Professor J Peter A Lodge MD FRCS FEBS Consultant Surgeon, Leeds Teaching Hospitals NHS Trust www.peterlodge.com
Surgical removal of the gallbladder by cholecystectomy is now one of the most commonly performed abdominal operations in the West, with rates approaching appendicectomy in the United Kingdom.
According to the Royal College of Surgeons of England and the Association of Upper Gastrointestinal Surgeons (AUGIS), around about 57,000 cholecystectomies were performed in England in 2012 but interestingly there was more than a threefold variation across clinical commissioning group (CCG) areas, ranging from 112 procedures per 100,000 population to 371 procedures per 100,000 population. Whilst commonly viewed as routine, it remains an operation that can be fraught with difficulty and danger.
Most patients with symptomatic gallstones present with a self-limiting attack of pain, known as biliary colic, that lasts for only a few minutes or hours. This can often be controlled successfully by GPs in primary care with appropriate analgesia, avoiding the requirement for emergency admission, but when pain cannot be managed or if the patient is otherwise unwell, then there is a need for referral to hospital as an emergency. Further episodes of biliary pain can be prevented in around 30% of patients by adopting a low fat diet as ingestion of fat promotes the release of cholecystokinin, a hormone which precipitates gallbladder contraction and this results in biliary pain. However, patients should be referred to hospital as an emergency if they have with features of acute cholecystitis (gallbladder infection), cholangitis (infected bile) or acute pancreatitis (inflammation of the pancreas), as these are life threatening conditionsand because cholangitis and pancreatitis are most often caused by a stone that has left the gallbladder and passed into the common bile duct and this can sometimes also result in the development of jaundice.
In the most usual situation, patients with gallstones experience episodes of epigastric (upper central) or right upper quadrant abdominal pain, frequently radiating to the back. These patients should have liver function tests checked and be referred for an ultrasound examination. Confirmation of gallstones should then result in a discussion with the GP of the merits of a referral to a surgical service regularly performing cholecystectomies. However, in patients with significant co-morbidities, the risks of surgery may outweigh the benefits. In patients with gallstones, the decision to operate should be made by the patient but with guidance from the surgeon. This will include assessment of the risk of recurrent symptoms and complications of the gallstones (50% risk per annum of further episode of biliary colic and 1–2% risk per annum of development of serious complications), and the risks and complication rates of surgery in relation to the individual patient’s co-morbidities and preference. These are important issues when considering consent for surgery. The laparoscopic approach to cholecystectomy is the standard for the majority of patients and most should expect to undergo surgery under general anaesthesia as a day-case. Indeed, the laparoscopic approach has revolutionised gallbladder surgery in terms of rapid recovery, with most patients expecting to be back to all normal activities within about 10 days.
In a cholecystectomy operation, whether open or laparoscopic, the surgeon attempts to identify the triangle of Calot. This was described by Calot as an isosceles triangle with the common hepatic duct at its base, the inferior edge of the cystic duct and the superior border of the cystic artery as its sides.1 Having identified these anatomical structures, the surgeon then ligates or clips the cystic duct and cystic artery, divides them and removes the gallbladder by freeing it up from the undersurface of the liver. The difficulty for surgeons is that the inflammatory process associated with gallstones and cholecystitis can make the anatomy hard to determine accurately at the time of surgery.
The introduction of laparoscopic cholecystectomy was unfortunately associated with an increased incidence of bile duct injury.2In 1995, McMahon et al reported the incidence of bile duct injury in open cholecystectomy to range from 0% to 0.5%, an average of one bile duct injury in every two hundred to three hundred cases of open cholecystectomy. Laparoscopic cholecystectomy appeared at that time to be associated with an increased risk of between 0% and 2.8% and this was thought to relate to a “learning curve” as the new procedure was being developed. The overall mean incidence appeared to be 0.3% in 1995, close to that of open cholecystectomy and this rate has not really changed over the years since then. McMahon et al suggested that the incidence of laparoscopic bile duct injury could be reduced by techniques related to careful dissection, definition of the anatomy of Calot’s triangle and lack of hesitation of converting to open cholecystectomy if the anatomy could not be safely identified or if troublesome bleeding occurred.
Way et al applied human performance concepts in an attempt to understand the causes of laparoscopic bile duct injury in order to try to prevent it.3 They identified the primary cause of error in 97% of cases to be a visual perceptual illusion. Faults in technical skill were present in only 3% of injuries. 25% of injuries were recognised at the index operation although only 6% were identified at an early enough stage to limit the injury that occurred. They attributed this to difficulties in understanding the exact anatomy that was seen during the surgery and review of video tapes demonstrated the persuasiveness of the illusion in what in many cases were thought to be routine operations. In summary, their data suggested that errors leading to laparoscopic bile duct injuries stem principally from misperception, not errors of skill, knowledge or judgement. What I mean by this is that it is possible for a very skilled surgeon to misinterpret anatomy during surgery, particularly laparoscopic surgery such that an injury may occur and not be recognised. However, most experts agree that whilst this is an explanation about how bile duct injuries may occur it is not a defence.
Although, some experts suggest that carrying out an intraoperative cholangiogram (an x-ray examination of the bile ducts) during cholecystectomy may reduce the incidence of bile duct injury, this remains a matter for debate as there is little evidence to suggest that intraoperative cholangiography prevents bile duct injury. There is, however, some evidence to suggest it may allow earlier recognition or lessen the injury that occurs.4 So, in my opinion, although many experts argue that failure to carry out a cholangiogram during a cholecystectomy operation is negligent this is based on bias from their own practises and it is not an argument that should stand up in court.
Perhaps the most convincing approach to prevention of bile duct injury during cholecystectomy is the use of the “critical view of safety” as described by Strasberg in 1995.5 In this technique, the triangle of Calot is cleared of fat and fibrous tissue until two and only two structures can be seen entering the gallbladder. Furthermore, the lower third of the gallbladder’s attachment to the liver is dissected free such that there is a wide clear angle visible prior to applying clips. If this critical view cannot be achieved then a cholangiogram (performed to aid clarification of anatomy) or conversion to an open procedure is mandatory. This approach has become the standard practice of many surgeons in their approach to laparoscopic cholecystectomy and indeed the Dutch Society of Surgery has made it mandatory that the critical view image should be recorded photographically prior to division of the cystic duct as a quality standard.6 In the UK, a reasonable body of general and hepatobiliary surgeons should argue that this approach demonstrates exemplary care during the surgery but in this instance it would be for the Court to decide if an injury constitutes negligence should it occur despite using this method. Photographic or intra-operative video evidence from the operation itself may be helpful for an expert to determine what has gone wrong.
An initially unrecognised injury to the bile duct at cholecystectomy usually results in the development of an abdominal bile collection. Although some experts may suggest that this should be recognised at an early stage, it can be notoriously difficult. Lee, Stewart and Lawrence have looked in detail at post-cholecystectomy abdominal bile collections and their manifestations.7This group are world renowned as international experts in cholecystectomy and complications relating to cholecystectomy. They specifically noted that “Unless drains have been used, a bile leak leads to accumulation of bile in the abdomen. Previous reports have suggested that bile peritonitis, with guarding and rebound tenderness, is the principal manifestation of an abdominal bile collection, but this is actually an uncommon presentation early in the patient’s course. While a fewpatients do have such clinical findings, most have much milder symptoms, best referred to as bile ascites.” This review looked at 179 patients with bile leaks following cholecystectomy of which 154 patients had undrained bile collections and 25 patients had a drain placed at the original operation. It was noted that “Overall, a symptomatic bile collection was initially missed in 77% of patients; their symptoms were considered non-specific or insignificant”. In this series, 42% of patients with significant bile collections greater than 500ml did not have drainage instituted within 7 days of the operation and 19% had not had drainages instituted within 14 days of the original operation. The authors commented that “The symptoms caused by bile collections were often quite subtle. Most patients with bile collections did not present with peritonitis; instead they had bile ascites with mild, relatively non-specific symptoms. Consequently, the presence of a bile collection and associated biliary injury often went unsuspected for a time until symptoms worsened and delays in diagnosis and treatment allowed bile peritonitis and serious illness to develop. Among our series, the correct diagnosis was missed initially in 77% of patients.” Further they comment that “In fact, many of the patients who became seriously ill never passed through a phase that included prominent abdominal pain and tenderness. In short, it was not possible to distinguish those who would become critically ill from those who would not based on the early clinical presentation.” In addition, they commented that “The presence of a drain did not guarantee that a bile collection would be avoided; drains can malfunction.” So, although some experts may suggest that a bile duct injury should be recognised quickly, unless it is actually seen at the time of the original surgery it may go undetected for a relatively prolonged period of time and it would be difficult to prove negligence in relation to delays in detecting the bile duct injury, although once recognised further delays in management can be criticised.
Thomson et al have suggested that patients with biliary injury should be referred urgently to a specialist unit experienced in the management of biliary injury as the success rate of repairs carried out by expert surgeons is superior to those who would carry out such a repair occasionally.8 They pointed out that early repair resulted in a similar outcome to a late repair. This view was supported by Sicklick et al who stated that “Early referral to a tertiary care centre with experienced hepatobiliary surgeons and skilled interventional radiologists would appear to be necessary to ensure optimal results”.9 There is now much compelling data that suggests that if a patient has a bile duct injury recognised then they should be immediately referred to a specialist hepatobiliary surgery centre for revisionary surgery - to delay referral and attempt a repair in a non-specialist unit will usually now be regarded as negligent unless an expert hepatobiliary surgeon has travelled urgently to the unit to offer support during the surgery at the time of injury.
Whilst it is routine practice to convert from a laparoscopic approach to an open surgical approach if there is a significant worry about chances of causing a biliary injury, there is a general reluctance with surgeons to do so as this impacts on the patient in terms of more post-operative pain, prolonged hospitalisation and a prolonged recovery. There is no clear evidence that conversion to an open approach reduces the risk of the injury, although there has been a higher rate of biliary injury noted following the advent of laparoscopic surgery. A reasonable body of general surgeons should suggest that in cases of difficulty during laparoscopic cholecystectomy it is sensible to convert to an open approach in order to lessen the chance of injury or in order to define and repair an injury if it has already occurred. Further, a reasonable body of general surgeons should also argue that if a surgeon recognises an injury as having occurred then it would be normal to convert to an open approach unless the surgeon felt that he could repair the bile duct laparoscopically. In addition, a reasonable body of general surgeons should argue that in a case where the anatomy has not been properly defined then the risks of carrying on with the surgery laparoscopically outweigh risks associated with post-operativemorbidity following on from conversion to open surgery.
The unfortunate minority of patients who sustain laparoscopic cholecystectomy bile duct injuries have a 10-25% incidence of long-term morbidity mainly due to recurrent cholangitis, biliary strictures requiring repeat interventions, and, occasionally, progressive secondary biliary cirrhosis causing end stage liver disease.10 Thus, a major bile duct injury van be a debilitating complication of laparoscopic cholecystectomy that results in significant long-term physical and psychological morbidity.10,11 If an early repair of a bile duct injury is carried out by an experienced hepatobiliary specialist surgical team then the overall outcome in terms of freedom from complications is at the highest level, but there is still a possibility of the development of a late bile duct stricture which carries with it the need for further surgery.8,11 Perera et al have reported that overall, 14% of patients undergoing an early repair of a significant bile duct injury have needed a further intervention: 5% recurrent stricture, 12% cholangitis, 5% needing radiological intervention for stricture dilatation, and 2% requiring further surgery for recurrent stricture. In my own experience, if a patient’s liver function tests are normal and there are no significant symptoms of cholangitis during the first 2 years after surgery then the risk of needing a further intervention (radiological or surgical) is low (less than 5%). Some experts labour the point about a risk for the development of recurrent episodes of cholangitis causing progressive liver disease and the need for a liver transplant. In fact, this risk is very small as only a very few cases have been reported in the medical literature.12, 13 In my experience, it is only patients who experience repeated episodes of symptomatic cholangitis in association with abnormal liver function tests who will develop significant chronic liver disease and the need for a liver transplant, so the life time risk of a need for a liver transplant is considerably less than 1%.
Unfortunately, biliary injury at cholecystectomy can also be complicated by a vascular injury, most commonly an injury to the right hepatic artery. Tzovaras and Dervenis have pointed out that this is an underestimated problem. Although this may contribute to the development of strictures following biliary repair, there is no strong evidence to support a long term negative impact.14 Stewart et al noted that right hepatic arterial injury had no influence on the success of bile duct injury repair in sixty-six cases noted to have a right hepatic artery injury in a series of two hundred and forty-six cases of laparoscopic bile duct injury.15 However, right hepatic arterial injury was more commonly associated with abscess formation, intraoperative bleeding, postoperative bleeding, haemobilia (bleeding into the bile duct), right liver lobe ischaemia (reduced blood supply) and subsequent need for liver resection
If an associated major vascular injury does occur then the outlook can be poor. Buell et al reviewed 49 patients who had sustained significant cholecystectomy-associated vascular injuries.16 Out of 13 patients with arterial injuries, five died. Strasberg and Helton have also reported an extensive review of vascular injury combined with biliary injury in laparoscopic and open cholecystectomy.17 They noted that the most common arterial injury that can occur is injury to the right hepatic artery and that injury to the common hepatic artery is very rare. Of nine patients who suffered an injury to the common hepatic artery, three died and the outcome of two was not known. They commented that the pathogenesis of injuries to the common hepatic artery remains unclear and they suspected that underreporting may occur. This was also true when considering injuries to the portal vein that they felt was much less vulnerable to injury at cholecystectomy than the right hepatic artery. Strasberg and Helton identified 16 cases where the portal vein was injured. Thirteen of these were also associated with injury to a major hepatic artery. Seven out of the 16 patients developed rapid necrosis of the right liver and required an emergency right hemihepatectomy within a few days of cholecystectomy, and three of these patients died from postoperative complications. Another patient required a liver transplant and subsequently died. They felt that it is highly likely that injuries leading to rapid infarction of the liver are under-reported as a result of rapid deterioration and death prior to referral to a tertiary centre. Further, they recognized that there was a general reluctance to report poor outcome so this injury may be more common than is currently thought. Deaths following cholecystectomy are thankfully rare in the UK: the overall rate of inpatient mortality after cholecystectomy is thought to be 0.49%, but only 0.16% for elective cholecystectomy.18 The risk of death is greater in low volume centres that carry out only a small number of cholecystectomies each year.
When a surgeon recognises operative difficulty in laparoscopic cholecystectomy, it is standard teaching to convert to an open approach. Unfortunately, there is little evidence to suggest that conversion to an open approach in a difficult cholecystectomy reduces the risk of biliary or vascular injury or reduces its severity. It is also standard teaching that in a difficult cholecystectomy where accurate definition of anatomy cannot be achieved, there are several possibilities to consider. A fundus first (sometimes called “retrograde”) cholecystectomy can be attempted but this should not be persisted with if anatomy cannot be defined. In that situation, it is reasonable to consider accepting that the whole of the gallbladder cannot be removed and that a sub-total cholecystectomy should be carried out. This involves removing the stones from the gallbladder and removing part of the wall
of the gallbladder and then suturing the cystic duct inside the gallbladder to prevent bile leakage. Another alternative is to abandon the procedure and to refer the patient to a specialist hepatobiliary unit. Unfortunately, once a major injury has occurred during cholecystectomy, recognition of this injury often occurs too late. It is the surgeon’s responsibility to call for help at the appropriate time and a failure to do so should be regarded as negligent.
If a biliary injury occurs during a cholecystectomy operation, the risks of a need for more surgery do not just relate to the bile duct injury. For example, as in any laparoscopic operation, port insertion can cause a bowel injury. Bile leakage and subsequent surgery can lead to the development of abdominal adhesions and there is also a risk of incisional hernia formation. These risks are difficult to quantify but it is my opinion that a reasonable body of general surgeons would suggest that most Claimants would have an approximate 10% risk of the need for a hospital admission for sub acute small bowel obstruction related to adhesions, a 1% risk of a need for surgery for adhesions and a 10% life time risk of the development of an incisional hernia with a need for surgical repair. Almost all patients will develop some abdominal adhesions after any laparotomy and that these can be a significant cause for chronic post-operative pain.19 Many incisional hernias are not detected until more than 5 years after surgery and there is a steady increase in risk year on year, so the fact that a Claimant is showing no signs of incisional hernia formation in the early years following surgery does not mean that they will never develop one.20,21
Another final aspect is to consider who will pursue legal action after a cholecystectomy disaster. In 2010, Perera et al looked at patient perceptions and outcomes in relation to litigation for bile duct injury during cholecystectomy, pointing to adequate consent and communication as major issues.10 Most patients felt they had been inadequately informed prior to surgery and also after the bile duct injury had occurred, and a majority remained "psychologically traumatized" at the time of evaluation. Of 67 patients studied, 22 had started litigation by means of a ‘‘letter of demand’’ or prosecution. Nineteen of the 22 cases had been closed in favour of the Claimant at the time of publication, demonstrating that bile duct injury is difficult to defend. Although there was no significant difference between the awards for a letter of demand versus prosecution cases, the average compensation was £40,800 versus £89,875, respectively. Associated vascular injury, immediate nonspecialist repair, and perceived incomplete recovery following the injury were identified as independent predictors for possible litigation, emphasising the involvement of a specialist hepatobiliary surgeon is essential once an injury has been recognised.
In summary, whilst commonly regarded as routine, cholecystectomy remains an operation that can be fraught with difficulty and danger.
1. Haubrich WS. Calot of the Triangle of Calot. Gastroenterology 2002; 123:1440.
2. McMahon AJ et al. Bile Duct Injury and Bile Leakage in Laparoscopic Cholecystectomy. British Journal of Surgery 1995; 82:307-313.
3. Way LW et al. Causes and Prevention of Laparoscopic Bile Duct Injuries - Analysis of 252 Cases from a Human Factors and Cognitive Psychology Perspective. Annals of Surgery 2003; 237:460-469.
4. Massarweh NN and Flum DR. Role of Intraoperative Cholangiography in Avoiding Bile Duct Injury. Journal of the American College of Surgeons 2007; 2004:656-664.
5.Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg. 1995;180(1):101-25.
6. Wauben LS, Goossens RH, van Eijk DJ, et al. Evaluation of protocol uniformity concerning laparoscopic cholecystectomy in the Netherlands. World J Surg. 2008;32(4):613-20.
7. Lee CM et al. Post Cholecystectomy Abdominal Bile Collections. Archives of Surgery 2000; 135:538-544.
8. Thomson BNJ et al. Early Specialist Repair of Biliary Injury. British Journal of Surgery 2006; 93:216-220.
9. Sicklick JK et al. Surgical Management of Bile Duct Injuries Sustained During Laparoscopic Cholecystectomy Perioperative Results in 200 Patients. Annals of Surgery 2005; 241:786-795
10. Perera MTPR, Silva MA, Shah AJ, Hardstaff R, Bramhall SR, Issac J, Buckels JAC, Mirza DF. Risk factors for litigation following major transection bile duct injury sustained at laparoscopic cholecystectomy. World Journal of Surgery 2010; 34: 2635-2641.
11. Perera MTPR, Silva MA, Hegab BH, Muralidharan V, Bramhall SR, Mayer AD, Buckels JAC, Mirza DF. Specialist early and immediate repair of post-laparoscopic cholecystectomy bile duct injuries is associated with an improved long-term outcome. Annals of Surgery 2011; 253: 553-560.
12. De Santibanes E et al. Liver transplantation for the sequelae of intra-operative bile duct injury. HPB 2002; 4: 111-115.
13. Oncel D et al. Bile duct injury during cholecystectomy requiring delayed liver transplantation: a case report and literature review. Journal of Experimental Medicine 200; 209: 355-359
14. Tzovaras G and Dervenis C. Vascular Injuries in Laparoscopic Cholecystectomy - An Underestimated Problem. Digestive Surgery 2006; 23:370-374.
15. Stewart L et al. Right Hepatic Artery Injury Associated with Laparoscopic Bile Duct Injuries - Incidence, Mechanism and Consequences. The Society for Surgery of the Elementary Tract (SSAT) Abstracts 2003, Abstract ID 100938.
16. Buell JF, Cronin DC, Funaki B, et al. Devastating and fatal complications associated with combined vascular and bile duct injuries during cholecystectomy. Arch Surg. 2002;137:703-10.
17. Strasberg SM, Helton WS. An analytical review of vasculobiliary injury in laparoscopic and open cholecystectomy. HPB. 2011;13:1-14.
18. Harrison EM, O’Neill S, Meurs TS, et al. Hospital volume and patient outcomes after cholecystectomy in Scotland — Retrospective National Population Based Study. Br Med J. 2012;344:1-14.
19. Van Goor H. Consequences and complications of peritoneal adhesions. Colorectal Diseases 2007; 9 (Suppl 2): 2534.
20. Mudge M, Hughes L. Incisional hernia: a 10 year prospective study of incidence and attitudes. British Journal of Surgery 1985: 72: 70-71.
21. Itatsu K et al. Incidence of and risk factors for incisional hernia after abdominal surgery. British Journal of Surgery 2014; 101: 1439-1447.