INTRODUCTION — In the late 1980s after the first successful laparoscopic cholecystectomy in Europe, this revolutionary minimally invasive surgery rapidly became the accepted technique for the treatment of gallbladder disease in the United States. The rapid acceptance of this new technique by the medical profession and the public was related to the obvious advantages of reduced cost, decreased hospital length of stay, and increased patient satisfaction.

Few clinical studies were performed to compare this new procedure to standard open cholecystectomy. As laparoscopic cholecystectomy gained wider acceptance, complications that were rarely seen with open cholecystectomy, such as bile duct injury, were reported in as many as 5 percent of patients [1]. At present, approximately 750,000 laparoscopic cholecystectomies are performed annually in the United States (accounting for roughly 90 percent of all cholecystectomies) with an overall serious complication rate that remains higher than that seen in open cholecystectomy, despite increasing experience with the procedure [2,3]. The complication rate of open cholecystectomy has increased as well due to the overall declining experience in open surgery, as this approach is now reserved for the most complicated and challenging cases [4].

This topic review will discuss complications that are specifically related to or more commonly encountered with the laparoscopic procedure. The management of acute cholecystitis, indications and surgical techniques for laparoscopic cholecystectomy, common bile duct exploration, and repair of common bile duct injuries are discussed elsewhere in detail. (See "Treatment of acute calculous cholecystitis" and "Laparoscopic cholecystectomy" and "Endoscopic management of complications from laparoscopic cholecystectomy" and "Surgical common bile duct exploration" and "Repair of common bile duct injuries".)

Other adverse outcomes, such as retained common bile duct stones (incidence of around 10 percent), postcholecystectomy syndromes, and misdiagnoses (sphincter of Oddi dysfunction) occur with the same frequency with both laparoscopic and open cholecystectomy and will not be discussed here. (See "Choledocholithiasis: Clinical manifestations, diagnosis, and management" and "Clinical manifestations and diagnosis of sphincter of Oddi dysfunction" and "Laparoscopic cholecystectomy", section on 'Postcholecystectomy syndrome'.)

COMPLICATIONS OF LAPAROSCOPIC APPROACH — Serious complications that occur with laparoscopic cholecystectomy, including bile duct injury, bile leaks, bleeding, and bowel injury, result in part from patient selection, surgical inexperience, and the technical constraints that are inherent to the minimally invasive approach [3,5-9]. A major mode of ductal injury is diathermy burns, which may initially go unnoticed and usually involve the right or common hepatic ducts. These factors, as well as intrinsic sequelae of biliary tract diseases, such as inflammation and scarring, have led to the concept of "Stop Rules" for surgeons performing this operation. In essence, if a safe dissection cannot be ensured laparoscopically, early conversion to an open approach should be readily accepted as the proper course [10,11].

In a study that combined the data from seven large studies with a total of 8856 laparoscopic cholecystectomies, serious complications occurred in 2.6 percent [12]. A combined review of eight large studies of laparoscopic cholecystectomies reported the following types and frequencies of major complications: bleeding (0.11 to 1.97 percent), abscess (0.14 to 0.3 percent), bile leak (0.3 to 0.9 percent), biliary injury (0.26 to 0.6 percent), and bowel injury (0.14 to 0.35 percent) [13]. The rate of wound infections and surgical site infections is lower with the laparoscopic approach than with the open approach, but there is no advantage in terms of intra-abdominal abscess formation [14].

Surgeon experience — The overall incidence of laparoscopic complications is also related to the experience of the surgeon. A report of over 8800 procedures performed by 55 surgeons estimated that 90 percent of bile duct injuries occurred in the first 30 cases for each surgeon, with the incidence falling from 1.7 percent in the first case to 0.17 percent at the 50^th case [15]. The incidence of bile duct injury appears to have stabilized at 0.4 to 0.6 percent in other series, which is four times higher than that of open cholecystectomy [16-21]. Early experience with more advanced minimally invasive techniques (eg, single-incision laparoscopic surgery) suggests higher bile duct injury rates compared with conventional laparoscopic cholecystectomy [22].

Surgeons with more experience have the lowest complication rates [19]. Furthermore, credentialing for laparoscopic surgery is now becoming a reality. Many institutions currently, or soon, will require proof of a fundamental skill set in basic laparoscopy for credentialing purposes. To this end, the American College of Surgeons and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) have developed a validated assessment tool named Fundamentals in Laparoscopic Surgery (FLS) [23,24]. FLS is now required by the American Board of Surgery to qualify for the surgical certification examination.

Patient selection — Patient selection is also an important determinant of risk. Serious complications are more likely in patients who have acute cholecystitis with active inflammation or chronic cholecystitis with fibrosis of the gallbladder fossa or porta hepatis. We do not currently recommend routine preoperative endoscopic retrograde cholangiopancreatography (ERCP) or perioperative cholangiography unless there is a high suspicion of common duct stones, although the necessity of intraoperative cholangiography continues to be the subject of some controversy. Clinical indicators of risk for choledocholithiasis include initial liver function tests that are elevated, evidence of bile duct dilatation, persistent jaundice, evidence of pancreatitis, or active features of cholangitis. (See "Acute cholangitis: Clinical manifestations, diagnosis, and management".)

BILIARY INJURY CLASSIFICATION — A classification of biliary injuries is outlined in the figure (figure 1) [12]. The clinical presentation of the various injuries varies from asymptomatic bile leak that resolves spontaneously to complete obstruction of the extrahepatic biliary tree, which will present acutely within days. On the other hand, segmental biliary tree obstruction may not present for several years after the procedure.

Type A — These are injuries that involve leakage into the gallbladder bed from either the minor hepatic ducts or the cystic duct, with no loss in continuity of the biliary tree.

Type B and C — These are occlusion (type B) and transection (type C) injuries of aberrant right hepatic ducts. These are associated with cystic duct drainage into an aberrant right hepatic duct, an abnormality seen in as many as 2 percent of patients. In this setting, the right hepatic duct can be mistaken for the cystic duct at the point of insertion into either the main hepatic duct or common bile duct.

When the injury to the duct is an occlusion (type B), the patient may remain asymptomatic for years and then present with right upper quadrant pain, and fever due to recurrent cholangitis and segmental fibrosis and/or atrophy may result. In comparison, a biliary leak occurs when the duct is transected but not occluded (type C). Concomitant injuries to the right hepatic artery are frequently associated with this particular problem.

Type D — These are injuries with lateral damage to the common bile duct resulting in a biliary leak; they can usually be managed endoscopically but may progress to the more serious type E injury. (See "Endoscopic management of complications from laparoscopic cholecystectomy".)

Type E — Type E injuries involve the main ducts and are classified according to the level of injury in the biliary tree (Bismuth classification) (figure 1).

●E1 (Bismuth type I) – Transection >2 cm from the confluence

●E2 (Bismuth type II) – Transection <2 cm from the confluence

●E3 (Bismuth type III) – Transection in the hilum

●E4 (Bismuth type IV) – Separation of major ducts in the hilum

●E5 (Bismuth type V) – Type C injury plus injury in the hilum

Affected patients typically present with jaundice weeks to years after cholecystectomy [25]. Surgical repair via a hepaticojejunostomy is almost always required.

DIAGNOSIS AND MANAGEMENT OF BILIARY INJURIES — Biliary injury may be recognized at the time of laparoscopic surgery; if so, conversion to an open procedure and repair of the injury should be attempted only if the surgeon is comfortable with advanced biliary surgery. If not, the surgeon should obtain intraoperative consultation with a specialist who is skilled in this problem [26,27].

External drainage of the gallbladder fossa should be achieved prior to referral to a specialist. Repair of biliary duct injuries should always be approached by an experienced multidisciplinary team consisting of a surgeon, diagnostic radiologist, interventional gastroenterologist, and interventional radiologist.

Recognition of biliary injury may be more likely if routine intraoperative cholangiography is performed [26,27]. However, the value of this approach is controversial [28]. Some studies found no overall benefit of routine intraoperative cholangiography, which, it was suggested, should be limited to patients suspected of having a common bile duct stone (which is managed by endoscopic retrograde cholangiopancreatography [ERCP]) or if biliary anatomy is unclear [28]. This is discussed in detail elsewhere. (See "Surgical common bile duct exploration", section on 'Intraoperative cholangiography'.)

Most injuries are not recognized at the time of initial surgery. Early presentation of bile duct injury after laparoscopic cholecystectomy is generally nonspecific, with patient complaints of vague abdominal pain, persistent nausea and vomiting, and low-grade fever [29].

Biliary and cystic duct leaks — Biliary and cystic duct leaks represent type A, C, and D injuries. Small perihepatic fluid collections are seen in approximately one-half of patients who have ultrasound (US) examination within 24 hours of laparoscopic surgery. These are asymptomatic, are of no clinical significance, resolve spontaneously, and are due to the normal process of the operation. The number of these fluid collections that actually contain bile is not known.

Major biliary leakage is usually seen 2 to 10 days postcholecystectomy. Affected patients typically present with fever, abdominal pain, and/or bilious ascites. Jaundice is usually mild. Leukocytosis and abnormal liver function tests, particularly elevations in serum alkaline phosphatase and gamma-glutamyl transferase, are common. Bilirubin will be mildly elevated as the body reabsorbs third-spaced bile.

Type A — Leakage of bile that is not related to injury of the main bile ducts arises from the cystic duct remnant or the bile ducts of Luschka [30]. Leakage from the cystic duct remnant can result from laceration of a small cystic duct, dislodgement of one of the clips or ligatures on the cystic duct, ductal necrosis as a result of cholecystitis, or a distal obstruction in the common duct by a stone with resultant blowout of the cystic duct remnant (image 1).

The bile ducts of Luschka conceptually include both small ducts that distinctly enter the gallbladder bed or small tributaries of minor intrahepatic radicals of the right hepatic ductal system (image 2). Although true ducts of Luschka cannot be avoided, injury to these tributaries is probably caused by dissection into the liver parenchyma. Regardless of origin, both can continue to leak after removal of the gallbladder. Clinically significant leakage from the ducts is rare.

Types C and D — These injuries involve both a biliary leak and injury to the main or aberrant ducts.

Radiologic workup — Upon presentation, we initially perform transabdominal US to define the extent of the possible bile leak. Bile leaks can present as contained, loculated collections in the gallbladder fossa (image 3) or around the liver or as frank, diffuse biliary peritonitis. Ultrasonography can also determine if the intrahepatic ducts are dilated (and at what specific level), suggesting common duct obstruction. If necessary, better definition can be obtained by computed tomography (CT) scan (image 4), which is very sensitive in detecting intraperitoneal or pelvic free fluid.

Large loculated collections may need to be percutaneously drained by a radiologist using CT or US guidance with a catheter left in place for ongoing drainage (image 5) [31,32]. Bilious fluid is highly suggestive of a bile leak.

After the demonstration of fluid in the peritoneum, we obtain a hepatobiliary iminodiacetic acid scan (HIDA) scan to delineate leakage of radiotracer into the peritoneal cavity and confirm that the fluid is bile. Biliary scintigraphy cannot anatomically localize the site of injury but is diagnostic of an ongoing bile leak in virtually all patients [33]. Early films are useful for major leaks (image 6), but delayed films approximately three hours after injection of tracer should be obtained if the early scans are negative (image 7). If the HIDA scan confirms an active bile leak, determination of the site of the leak is usually made by ERCP (image 8).

Magnetic resonance cholangiopancreatography (MRCP) is an alternative way of assessing the bile ducts [13]. MRCP offers a noninvasive method of diagnosing a bile leak, identifying the source of the leak, and identifying tiny stones left in the bile duct, although it does not allow direct intervention as is possible with ERCP. MRCP can be particularly useful for complete imaging of the biliary tree (image 9A-B) [34]. This is especially important in cases of hilar injury such as a right posterior segmental duct transection or obstruction, where identification via ERCP may not be as thorough. MRCP techniques allow for precision in identification of the injury site because the contrast agents are excreted in the bile [35,36]. This can be useful for distinguishing leaks from the gallbladder fossa dissection bed from those of cystic duct origin. The modality (ERCP versus MRCP) chosen for investigation depends on the suspected injury pattern as well as local expertise in or availability of techniques.

Almost all type A and D injuries can be managed by insertion of a biliary stent across the ampulla at the time of the ERCP to decrease pressure in the proximal biliary system (image 10) [37-39]. As an alternative, a sphincterotomy can be performed to promote free flow of bile across the ampulla without stent insertion. We favor the former approach and perform sphincterotomy only if there is common bile duct obstruction secondary to choledocholithiasis. Stenting results in a rapid decrease in the drainage of bile through the percutaneous drains, which can often be removed in three to five days. (See "Endoscopic management of complications from laparoscopic cholecystectomy".)

There are certain cases where, despite these minimally invasive therapeutic maneuvers, the patient continues to have severe abdominal pain from bile peritonitis or evidence of progressive intra-abdominal sepsis. In such cases, operative exploration and washout (achieved by either open or laparoscopic means) is important and effective.

Management after diagnosis — Subsequent management varies with the type of injury:

●In type A injuries, the stent can be removed endoscopically at two weeks if the patient is asymptomatic, the liver function tests are normal, and there is no ongoing leak at the follow-up ERCP.

●In type C and D injuries, a repeat HIDA scan is performed two to four weeks after stent insertion. If there is no leak, the stent can be removed endoscopically at repeat ERCP. If there is a minor leak at the time of stent removal, we usually either perform a sphincterotomy to facilitate bile flow into the duodenum or replace the stent for a further four weeks. The success of endoscopic treatment of type D injuries is dependent on the degree of bile duct injury. Many type D injuries with lesser degrees of damage can be effectively managed in the short term by stenting. However, close clinical follow-up with repeated diagnostic ERCP or MRCP may be necessary as these patients are at risk for developing late type E injuries due to stricture development from either the progressive effects of diathermy injury or the natural healing process. Injuries encompassing a larger circumference usually cannot be treated successfully by stenting alone and will require operative intervention. Total endoscopic management of type C injuries is less successful because by definition, a segment of biliary drainage from the liver is "disconnected" from its natural flow into the distal biliary tree.

Occlusive injury to the right hepatic duct (type B injury) — Occlusive injury to the right hepatic duct is usually an occult injury that results in a segmental cholestasis in the liver and, after many years, atrophy of the right lobe. Some of these patients develop cholangitis secondary to infection or even intrahepatic stone disease. Symptomatic patients present with pain and features of cholangitis. (See "Acute cholangitis: Clinical manifestations, diagnosis, and management".)

The diagnosis is usually made by ERCP, which shows an absent segmental hepatic duct on the right side, or by MRCP, which shows an obstructed segment lacking continuity with the distal biliary tree. CT scan may show focal atrophy or cystic dilation, and a percutaneous cholangiogram may be necessary to show ductal obstruction and overall biliary anatomy. Treatment is surgical, involving preferably a hepaticojejunostomy; segmental resection of the affected lobes may also be necessary if atrophy is significant.

Injuries to common bile or common hepatic ducts (type E injury) — Injuries to common bile or common hepatic ducts are the most serious and are similar to the injury most commonly seen with open cholecystectomy. The clinical manifestations of these injuries are highly variable, depending upon whether the main duct is completely transected or clipped with no leakage of bile. If a bile leak occurs, it is often recognized at the time of the laparoscopic cholecystectomy, and if limited in scope, a surgical repair can be attempted by T-tube drainage of the common bile duct at the site of the injury. Primary repair of the bile duct should be avoided because of its high propensity for breakdown or stricture formation in the setting of a normal caliber common bile duct. In cases of more significant damage to the duct, a hepaticojejunostomy is preferable. (See "Repair of common bile duct injuries".)

Most patients present with jaundice weeks to years after surgery, and US shows dilated intrahepatic ducts. ERCP is usually performed, revealing complete obstruction in the extrahepatic biliary tree with no filling of intrahepatic ducts.

The next procedure should be percutaneous transhepatic cholangiography to delineate the intrahepatic ducts and the length of the stricture. Since the biliary system is completely occluded, a drainage procedure of both hepatic lobes should be performed to decompress the liver and reduce the risk of cholangitis [39]. This is usually achieved by insertion of large percutaneous stents into both the left and right hepatic ducts. These stents facilitate identification of the ducts during subsequent operation. (See "Percutaneous transhepatic cholangiography".)

In occasional patients, a stricture or partially occlusive surgical clip will be responsive to dilation and stent insertion. With favorable results in limited series, dilation and stent insertion is being adopted more often as a less invasive, first-line approach to this problem. In this setting, a combined percutaneous transhepatic cholangiography and ERCP technique can be used to treat the occlusion with good long-term results. However, most strictures that are of high grade and over 1 cm in length are not good candidates for endoscopic therapy. Thus, once the liver has decompressed, a hepaticojejunostomy is usually the treatment of choice, using the indwelling stents as a guide to identification of the ducts [40]. (See "Endoscopic management of complications from laparoscopic cholecystectomy" and "Repair of common bile duct injuries".)

There is a significant surgical mortality (5 percent), and restenosis rates vary from 5 to 28 percent [41]. Factors such as advanced age and comorbid illness are important, but the most important prognostic factor is whether secondary biliary cirrhosis has developed. Patients with this complication may be best treated by hepatic transplantation. (See "Liver transplantation in adults: Patient selection and pretransplantation evaluation".)

BLEEDING COMPLICATIONS — The incidence of uncontrollable bleeding from laparoscopic cholecystectomy is 0.1 to 1.9 percent and can occur from three distinct sites – the liver, arterial sources, or port insertion sites.

Significant bleeding from the liver bed is fairly common and is now appreciated to be from the often close proximity of the middle hepatic vein and its radicals to the gallbladder fossa in up to 10 to 15 percent of patients [42]. Bleeding usually occurs during the final aspects of the removal of the gallbladder from the hepatic fossa and generally requires immediate conversion to open to control profuse hemorrhage through stitch ligation, if initial attempts at laparoscopic hemostatic control fail.

Arterial control issues involving the cystic artery can be identified immediately and controlled with clips (only if anatomical landmarks can be safely ensured, or else there is a high association with right hepatic arterial injury). They may also first be evident postoperatively as an acute hemodynamic decline requiring resuscitation, transfusions, and often reoperation. The culprit is usually a dislodged clip in this scenario.

Finally, incision or trocar sites can bleed. Patients usually present subacutely during the first postoperative days. We advocate direct visualization of trocar removal at the end of the laparoscopy so that such a problem can be addressed with laparoscopically placed sutures if necessary. When patients present with delayed bleeding, the diagnosis of hematoma can be made with visualization of a heterogeneous fluid collection on ultrasound (US) examination. If US examination is not diagnostic, abdominal wall and intraperitoneal hematomas can be visualized on computed tomography as areas of higher attenuation [13]. If the patient is hemodynamically unstable, direct evaluation by re-laparoscopy is advocated.

BOWEL INJURY — Inadvertent bowel injury has been described in approximately one to four cases in 1000 laparoscopic procedures in various reports [9,41,43]. Management of this complication is dictated by the clinical scenario.

If the injury is noted at the time of surgery, then conversion to an open procedure for repair is indicated if it cannot be repaired through the laparoscope.

Patients may present with trocar site pain, abdominal distention, diarrhea, leukopenia, and cardiovascular collapse from sepsis, typically within 96 hours of the procedure [43]. If the patient is septic or has free air, then an emergency laparotomy is indicated.

In cases where the presentation is more indolent and controlled, standard enterocutaneous fistula management with nutritional support and adequate drainage and wound care is appropriate.

POSTCHOLECYSTECTOMY SYNDROME — Postcholecystectomy syndrome (PCS) is a complex of heterogeneous symptoms including persistent abdominal pain and dyspepsia that recur and persist after cholecystectomy. This is presented in detail elsewhere. (See "Laparoscopic cholecystectomy", section on 'Postcholecystectomy syndrome'.)

QUALITY OF LIFE AFTER BILE DUCT INJURY — The occurrence of a bile duct injury incurs a significant burden on patients and surgeons alike.

Evidence, including a meta-analysis, indicates that, for patients, mental domains of quality of life (QOL) are more often negatively influenced than are physical domains [44]. In a registry-based study of over 710,000 cholecystectomies performed between 2005 and 2014, bile leaks occurred in 3551 patients (0.50 percent) and were managed almost exclusively endoscopically [45]. Bile duct injuries occurred in 1584 patients (0.22 percent) with 84 percent managed surgically. Patients with a bile leak were more likely to die at one year (2.4 versus 1.4 percent; odds ratio 1.85; p <0.001). Similarly, patients with a bile duct injury had an increased one-year mortality (7.2 versus 1.3 percent; odds ratio 2.04; p <0.0001).

For surgeons, bile duct injury remains one of the most litigious events in general surgery [46,47].

INJURY PREVENTION — The "critical view of safety" is a surgical technique designed to help the surgeon avoid bile duct injury. Using this approach, Calot's triangle is dissected free of all tissue except for the cystic duct and artery, and the base of the liver bed is exposed (figure 2). When this view is achieved, the two structures emanating from the gallbladder (cystic duct and cystic artery) and the interface with the liver at the base of the gallbladder fossa (cystic plate) should be definitively identified [12]. This is optimally achieved by obtaining a "doublet" view of both the anterior and posterior aspects of Calot's triangle [48,49]. Adequate documentation of safety maneuvers is strongly encouraged [50,51]. (See "Laparoscopic cholecystectomy", section on 'Critical view of safety'.)

Difficulty with identification of the critical view should lead the surgeon to consider performing cholangiography or converting the laparoscopic cholecystectomy into an open procedure. This technique was employed in a study of 1046 consecutive patients who underwent laparoscopic cholecystectomy from 2002 to 2007, with no bile duct injury [52].

SOCIETY GUIDELINE LINKS — Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Gallbladder surgery" and "Society guideline links: Laparoscopic and robotic surgery".)

SUMMARY AND RECOMMENDATIONS

●Serious complications of laparoscopic cholecystectomy, including bile duct injury, bile leaks, bleeding, and bowel injury, result in part from patient selection, inherent patient disease, surgical inexperience, and the technical constraints of the minimally invasive approach. (See 'Complications of laparoscopic approach' above.)

●Early conversion to an open cholecystectomy should be readily accepted as the proper course if a safe dissection cannot be ensured laparoscopically. (See 'Complications of laparoscopic approach' above.)

●Repair of biliary duct injuries should always be approached by an experienced multidisciplinary team consisting of a surgeon skilled in advanced biliary surgery, diagnostic radiologist, interventional gastroenterologist, and interventional radiologist. External drainage of the gallbladder fossa should be achieved prior to referral to a specialist. (See 'Diagnosis and management of biliary injuries' above.)

●Biliary leakage should be suspected when patients present after cholecystectomy with fever, abdominal pain, and/or bilious ascites. Large loculated collections should be percutaneously drained with radiologic guidance and a catheter left in place for continuing drainage. Endoscopic retrograde cholangiopancreatography (ERCP) may define the leak and allow stent placement. (See 'Diagnosis and management of biliary injuries' above.)

●If a patient with a bile leak continues to have severe abdominal pain from bile peritonitis or evidence of progressive intra-abdominal sepsis, operative exploration and washout is indicated. (See 'Diagnosis and management of biliary injuries' above.)

●Occlusive injury to the right hepatic duct results in a segmental cholestasis and ultimately atrophy of the right lobe. The occlusion is corrected with a hepaticojejunostomy; segmental resection of the affected lobes may also be necessary if atrophy is significant. (See 'Diagnosis and management of biliary injuries' above.)

●Limited injuries to common bile or common hepatic ducts that are recognized at the time of surgery can be repaired by T-tube drainage of the common bile duct. Primary repair of the bile duct should be avoided because of the high rates of breakdown or stricture formation. In cases of more significant damage to the duct, a hepaticojejunostomy will be required. (See 'Diagnosis and management of biliary injuries' above.)

●Delayed presentation of common bile or common hepatic duct injuries requires decompression of the liver with percutaneous stents to reduce the risk of cholangitis and define the injury. Although some patients can be treated with dilation and stent insertion, most will require a hepaticojejunostomy. (See 'Diagnosis and management of biliary injuries' above.)

●Bleeding can occur from the liver, arterial sources, or port insertion sites. (See 'Bleeding complications' above.)

●Surgical technique that emphasizes the "critical view of safety" will help avoid bile duct injury. (See 'Injury prevention' above.)