrative by indicating that they should not be stratified into Western and Eastern because the prevalence and incidence of these diseases mainly depend on the sociodemographic index (SDI) of the country instead of the geographical location or region. A high SDI does not always correspond to a high Healthcare Access and Quality (HAQ) index. Trends in the prevalence and incidence of benign biliary diseases are increasing. Age-standardised mortality rates increased by 25% between 1990 and 2020, and it was estimated that there was a 10% decrease in the total number of cholecystectomies from 2016 to 2019. Damage control and surgery limitations are gaining recognition in England, and this shift in gallbladder surgery has become apparent. A seven-fold increase in subtotal (or partial) cholecystectomies in England was estimated between 2000 and 2019. The trends in the application of tube cholecystostomy were similar. Cholecystolithotomy was performed for 1 of every 1250 patients. Bile duct injury rates are still correlated with high intraoperative difficulty. The suggested terms ‘subtotal open-tract cholecystectomy’ and ‘subtotal closed-tract cholecystectomy’ are distinct, mutually exclusive and consistent with the ideas connecting most works published during the past 124 years. Ethical considerations arising from direct long-term observations of biliary surgery practices and recent publications comprise a grey area of medical research. These insights have improved our understanding of benign gallbladder and bile duct diseases and how to prevent them; however, further evidence-based discussions are required. This work highlights the need to develop precision-based biliary medicine and surgery.

1. Introduction

An analysis of published literature regarding benign gallbladder and bile duct diseases during the past 10–15 years revealed gradually changing global and national epidemiological trends and patterns. Furthermore, it showed that new features of managing these diseases—most related to gallstones—are gaining more recognition. However, a gap in the literature, defined as insufficient information in the established or recently published research, regarding the connection between biliary disease-specific descriptive epidemiology and clinical medicine still exists.

This chapter offers insights into the global and national epidemiology of benign gallbladder and bile duct diseases. Additionally, it shows how to expose the national problem associated with biliary disease-specific health policy planning and implementation using composite measure-specific comparisons between countries. Of particular relevance to surgeons is that the role of standard surgical therapy, in which conventional laparoscopic cholecystectomy is mainstream, has shifted significantly towards less than total cholecystectomy during gallbladder surgery to avoid accidental injury to the surrounding vital structures during dissection of the gallbladder, cystic duct and cystic artery or its branches under extraordinary surgical circumstances. This chapter examines this trend and provides thoughts regarding bile duct injury-related problems. The view on the terminology for subtotal cholecystectomy (STC) and its origin is emphasised. Tube cholecystostomy is another pertinent topic of this chapter. Ethical issues and dilemmas associated with biliary surgery deserve more consideration and attention. Some of them are highlighted in this chapter. Finally, this chapter contemplates the future of biliary surgery.

Insights into descriptive and surgical epidemiology, management of biliary diseases and terminology for specific gallbladder surgical procedures were derived from the Global Burden of Diseases, Injuries and Risk Factors (GBD) study [1, 2], systematic reviews [3, 4, 5], national [6, 7] and local studies of benign gallbladder and bile duct disease management [8, 9, 10, 11, 12, 13, 14, 15, 16]. However, these insights require further evidence-based discussions, especially regarding the development of biliary disease-specific healthcare strategies and policies of the National Health Service (NHS).

Epidemiological estimates of all gallbladder and biliary diseases were extracted from the most recent version of the GBD interactive visualisation tool, Epi Visualisation (http://www.healthdata.org/data-visualization/epi-viz) [17]. The GBD study results were used to produce a table highlighting the biliary disease-specific HAQ indices of 195 countries and territories [18]. Figures were produced using GraphPad Prism version 10.0.3 (217) for macOS (GraphPad Software, Inc., San Diego, California, USA). The results of the CholeS study provide an overview of the frequency of bile duct injuries [19]. Furthermore, eight GBD-specific definitions and principles of their interpretation are provided.

1.1 Definitions

Prevalence is defined as the number of individuals affected by a disease (i.e., prevalent cases) in a population at a specific time, usually mid-year. This is expressed as a proportion of the population. For example, an estimated prevalence of 0.042 of 27,827,831 male individuals in England on 30 June 2019 indicates that there were 1,168,769 male individuals affected by a benign gallbladder or bile duct disease that day (0.042 × 27,827,831). Further, 3,130,504 female individuals were affected by this disease, as determined by the mid-2019 female population estimate of 28,459,130 in England, and the prevalence was 0.11 (0.11 × 28,459,130).

Proportion is defined as the number of cases with a particular characteristic (i.e., benign gallbladder or bile duct disease) in a population.

An incident case is defined as one newly diagnosed case in a population each year (or any given period).

Incidence is defined as the number of new cases per year expressed as a rate (e.g., per individual or 100,000 individuals). This was measured by dividing the number of new cases per year by the mid-year population of a country (or any geographical region). For example, the incidence of gallbladder and biliary diseases of 0.031 per female individual in 2019 indicated 3100 new cases per 100,000 female individuals in 2019.

The cause-specific mortality rate is defined as the number of deaths attributable to a condition per person-year in the entire population and equivalent to the prevalence multiplied by the excess mortality from benign biliary disease.

The excess mortality rate is defined as the number of excess deaths per person-year among the prevalent cases.

An age-standardised rate is defined as the weighted average of the age-specific rates, with the weights representing the proportions of a standard GBD population in the corresponding age groups. The potential confounding effect of age was removed when comparing age-standardised rates computed using a single population formula for all countries.

The SDI is defined as a composite indicator of the social and economic development of countries and territories; it is strongly correlated with the epidemiological patterns of diseases and health outcomes [18]. This is the geometric mean of three indices (0–1) associated with the following three estimates: total fertility rate of those younger than 25 years of age, mean education of those 15 years of age and older and lag-distributed income per capita. Using this interpretation, a geographical location with an SDI of 0 would have the theoretical minimum level of development relevant to health, whereas a location with an SDI of 1 would have the theoretical maximum level.

The terms ‘gallbladder and biliary diseases’, ‘gallbladder and bile duct diseases’ and ‘biliary diseases’ are used synonymously in this work and encompass all episodes of these diseases.

2. Epidemiology

2.1 Comparative analysis of the prevalence and incidence of benign biliary disease that changed the global narrative

The descriptive epidemiology of benign gallbladder and bile duct diseases is mainly related to that of gallstones, which comprise a significant proportion of these diseases. Textbooks have stressed that gallstone diseases affect approximately 5–25% of adults, emphasising a higher prevalence in Western countries than in Eastern ones [20].

The GBD 2019 study enabled users to explore data inputs and epidemiological estimates [17]. Systematic analyses of the epidemiological estimates of the GBD 2019 study have provided the opportunity to change traditional knowledge and reconsider historical paradigms, including the prevalence, incidence and mortality of benign gallbladder and bile duct diseases.

In 2019, the age-standardised prevalence estimates of benign biliary disease were highest in Italy, followed by England, Slovakia, Norway, and Lithuania. They were also similarly high in Japan, Brunei Darussalam, Republic of Korea, Singapore and Mexico. Comparisons of age-standardised incidence rates revealed similar patterns. These findings suggest that to emphasise biliary disease patterns in terms of their prevalence or incidence, countries should not be stratified into Western and Eastern; these findings were mainly dependent on the SDI (not on the geographical location) [18, 21].

2.2 Increasing trends in the prevalence and incidence in England

Between 1990 and 2019, the age-standardised prevalence of benign gallbladder and bile duct diseases among male and female individuals in England doubled (Figure 1). Furthermore, the prevalence of these diseases increased sharply from 2017 to 2019. For both sexes, it reached a maximum level in 2019. By estimating the number of prevalent cases in 2019, it was found that approximately 4.3 million males (1.2 million) and females (3.1 million) could be affected by benign gallbladder and bile duct diseases within the country (Figure 2).

Figure 1.

Age-standardised prevalence rates of benign gallbladder and biliary diseases by sex and year in England from 1990 to 2019. The mean rates are expressed with 95% uncertainty intervals (see vertical lines). For male individuals, they are as follows: 0.023 (0.019–0.027) in 1990, 0.032 (0.027–0.038) in 1995, 0.027 (0.024–0.032) in 2000, 0.025 (0.022–0.028) in 2005, 0.028 (0.024–0.032) in 2010, 0.033 (0.028–0.038) in 2015, 0.033 (0.029–0.039) in 2017 and 0.042 (0.036–0.05) in 2019. For female individuals, they are as follows: 0.055 (0.045–0.068) in 1990, 0.12 (0.098–0.14) in 1995, 0.1 (0.09–0.12) in 2000, 0.077 (0.066–0.09) in 2005, 0.073 (0.063–0.085) in 2010, 0.093 (0.079–0.11) in 2015, 0.077 (0.066–0.092) in 2017 and 0.011 (0.09–0.13) in 2019. Data are available from http://vizhub.healthdata.org/epi/ (accessed 15 and 16 August 2023).

Figure 2.

Age-standardised prevalence of benign gallbladder and biliary diseases by sex and year in England from 1990 to 2019. The mean proportions (number of prevalent cases in a population in the middle of the year) are expressed with 95% uncertainty intervals. For male individuals, they are as follows: 535,495 (442,365–628,624) in 1990; 755,657 (637,586–897,343) in 1995; 648,808 (576,718–768,958) in 2000; 618,895 (544,628–693,162) in 2005; 724,563 (621,054–828,072) in 2010; 891,967 (756,820–1,027,113) in 2015; 906,875 (796,951–1,071,761) in 2017; and 1,168,769 (1,001,802–1,391,392) in 2019. The values for the female individuals are as follows: 1,342,970 (1,098,793–1,660,399) in 1990; 2,971,887 (2,427,041–3,467,201) in 1995; 2,520,338 (2,268,304–3,024,405) in 2000; 1,979,693 (1,696,880–2,313,927) in 2005; 1,953,860 (1,686,208–2,275,043) in 2010; 2,581,401 (2,192,803–3,053,270) in 2015; 2,166,655 (1,857,133–2,588,731) in 2017; and 3,130,504 (2,561,322–3,699,687) in 2019. Data are available from http://vizhub.healthdata.org/epi/ (accessed 15 and 16 August 2023). Population estimates were obtained from the Office of National Statistics.

Using a smaller scale, similar patterns of the age-standardised incidence were observed between 1995 and 2019. Notably, the incidence rate was highest in 2019, when 3100 new cases among 100,000 female individuals (95% uncertainty interval: 2600–3800) and 1200 (95% uncertainty interval: 1000–1500) new cases among 100,000 male individuals were estimated (Figure 3). A female-to-male ratio of 3:1 remained consistent over time.

Figure 3.

Age-standardised incidence rates of benign gallbladder and biliary diseases by sex and year in England from 1990 to 2019. The mean rates per 100,000 individuals are expressed with 95% uncertainty intervals. For male individuals, they are as follows: 600 (500–720) in 1990; 830 (690–990) in 1995; 790 (660–940) in 2000; 780 (660–930) in 2005; 890 (750–1100) in 2010; 1000 (860–1200) in 2015; 1000 (880–1200) in 2017; and 1200 (1000–1500) in 2019. The values for the female individuals are as follows: 1400 (1200–1700) in 1990; 2900 (2400–3500) in 1995; 2800 (2300–3400) in 2000; 2600 (2200–3100) in 2005; 2600 (2100–3100) in 2010; 2900 (2400–3400) in 2015; 2700 (2200–3200) in 2017; and 3100 (2600–3800) in 2019. Data are available from http://vizhub.healthdata.org/epi/ (accessed 15 and 16 August 2023).

Inequality in the prevalence and incidence of benign biliary diseases at the subnational level is a problem. Their prevalence and incidence are higher in the northwestern and northeastern regions of England than in other regions. This should be considered when planning short-term and long-term preventive and healthcare policies, which are inseparable from government-catalysed economic investments in communities within the country with lower SDI because they aim to create the potential for further health and economic gains that expand improvements in the SDI within the country.

2.3 Mortality rates increased by 25% in England

As shown in Figure 4, the age-standardised mortality rates of gallbladder and bile duct diseases are increasing. The mean mortality rates of male and female individuals increased by 23.8% and 28.6%, respectively, between 1990 and 2020. Since 2000, the mean mortality rate has remained the same for both male and female individuals.

Figure 4.

Age-standardised mortality rates of benign gallbladder and biliary diseases by sex and year in England from 1990 to 2019. The mean rates are expressed with 95% uncertainty intervals. For male individuals, they are as follows: 0.000016 (0.000014–0.000018) in 1990, 0.000016 (0.000014–0.000018) in 1995, 0.000016 (0.000015–0.000018) in 2000, 0.000017 (0.000016–0.000018) in 2005, 0.000018 (0.000017–0.000020) in 2010, 0.000019 (0.000018–0.000021) in 2015, 0.000020 (0.000019–0.000022) in 2017 and 0.000021 (0.000019–0.000023) in 2019. For female individuals, they are as follows: 0.000015 (0.000013–0.000017) in 1990, 0.000015 (0.000014–0.000017) in 1995, 0.000016 (0.000015–0.000018) in 2000, 0.000017 (0.000015–0.000018) in 2005, 0.000018 (0.000017–0.000019) in 2010, 0.000019 (0.000018–0.000021) in 2015, 0.000020 (0.000019–0.000022) in 2017 and 0.000021 (0.000019–0.000023) in 2019. Data are available from http://vizhub.healthdata.org/epi/ (accessed 15 and 16 August 2023).

Excess mortality rates attributable to benign biliary diseases were observed for male and female individuals over the course of the past three decades (Figure 5) and were highest in 1995. Furthermore, disparities in excess mortality rates according to sex have continued. For example, the mortality rate for male individuals was higher (by 42.2%) in 1995 than it was in 2019 (by 28.6%).

Figure 5.

Age-standardised excess mortality rates of benign gallbladder and biliary diseases by sex and year in England from 1990 to 2019. The mean rates are expressed with 95% uncertainty intervals. For male individuals, they are as follows: 0.00027 (0.00022–0.00032) in 1990, 0.00045 (0.00037–0.00053) in 1995, 0.00023 (0.00020–0.00026) in 2000, 0.00025 (0.00022–0.00028) in 2005, 0.00024 (0.00021–0.00027) in 2010, 0.00023 (0.00019–0.00026) in 2015, 0.00018 (0.00015–0.00022) in 2017 and 0.00021 (0.00018–0.00024) in 2019. The values for the female individuals are as follows: 0.00015 (0.00012–0.00018) in 1990, 0.00026 (0.00021–0.00033) in 1995, 0.00013 (0.00011–0.00015) in 2000, 0.00016 (0.00014–0.00019) in 2005, 0.00018 (0.00015–0.00020) in 2010, 0.00016 (0.00013–0.00018) in 2015, 0.00018 (0.00015–0.00022) in 2017 and 0.00015 (0.00013–0.00018) in 2019. Data are available from http://vizhub.healthdata.org/epi/ (accessed on 15 and 16 August 2023).

The fact that there has been no reduction in the mortality rate caused by biliary diseases over the course of the past two decades should be viewed critically, and an analysis of the root causes of this phenomenon is warranted.

2.4 High SDI does not always correspond to a high HAQ index: Benign biliary disease is an example

The HAQ index is a composite metric that summarises personal healthcare access and quality within a given geographical location. This measure is based on risk-standardised mortality rates or, for cancers, mortality-to-incidence ratios attributable to causes that, in the presence of quality healthcare, should not result in death, which is also known as amenable mortality [18]. Table 1 displays the rankings of the countries based on gallbladder and biliary disease-specific HAQ indices and provides more details regarding the HAQ index. Table 1 also shows the HAQ indices calculated based on the 32 causes of death that should not result in death in the presence of effective care to approximate personal healthcare access and quality. The comparison of two HAQ indices for one country or territory and between countries or territories provides an opportunity to reflect on how healthcare systems prioritise services for those affected by benign gallbladder and bile duct diseases.

Rank	Country	HAQ index, biliary disease specific	HAQ index	Rank	Country	HAQ index, biliary disease specific	HAQ index
1	Greece	100	24	99	Mauritania	68	146
2	Qatar	100	41	100	Hungary	66	40
3	Kuwait	100	44	101	Argentina	66	83
4	Oman	100	54	102	Chile	65	49
5	Macedonia	100	57	103	Vietnam	65	108
6	Sri Lanka	100	71	104	Sudan	65	136
7	Maldives	100	72	105	Taiwan (Province of China)	64	34
8	Syria	100	88	106	Bangladesh	63	133
9	Norway	99	2	107	Ghana	63	153
10	Australia	99	5	108	Grenada	61	110
11	Switzerland	99	7	109	Uruguay	60	68
12	Austria	99	13	110	Greenland	59	86
13	Canada	99	14	111	Peru	59	94
14	Lebanon	99	33	112	India	59	145
15	Bermuda	99	37	113	The Gambia	58	157
16	Albania	99	56	114	Yemen	56	140
17	Iraq	99	125	115	Nepal	56	149
18	Iceland	98	1	116	Guatemala	55	123
19	Sweden	98	8	117	Equatorial Guinea	55	129
20	Malta	98	27	118	Mali	55	159
21	Bulgaria	98	51	119	The Bahamas	54	90
22	New Zealand	97	16	120	Liberia	54	166
23	France	97	20	121	Malaysia	53	84
24	Dominican Republic	97	106	122	Ecuador	53	101
25	Luxembourg	96	4	123	South Africa	53	127
26	Finland	96	6	124	Fiji	53	131
27	Estonia	96	31	125	Samoa	53	132
28	Romania	96	47	126	Benin	53	177
29	Georgia	96	89	127	Timor-Leste	52	139
30	Andorra	95	10	128	Brunei	51	53
31	Germany	95	18	129	Virgin Islands	51	61
32	Ireland	94	11	130	Thailand	51	76
33	Belgium	94	15	131	North Korea	51	120
34	USA	94	29	132	American Samoa	50	109
35	Ukraine	93	59	133	Pakistan	50	154
36	Netherlands	92	3	134	Cameroon	50	171
37	Italy	92	9	135	Belize	49	116
38	Poland	92	39	136	Suriname	49	118
39	Azerbaijan	92	92	137	Botswana	49	122
40	Saudi Arabia	91	52	138	Laos	49	155
41	Mauritius	91	79	139	Djibouti	49	158
42	Japan	90	12	140	Burkina Faso	49	178
43	Denmark	90	17	141	Armenia	48	70
44	Spain	89	19	142	Colombia	48	81
45	Israel	89	35	143	Philippines	48	124
46	Iran	89	66	144	Gayana	48	126
47	Slovenia	88	21	145	Senegal	48	175
48	Tunisia	88	77	146	Mexico	46	91
49	Latvia	87	43	147	Sierra Leone	46	176
50	Turkey	87	60	148	Northern Mariana Islands	45	63
51	Singapore	86	22	149	Paraguay	45	115
52	Seychelles	86	93	150	São Tomé and Príncipe	45	152
53	Jamaika	86	102	151	Niger	45	183
54	Montenegro	85	42	152	Togo	44	169
55	Libya	85	67	153	Guinea-Bissau	44	193
56	Barbados	85	69	154	Brazil	43	96
57	Algeria	84	99	155	Namibia	43	137
58	Belarus	83	46	156	Marshall Islands	43	141
59	Serbia	83	50	157	Chad	43	192
60	United Arab Emirates	83	73	158	Kenya	42	150
61	Croatia	82	30	159	Tanzania	42	161
62	Portugal	82	32	160	South Sudan	42	188
63	UK	81	23	161	Guinea	42	190
64	China	81	48	162	Swaziland	41	147
65	Jordan	81	74	163	Indonesia	39	138
66	Moldova	80	87	164	Mozambique	39	179
67	Morocco	80	112	165	Côte d’Ivoire	39	187
68	Czech Republic	78	28	166	Mongolia	36	119
69	Saint Lucia	78	97	167	Afghanistan	36	191
70	El Salvador	78	98	168	Bolivia	35	130
71	Dominica	78	103	169	Rwanda	35	156
72	Saint Vincet and Grenadines	78	113	170	Comoros	35	163
73	Cape Verde	78	117	171	Federates States of Micronesia	34	144
74	Bahrain	77	65	172	Gabon	34	148
75	Antiqua and Barbuda	76	75	173	Haiti	33	168
76	Bosnia and Herzegovina	75	64	174	Angola	31	162
77	Turkmenistan	75	104	175	Uganda	29	173
78	Nicaragua	75	105	176	Madagascar	29	180
79	South Korea	74	25	177	Tonga	28	128
80	Cyprus	74	26	178	Lesotho	28	170
81	Puerto Rico	74	38	179	Malawi	27	167
82	Russia	74	58	180	Ethiopia	26	184
83	Uzbekistan	74	100	181	Vanuatu	25	164
84	Slovakia	73	36	182	Cambodia	24	151
85	Kazakhstan	73	78	183	Solomon Islands	24	165
86	Venezuela	73	85	184	Burundi	24	186
87	Palestine	73	114	185	Egypt	23	111
88	Lithuania	72	45	186	Eritrea	23	185
89	Tajikistan	72	121	187	Papua New Guinea	21	172
90	Costa Rica	71	62	188	Kiribati	21	189
91	Bhutan	71	134	189	Congo (Brazzaville)	20	160
92	Nigeria	71	142	190	Somalia	20	194
93	Cuba	70	55	191	Zambia	16	182
94	Guam	70	80	192	Democratic Republic of the Congo	15	181
95	Panama	70	82	193	Zimbabwe	6	174
96	Trinidad and Tobago	70	95	194	Honduras	5	135
97	Myanmar	69	143	195	Central African Republic	4	195
98	Kyrgyzstan	68	107

Table 1.

HAQ indices of gallbladder and biliary diseases by country or territory in 2016.

HAQ indices are reported based on a scale of 1–100. Index 0 represents the worst level. Index 100 represents the best healthcare access and quality levels. This table was constructed using data from the Healthcare Access and Quality Collaborators 2016 [18]. Countries ranked from 1 to 20 comprise the first decile according to the HAQ index. Countries ranked from 21 to 40 comprise the second decile. Countries ranked from 31 to 60 comprise the third decile. Countries ranked from 61 to 80 comprise the fourth decile. Countries ranked from 81 to 100 comprise the fifth decile. Countries ranked from 101 to 120 comprise the sixth decile. Countries ranked from 121 to 140 comprise the seventh decile. Countries ranked from 141 to 160 comprise the eighth decile. Countries ranked from 161 to 180 comprise the ninth decile. Countries ranked from 181 to 195 comprise the tenth decile. HAQ = Health Access and Quality.

Biliary tract-specific HAQ index patterns vary considerably across countries and territories. These patterns followed a distinct geographical pattern in 2016, with the highest decile (rank: 1–20) comprising Arab countries (Qatar, Kuwait, Oman, Syria, Lebanon, Iraq), Southern Europe (Greece, Macedonia, Albania, Malta), Central Europe (Switzerland, Austria), Nordic countries (Norway, Island, Sweden), Australia, Canada, Sri Lanka, Maldives and Bermuda. A majority of countries in the lowest decile (rank: 181–195) were located in sub-Saharan Africa, with a few exceptions.

Less heterogeneity of the biliary disease-specific HAQ index emerged in the second decile, which mainly included continental European countries and the United States. New Zealand and the Dominican Republic were among this decile as well.

Notably, the United Kingdom, which has a high SDI, was in the fourth decile (rank: 61–80), with a biliary disease-specific HAQ index of 81 and rank of 63 in 2016. The fact that the United Kingdom was in the second decile with a 32-cause HAQ index of 90 reflects the necessity for more in-depth exploration of the causes of suboptimal gallbladder and biliary disease-specific HAQ indices in all four countries of the United Kingdom, where the NHS is the dominant healthcare provider. Reports of the three-fold difference in the number of cholecystectomies for benign gallbladder diseases performed across various clinical groups (range: 48–177 cholecystectomies per 100,000 individuals of all ages in England between April 2014 and March 2015) have stressed the consequences of these diseases [22]. Such inequalities in healthcare provided to patients with symptomatic and complicated gallstone diseases undoubtedly negatively affect the gallbladder and biliary disease-specific HAQ index and the country’s rank.

Well-known postulates, such as the decrease in the number of referrals to secondary care and discrepancies in the thresholds for performing gallbladder surgery according to some NHS Trusts and NHS Foundation Trusts (all accountable to clinical commissioning groups), require additional analyses of the root cause [6, 7]. However, the access to, functionality of, and quality of biliary surgery services are the responsibilities of each organisation providing healthcare. When these responsibilities are not fulfilled, patients with gallbladder and biliary tract diseases encounter difficulties receiving the required service within an acceptable time in England [22, 23, 24, 25, 26, 27].

Many healthcare executives and clinical leaders hesitate to accept that insufficient care for patients with biliary diseases is a major problem within their organisations. Shortages of healthcare facilities, operating theatres and workforce necessary to provide surgical care contribute to this problem; however, these shortages are preventable.

3. Surgery

3.1 Total cholecystectomy: a 10% decrease in England during 2016–2019

Fewer elective cholecystectomies were performed in England during 2016–2019. However, the annual number of unplanned cholecystectomies did not change; 7975 patients underwent emergency total cholecystectomy in 2000, and the same number of patients underwent this procedure in 2019 [6, 7]. This finding suggests that the implementation of national and international guidelines for acute cholecystitis management is problematic for hospitals in England [22, 23, 24, 25, 26, 27].

It is necessary to determine whether the 10% decrease in the number of total cholecystectomies between 2016 and 2019 was reciprocally correlated with the prevalence and incidence of benign gallbladder diseases in England. However, an analysis of epidemiological estimates (Section 2.2) suggested that it was not reciprocally correlated (Figures 1–3) because the unmet need for cholecystectomy increased. Additionally, the mortality rate consistently exceeded zero. Thus, the decrease in the number of total cholecystectomies resulted from a decrease in the provision of biliary surgery services at the national level. When the coronavirus disease 2019 (COVID-19) pandemic began in England in 2020, this problem deepened [28].

3.2 A shift towards damage control surgery reflects the changing patterns of gallbladder surgery

3.2.1 Subtotal cholecystectomy: a seven-fold increase in England from 2000 to 2019

STC, which is an alternative to conventional cholecystectomy, was designed to avoid bile duct injury under challenging surgical circumstances [5]. A single-centre cohort study of 180 adult patients who underwent STC between 2011 and 2018 revealed a steady increase in STC rates over time [8, 9]. Stratification of the cohort into six subgroups according to the surgical setting (elective or nonelective), surgical approach used (open or laparoscopic) and STC type (reconstituting or fenestrating) showed the same trends in each subgroup. Because it was assumed that a substantial increase in the performance of STC for benign gallbladder diseases might be observed across the country, these were the prerequisites for a nationwide study of gallbladder surgery in England between 2000 and 2019.

A nationwide analysis of gallbladder surgery in England was published in 2022 [6, 7]. Notably, 18,438 subtotal cholecystectomies (1.5% of 1,234,319 gallbladder surgeries) were performed over the course of 20 years. The most striking findings of this study were an increase in subtotal cholecystectomies by 716.6% (n = 217 in 2000; n = 1772 in 2019) and a 4.7-fold decrease in the ratio of total cholecystectomies to subtotal cholecystectomies (180:1 in 2000 vs. 38:1 in 2019). The patterns of increases in elective and emergency subtotal cholecystectomies were similar. Similar trends were observed among both male and female individuals. Similarly, a nationwide study conducted in the United States reported increased rates of open cholecystectomy (from 0.10% to 0.52%) and laparoscopic STC (from 0.12% to 0.28%) for acute cholecystitis in 2003 and 2014, respectively [29].

Gallbladder surgery trends in other countries, especially those with a high SDI and developed medicolegal systems, remain unclear. However, an increase in the performance of STC is probable in those countries [3, 4, 5]. During a systematic review published in 2021, 85 studies of STC were characterised [3, 4]. These studies were conducted in 29 countries across 6 continents. Most studies (n = 54; 63.5%) were conducted in the following six countries: Japan (n = 13), India (n = 12), the United Kingdom (n = 11), the United States (n = 9), Turkey (n = 5) and Pakistan (n = 4). Additional studies of global surgical epidemiology are warranted. The Global Evaluation of Cholecystectomy Knowledge and Outcomes (GECKO) study, which is an international observational study, will provide new global knowledge of gallbladder surgery patterns in these countries [30].

3.2.2 Subtotal cholecystostomy and tube cholecystostomy trends are similar

Several studies have highlighted similar trends in cholecystostomy [31, 32, 33], the variable use of this surgical procedure across different regions in the United States [31], and its increased utilisation for low-risk patient cohorts [32]. In England, a seven-fold increase was noted in the cholecystostomy rate from 2000 to 2019 [6, 7].

Because elderly patients often have more severe gallbladder diseases and multiple comorbidities, cholecystostomy was thought to be a relatively safer choice for this patient cohort and is considered a ‘surgical bridge’ between emergency admission with acute severe cholecystitis and definitive gallbladder surgery for some patients. However, this paradigm was challenged by a randomised controlled trial that found that cholecystectomy was superior to percutaneous cholecystostomy, even for high-risk patients [34].

Our recent clinical audit of 76 percutaneous tube cholecystostomies revealed that this surgical procedure is burdensome for patients [15, 16]. Almost two-thirds of patients (n = 47; 61.8%) experienced at least one complication. Seven patients (9.2%) died. Six (7.9%) patients required urgent cholecystectomy during the index admission. One-third of the discharged patients (n = 23; 33.3%) required emergency readmissions because of acute cholecystitis recurrence. Only 12 (17.4%) patients underwent elective cholecystectomy, with a median interval between tube cholecystostomy and elective cholecystectomy of 62.5 days (interquartile range: 20.3–118 days) [15].

An assessment of the indications for percutaneous cholecystostomy indicated that 29 patients (38.2%) met the criteria for grade 3 (severe) cholecystitis [16] according to the Tokyo acute cholecystitis severity grading system [35]. These data showed that according to the Tokyo guidelines standard defined in the management bundle for acute cholecystitis, percutaneous cholecystostomy is overperformed [35]. Therefore, clinicians should carefully consider the selection criteria for percutaneous cholecystostomy. STC, when appropriate under extraordinary surgical circumstances, is an acceptable alternative for physiologically stable patients with acute calculous cholecystitis.

3.2.3 Subtotal cholecystostomy: underestimation is highly probable

Data obtained from the National Hospital Episode Statistics data repository for England showed that of 1,234,319 surgical procedures for the gallbladder, 18,438 were subtotal cholecystectomies [6, 7]. However, difficulty interpreting the correctness of this proportion of 1.5% has arisen when compared to the reported STC rates of individual English institutions. It is necessary to mention that the literature regarding STC is sparse in England.

Ten studies conducted at healthcare facilities in England were reviewed. The STC proportion at each institution and that at the national level by year are shown in Table 2 [8, 36, 37, 38, 39, 40, 41, 42, 43, 44]. They differed substantially and were much higher (range: 1.6–11.6) at nine individual centres [8, 36, 37, 38, 39, 40, 41, 42, 43]. This probable underestimation is related to substandard operation naming, notes, and, consequently, medical coding of the surgical procedure.

First author	Journal	Year	Subtotal cholecystectomy		National estimate
			Cases	Percentage*	Percentage
Rohatgi A [36]	Surg End	2006	5	1.6	1.1
Sinha I [37]	Br J Surg	2007	28	3.2	1.0
Philips JAE [38]	Surg End	2007	26	1.4	1.0
Balakrishnan S [39]	JSLS	2008	70	5.3	1.2
Singhal T [40]	Surgeon	2009	52	4.5	1.3
Harilingam MR [41]	J Min Access Surg	2016	64	6.5	2.2
Lunevicius R [8]	J Laparoendosc Adv Surg Tech A	2021	180	7.2	NA
Jenner [42]	Acta Chir Belg	2022	99	11.6	NA
Ibrahim [43]	Ann R Coll Surg Engl	2023	97	1.7	NA
Bodla [44]	Cureus	2023	50	1.15	NA

Table 2.

Studies of subtotal cholecystectomy in England.

*

The proportion was calculated from the total number of cholecystectomies.

Individual institution-specific subtotal cholecystectomy proportions and national estimates.NA = not available. Surg End = Surgical Endoscopy and Other Interventional Techniques. Br J Surg = British Journal of Surgery. JSLS = Journal of the Society of Laparoscopic and Robotic Surgeons. J Min Access Surg = Journal of Minimal Access Surgery. J Laparoendosc Adv Surg Tech A = Journal of Laparoendoscopic and Advanced Surgical Techniques. Acta Chir Belg = Acta Chirurgica Belgica. Ann R Coll Surg Engl = Annals of the Royal College of Surgeons of England.

3.2.4 Cholecystolithotomy: 1 of 1250 patients

Most patients who undergo cholecystolithotomy are 70–74 years of age. Cholecystolithotomy is performed twice as frequently in elective surgical settings. Therefore, this surgical procedure is more likely to be performed for female patients. It is a bailout surgical procedure for high-risk patients; for those with difficult surgical circumstances, such as fistulous cholecystitis, contracted gallbladder and severe cholecystitis with pericholecystitis; and when the general surgeon has insufficient experience with gallbladder surgery, intrahepatic gallbladder, septic shock requiring immediate surgical intervention, liver cirrhosis, portal hypertension and extensive dense adhesions that only allow visualisation of the gallbladder fundus. Notably, 968 cholecystolithotomies (0.08%) were performed in England between 2000 and 2019 [6].

3.3 Bile duct injury rates are correlated with high intraoperative difficulty

Because there are no International Statistical Classification of Diseases and Related Health Problems (ICD) codes for iatrogenic injuries of all types (or classes) of bile ducts, it is impossible to provide direct estimates of bile duct injuries. Therefore, it is unclear whether an increase in STC is reciprocally correlated with bile duct injury rates in England. The results of national snapshot audits and systematic reviews cannot be broadly generalised at the population level. However, they provide useful data and insights regarding bile duct injuries and their prevention.

According to the CholeS snapshot audit results, the proportion of difficult cholecystectomies performed for the CholeS cohort of almost 9000 patients was 9%. Thirteen patients with intraoperative cholecystectomy difficulty grade 4/5 experienced an extrahepatic bile duct injury, resulting in an injury rate of 1.7%, which was 56-times higher than the injury rate for difficulty grade 1, 9- to 10-times higher than the injury rate for difficulty grade 2 or grade 3, and almost 7-times higher than the overall bile duct injury rate of 0.25% [19].

A high intraoperative difficulty grade [45, 46] is the only justification for timely injury-free conversion from total cholecystectomy to STC to minimise or avoid the risk of injury to the extrahepatic bile ducts [13, 14]. However, all adjunct procedures for total cholecystectomy to treat severe gallbladder diseases, such as STC, tube cholecystostomy, and, in rare cases, cholecystolithotomy, should be used liberally when the surgeon does not feel safe starting cholecystectomy or, if started, dissecting the hepatocystic area [47]. This is an essential part of the culture of safety for cholecystectomy [12, 26, 48].

3.4 Left-sided gallbladder is a risk factor for injury

Two systematic reviews of the management of left-sided gallbladder in 90 and 55 patients revealed extraordinarily high rates—4.4% [49] and 7.3% [50], respectively—of major injury to the bile ducts. These findings suggest that left-sided gallbladder should be considered an additional risk or aggravating factor when prognostically and intraoperatively grading the laparoscopic cholecystectomy difficulty. Emphasising an approach to prevent bile duct injury with left-sided gallbladder, especially during acute care surgery, should supplement the culture of safety for cholecystectomy.

4. Terminology

4.1 The terms ‘subtotal open-tract cholecystectomy’ and ‘subtotal closed-tract cholecystectomy’ are practical

Medical and surgical terms should be precise, concordant with anatomical terms, logical, short, straightforward, effortless to pronounce, valid from a linguistic point of view, and easily translatable to other languages, including medical Latin. They also reflect the evolution of medical terminology.

Recently, in 2023, the terms ‘subtotal open-tract cholecystectomy’ and ‘subtotal closed-tract cholecystectomy’ [5, 13, 14] were suggested to correspond to the aforementioned requirements. These two terms are distinct, mutually exclusive and consistent with the ideas that connect most publications during the past 124 years [5].

However, the two terms suggested in 2016—subtotal fenestrating cholecystectomy and subtotal reconstituting cholecystectomy [51]—were unprecise (e.g., the term ‘subtotal fenestrating cholecystectomy’ includes two distinct variants of STC, with and without cystic duct closure), long, not straightforward, and difficult to translate or untranslatable to other languages, especially those that are not descended from Latin. Additionally, from a linguistic point of view, the word ‘fenestrating’, which specifies the removal of the peritoneal wall of the gallbladder (minimum of 75% of the gallbladder perimeter), is incorrect because the Latin word ‘fenestra, -ae, genus femininum’ approximately means ‘window’ or ‘small opening’, and it is used to describe a pore in an anatomical structure.

STC is broadly characterised as closed-tract or open-tract STC. When the gallbladder remnant or cystic duct is closed, regardless of the technique used, the surgical procedure is called closed-tract STC. When the gallbladder remnant or cystic duct is not closed, the surgical procedure is referred to as open-tract STC [5, 13, 14]. The probability of bile leakage is what separates the two distinct types of subtotal cholecystectomies. Open-tract STC is an independent predictor of bile leakage after STC (odds ratio: 7.07; 95% confidence interval: 2.191–25.89; P = 0.0170) [13].

4.2 Subtotal cholecystectomy is a principle-based multimodal surgical procedure

The gallbladder resection variant (or method) and resection type are two different characteristics. The terms ‘subtotal open-tract cholecystectomy’ and ‘subtotal closed-tract cholecystectomy’ broadly characterise the second stage of STC, post-resection. These two terms do not provide information regarding the first stage of STC, gallbladder resection. The variants of it have been described by reviews of partial resection of the gallbladder [5, 10, 52].

Four technical variants describe gallbladder resection [9, 10, 13, 14]. STC variant 1 (STC-1) involves circumferential partial removal of the peritoneal and hepatic walls of the gallbladder. Because of its technical execution, STC-1 is subclassified into the following three subvariants: STC-1A (fundus-down first, circular transection of the proximal portion of the gallbladder second); STC-1B (transection of the proximal portion of the gallbladder first, fundus-up second); and STC-1C (partial removal of the visceral wall first, partial removal of the hepatic wall second).

During STC-2, the peritoneal wall is resected, either without (STC-2A) or with (STC-2B) closure of the cystic duct. As a result of this surgical technique, the entire hepatic wall, or part of it in favourable situations, can remain in situ.

STC-3, also known as fundectomy, is a circular excision of the fundus of the gallbladder. A chronic inflammatory mass involving the body and neck of the gallbladder in high-risk patients is an indication of STC. In this scenario, the gallbladder remnant should remain open and should be drained because a cholecystointestinal fistula is probable. The patterns of subhepatic drainage depend on local intraoperative circumstances. For example, the insertion of a drain into the cavity of the gallbladder remnant is one option. An additional lateral and medial incision of the gallbladder to expose the gallbladder cavity as much as possible after fundectomy and drain the subhepatic space is another option (although it is rarely applied). For other cases, standard drainage of the subhepatic space is the best option. STC-4 involves resection of a small part of the peritoneal wall of the gallbladder.

The schemes of every variant and subvariant are available in open-access publications (https://data.mendeley.com/datasets/khv3b7b6wf/1 [pages 104–108]; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7099162/; and frontiersin.org [Frontiers State of the art in STC: An overview]) [9, 10, 52]. An understanding of these factors facilitates the execution of STC. Additionally, a precise description of STC is essential if complete cholecystectomy is necessary. This procedure could be named laparoscopic subtotal closed-tract cholecystectomy 1B or laparoscopic closed-tract STC-1B.

5. Ethical considerations: a new paradigm for measuring dimensions of dishonest practice

The document titled ‘Best practice for laparoscopic cholecystectomy documentation’ aimed to assist operating surgeons with producing a record of quality laparoscopic cholecystectomy [53]. This document was developed based on an analysis of the existing guidelines and NHS documents. It provides 32 recommendations for the documentation of practice for all patients undergoing laparoscopic cholecystectomy and four case vignettes. This document was published in 2022. It suggests that laparoscopic cholecystectomy operative notes have been regarded as substandard for many years in England. This could also imply that other preoperative (consulting surgeon and patient relationships regarding consent, informed consent quality and shared decision-making) and postoperative actions were suboptimal for many years in the country. A study of patient-specific and setting-specific factors that influenced the quality of informed consent between 2013 and 2017 revealed that among 174 patients who underwent resection of part of the gallbladder, only 9 (5.2%) had been informed about the possibility of STC as an alternative surgical management [11]. Furthermore, wide variations in cholecystectomy practices among consulting surgeons have been reported. For example, the proportion of subtotal cholecystectomies varied from 0.7% (extremely low) to 71.6% (unacceptably high) [8]. These figures present more questions than answers. Only an independent review of individual cholecystectomy practices can provide answers regarding human factors, outliers [9], the prevailing culture within organisations, and, most importantly, patient rights-based morality, which is the dominant contemporary theme of medical ethics and the cornerstone of medical law [54].

Issues related to ethical dilemmas based on the surgeon–colleague perspective are another grey area in the contemporary literature. For example, the correctness of operative records is of paramount importance because it is a source of information for colleagues (to facilitate the best patient care) as well as administrative (to code the surgical procedure precisely), scientific (to collate surgery-specific data prospectively or retrospectively), and judicial (in the event of enquiries into allegations) applications [12]. Therefore, according to the Good Surgical Practice Guide, imprecise documentation of cholecystectomy can be interpreted as misconduct by other surgical team members [55].

Using the terms ‘nearly total cholecystectomy’ and ‘laparoscopic cholecystectomy’ in the operative notes (when a part of the gallbladder was removed) instead of ‘subtotal cholecystectomy’ or ‘partial cholecystectomy’ is an example of a lack of accuracy and almost always intentional. Similarly, the term ‘subtotal cholecystectomy’ instead of ‘cholecystolithotomy’ is also useful for clinical vignettes. Iatrogenic injuries of the bile duct and/or bowel, documented as Mirizzi syndrome and the intentional avoidance of registering surgical procedure-related adverse events with Risk Management Information Systems are other topics that should be explored when reviewing such practices and behavioural patterns using a framework of medical ethics or good clinical practice guide. The goals of collecting and managing data regarding adverse events during gallbladder surgery are to identify learning points and positively implement improvement programmes, and they should not be compromised. Nonetheless, it is necessary to discuss and gradually introduce a new method of measuring and tracking dishonest behaviour within healthcare organisations [56]. It has been shown that the magnitude of dishonesty depends on the characteristics of the individual and context of the situation [57]. Because of medicolegal and other consequences, the incentive to misreport is powerful in the field of biliary surgery.

6. Final comment

This study of benign biliary disease epidemiology, management, terminology and ethics confirmed the necessity for precision-based biliary medicine, including surgery. Assistive robotic systems have become widespread in the United Kingdom and other countries. In the future, autonomous robots will help with gallbladder and bile duct surgeries [58] because they can perform these procedures in a standardised manner and eliminate the impact of operator variability on inconsistent clinical outcomes.