JDDH Journal

Introduction

Bile duct leak is an infrequent but serious disorder. The cause of bile duct leak can be either iatrogenic or more rarely, traumatic. [1] The great majority (95%) occurs after hepatobiliary surgery and the most common cause is related to open and laparoscopic cholecystectomy.[2] Biliary injury occur in 0.1 - 0.2 % and 0.3 - 0.8 % after open and laparoscopic cholecystectomy respectively.[3]

Postoperative bile leak is usually the result of oblivious injury to the bile ducts, inappropriate ligation of the cystic duct stump, or leakage from the liver bed or the drainage site and usually precipitated with a distal block from residual stones or strictures. [4] Minor leakage may stop spontaneously while major leakage may be a serious problem to the patient. [5] These patients present with external or internal biliary leakage resulting in localized or generalized biliary peritonitis. [6] 11-23% of biliary injuries are diagnosed intraoperatively while the remaining is diagnosed postoperatively or after discharge. [7]

Early management in a specialized center is the cornerstone for satisfactory results. Inadequate management usually results in serious co-morbidities and a more difficult repair.[8]Surgery is the best method for the treatment, but it is associated with serious complications and great mortality.[9]

Preoperative management ranges from simple drainage and early transfer up to bilio-enteric anastomosis.[10] Minimally invasive endoscopic procedure with evidenced results equal to surgical outcomes became the treatment of choice.[9,11] As compared to surgery, endoscopic treatment may require many sessions, and is not effective in all cases.[12]

What is the best management (surgical versus endoscopic) of postoperative bile leak still the major challenging facing surgeons and this work presents the experience of four major tertiary referral centers in Egypt trying to answer this question.

Patients and Methods

155 patients suffering from postoperative bile leak referred to our centers during the period from January 2014 to October 2016, was enrolled in this study. We exclude patients with bile leak from trauma, rupture, associated biliary malignancy or vascular injury. History, clinical examination, and routine investigations (complete blood count, liver function tests, coagulation parameters and ultrasonography) were done for all patients. Computed tomography (CT) or magnetic resonance imaging (MRI) was done in some selected cases. Bile leak was diagnosed clinically (abdominal pain, fever, distension, nausea, tenderness, jaundice) and radiologically (US and/or CT scan) and was re-confirmed by cholangiogram.[9]

Patients were classified simply according to cholangiographic and operative findings into two groups; simple bile leak (liver bed leak, cystic duct leak, accessory duct leak, and leak with partial laceration of the ductal system) and complex bile leak (duct transection, retained stone, stricture or anastomotic leak). Patients were managed gradually, starting with the minimally invasive (endoscopic treatment alone or with percutaneous technique) to the more invasive surgical technique. Some patients underwent a combination of these procedures. The study protocol was approved by the ethical committee of our hospitals. Also, a written informed consent was obtained from all the patients.

In cases with planned ERCP, when a considerable localized collection was defined, a radiologically guided drainage was done, while when the collection was large and diffuse, open or laparoscopic drainage was done, either before or after the procedure. For simple bile leak, patients underwent combined endoscopic sphincterotomy (ES) plus plastic stent (10F, 9-12 cm), straddling the site of the leak. For patients with bile leak and retained stones, a sphincterotomy, stone removal, and stent insertion was done. For patients with bile leak and duct stricture, dilatation and a plastic stent(s) was done. Repeat ERCP for assessment and stent removal was performed 2-3 months after improvement. Cholangiography was performed to confirm healing and absence of stricture or residual stones and they were managed accordingly. The percutaneous intervention was done in cases of failure of ERCP either in the form of percutaneous transhepatic drainage (PTC) prior surgery or a part of combined procedures (Rendezvous technique). Surgery was done either urgently (large and diffuse collection not suitable for percutaneous drainage) or electively (after failed or inappropriate nonsurgical tools treatment).

Follow up

Third generation cephalosporin antibiotics were given for all patients. Patients were discharged from the hospital with clinical and radiological improvement and they were followed up in the out-patient clinic.

Main outcome measurements

Successful management was defined by clinical and investigatory improvement and normal ERCP with stent removal with no further complications.

Statistical analysis

Statistical analysis was made using the Statistical Package for Social Sciences (SPSS) version 16.Descriptive data are expressed as mean - standard deviation or medians and ranges for continuous variables and as number and percent for categorical variables.

Results

From January 2014 to October 2016, 155 cases of postoperative bile leak were incorporated in this study. There were 70 male and 85 female. 21 cases (13.5%) were previously operated in our centers. The median time for the referral to our hospitals was 8 days (2-87 days) after the first operation. During this period 18 patients (11.6%) underwent one or more subsequent endoscopy or laparotomy. The amount of bile leak ranged from 100-880 ml/day,and the commonest site (56.1%) of external bile follow was the abdominal drain. 149 cases were diagnosed by cholangiogram while the remaining 6 cases were operated urgently without a cholangiogram. Patient’s demographic data were shown in table 1.

Management

18 patients were initially treated before referral either endoscopically (3 cases) or surgically (15 cases). The definitive management was done within 0-143 days (median 8 days) after the injury. Treatment was done either by ERCP alone or in combination with the percutaneous technique in some cases or surgically (Table 2).

93 patients were subjected firstly to endoscopic treatment. Successful management was achievable in 89 cases (3 cases assisted with the percutaneous route) and failure to control the leak after a reasonable time occurred in 4 patients where they managed surgically. The last case was subjected firstly to urgent surgery due to biliary peritonitis.

Endoscopic treatment exhibited a 94.7% success rate. The leak was controlled in all patients in a mean period of 3.7 (range 1-19) days. The number of ERCP sessions: mean 1.1 (range 1-3). Percutaneous drainage of bile collections was performed in 11 patients (before ERCP in 8 patients, after ERCP in 3 patients).

Complex bile leak (61 patients)

27 cases (44.2%) were managed endoscopically while 34 patients (55.8%) were managed surgically.

Bile leak with complete transection of the bile ducts (12 patients)

These patients managed surgically (2 cases urgently and 10 cases electively) with Roux-en-Y hepatico-jejunostomy and choledocho-duodenostomy as a reconstructive repair. Bile collections was initially drained percutaneously (2 cases) or surgically (2 cases), to stabilize the patient's condition in cases with removed or slipped drain.

Bile leak with stone (33 patients)

From 28 patients who were subjected firstly to ERCP, 20 patients were managed definitively with ES, stone extraction, and biliary stent while the remaining 8 cases were managed initially with ES and biliary stent due to intra-hepatic stones, or hugely dilated CBD requiring drainage. After cessation of bile leak, these patients were treated definitively with reconstructive surgery. The other 5 cases were managed firstly by urgent surgery due to biliary peritonitis in the form of choledocholithotomy and repair over T-tube (4 cases) and peritoneal drainage followed by elective HJ (1 case). 

The number of ERCP sessions: mean 1.6 (range 1-3). Percutaneous drainage of bile collections was performed in 3 patients (before ERCP in 2 patients, after ERCP in 1 patient).

Bile leak with stricture (12 cases)

11 patients were subjected firstly to ERCP. Endoscopic treatment was successful in 7 cases (1 cases assisted with percutaneous rout), and 4 cases were failed dilatation to enough size (8 Fr). They were managed with percutaneous trans-hepatic drainage and elective surgical treatment in the form of HJ after 2-3 months. The last case was managed urgently by drainage followed by elective HJ.

Drainage of bile collections was performed in 3 patients, all before (2 patients) or during initial treatment (1 patient). The number of ERCP procedures: mean 2.7 (range 1-5).

Anastomotic leak (4 cases)

They were treated with redo the anastomosis (HJ), 1 cases urgently and 3 cases electively after drainage (percutaneous = 1 case, surgical = 2 cases).

Surgical treatment for bile leak (Tables 3&4)

Definitive surgical treatment was done within 36 days (range 1-98) from injury in 39 patients with 46 surgical procedures.

Complications

The median follow-up was 11.5 months (range, 0-30 months). 40 patients (25.8%) showed, at least, one postoperative complication (range 1-3). Complications were classified according to the Dindo classification system.[13] Short-term complications occurred in 13 patients (11.2%) with the endoscopic treatment and in 15 patients (38%) with the surgical maneuver, while long-term complications developed in 6 patients (5.2 %) with the endoscopic maneuver, and in 6 patients (15.4%) with the surgical maneuver. The mortality rate was 0.9% (1 patient), one patient in the endoscopic group (0.4%), and 2patients in the surgical group (5.1%), (Tables 5&6).

Treatment outcomes

The mean time from diagnosis to cure was 5.6 ±3 days (range 4-17 days) in the endoscopic group and 66 ±35 days (range 7-105 days) in the surgical group (Table 7).

Discussion

The incidence of postoperative bile leak cannot be assessed accurately as many cases may heal spontaneously.[14]Postoperative bile leak usually occurs from the liver bed or bile duct injury,[15] as a result of pressure gradient created by the sphincter of Oddi.[16] The commonest cause of postoperative bile leak was post-cholecystectomy and the commonest site was the cystic duct stump, and this was comparable with the previously published results.[17] Cholangiogram was the standard method of the diagnosis in most cases, however, the leak was minimal and not evident in 5 cases, such cases may heal spontaneously according to the literature.[18]Treatment options available for bile leak include surgical repair, percutaneous biliary drainage, and endoscopic biliary drainage.[10] It is important to select the appropriate therapeutic approaches according to the setting. Resorting to surgery as a primary approach for therapy should not be the standard practice. On the other hand, strict adherence to a conservative approach, which employs non-surgical methods and excludes surgery, is associated with an obligatory 9% conversion to surgery at an advanced stage of the disease, together with a mortality rate of 3.5%.[19]Surgery may be required for 2 goals: 1) drainage of collections in uncontrolled fistulas, and 2) definitive treatment. Two reasons place drainage as an early essential step: Firstly, an intra-abdominal collection may predispose to serious septic complications unless promptly drained and secondly, final repair should not be attempted at this early stage, since the affected bile duct(s) are collapsed, friable and are usually embedded within a severe local inflammatory reaction. As a definitive therapy, surgery is indicated when: 1) there is no bilio-enteric continuity, 2) failure of non-surgical methods with bilio-enteric continuity, and 3) surgery is the primary line of treatment for an associated pathology, e.g. malignancy.[20]Earlier, bile leak has been treated by surgical repair, and it is associated with high morbidity (22-37%) and mortality (3-18%).[17]Also percutaneous trans hepatic biliary drainage carries a high morbidity rate owing to hemorrhage and bile leak related to liver puncture.[21]

Endoscopic therapy became the standard method for definitive treatment of postoperative bile leak,[22]in the form of nasobiliary drainage (NBD), sphincterotomy, or stent insertion,[23,24] with no consensus regarding optimal endoscopic intervention.[23-27] The principle of endoscopic techniques is the abolition or reduction of the pressure gradient and bile diversion away from the site of injury, resulting in the closure of the fistula.[28]

We follow the policy of crossing the stent above the site of the leak with the conflicting results [29,30] regarding the strategy of stent insertion, There are no evidenced data regarding the optimal number, diameter, shape, type and length of stent necessary for optimal treatment of postoperative bile leak.[31-33] we did not use NBD because of patient’s discomfort and this agrees with many papers.[29]

In cases with simple bile leak, endoscopic treatment was very effective in the treatment of 94.7% of patients though 11.7% required combined external drainage and these results were comparable with those published by many authors.[34-36] We can say that endoscopic treatment replaced surgery in all simple bile leak cases as a competitive definitive treatment.

In cases with complex bile leak, endoscopic treatment was less effective in comparison to surgical treatment (44.2% vs. 55.8%). Although, endoscopic treatment proved effective in 70 % and 58.3 % of cases with bile leak associated with retained stone or stricture respectively, it has many defects: 1) generally, it is less effective than in case of a simple bile leak; 2) the duration may be very long; 3) stent complications; and 4) long-term follow-up which may be not done. Thus on contrast of many reports[37-38] we can say that surgery is the preferable treatment for cases with bile leak associated with retained stone or stricture only in surgically suitable patients.

Many recent studies concluded that there was no role for endoscopic treatment in patients with transected CBD or anastomotic leak.[9,28] Similarly, our results showed that surgical treatment was the only definitive treatment of such problems; however endoscopy was a mandatory integral tool in the initial management either alone, or with percutaneous techniques. Without doubt, surgery has its associated morbidity and mortality, prerequisites, and necessary facilities.

The overall successful endoscopic treatment was 74.8% with variable rates for each problem and this was comparable with different reports detecting variable endoscopic success ranging from 78-94% of cases.[39-41]

Roux-en-Y hepaticojejunostomy is the best biliary reconstruction procedure, [42]however, choledochorrhaphy over T-tube and choledocho-duodenostomy were also indicated in some cases. [42,43] Unlikely these operations are so complex and advanced, particularly when the anastomosis is done on a normal duct that is technically very difficult especially with the associated fibrosis and infection.[44] Early surgical reconstruction can be done after proper assessment and before the spread of infection, however, most cases present late, where surgery is very difficult but still may be done.

Early referral to specialized centers with expert surgeons results in a better surgical outcomes.[45,46] Complications occurred in 72.3% of patients treated early versus 27.7% of patients treated electively. Also, 73.3% complication rate was encountered in patients initially treated before their referral in comparison to 38.8% in patients treated initially in our centers by experienced hepatobiliary surgeons. For these results, it is better to refer such patients early to a specialized center with expert surgeons.[44] The outcome of surgical treatment is affected by many factors,[47] but our series is too small to perform a multivariate analysis for their evaluation.

Conclusion

Endoscopic treatment replaced surgery in all simple postoperative bile leak cases as an identical definitive treatment. Surgical treatment was the definitive treatment of complex postoperative bile leakage; however endoscopy was a mandatory complementary tool in the initial management. Early referral to tertiary care centers with expertise in hepatobiliary surgery may limit further morbidity and mortality.

Conflict of interest statement

The authors declare that there is no conflict of interest.

Funding

This research received no specific grant from any funding agency in the public, commercial, or not for profit sectors.

Acknowledgment:

We express our appreciation to all staff members of general surgery department, and GIT endoscopy center, Sohag University hospitals, and South Valley University hospitals, Egypt; for their help during the conduct of this study.

Figure 1: Post cholecystectomy leakage and biloma collection as seen by CT (left) and MRI (right)

Figure2: Cystic duct leakage evident by ERCP, treated by sphincterotomy

Figure 3:Minor CBD laceration evident by ERCP, treated by sphincterotomy and stenting

Figure 4: Minor to major CBD laceration leakage, treated by ERCP sphincterotomy and stenting

Figure 5: Leakage around T-tube due to tube misplacement and papillitis; treated by tube extraction and sphincterotomy

Figure 6: Major CBD laceration leakage with ERCP success. The stent effluxing pus

Figure 7: Leakage due to distal CBD obstruction by stones; endoscopic treatment by sphincterotomy and stone retrieval by basket or balloon

Figure 8: major leakage associated with mid CBD stricture (left), stone hepatic duct (midle), and distal CBD obstruction by clotted blood due to hemobilia

Figure 9: Partial CBD transection injury; sometimes successfully treated by ERCP and straddling stent

Figure 10:delayed leakage with stricture/fistula formation (left), Rt. And Lt. peritoneal abscesses (middle); ERCP trial by dilation and stenting

Figure 11: Stents applied for CBD injury was upgraded in size and number as 2,3 or more CBD stents

Figure 13: Complex injury cannot be negotiated endoscopically as Rt. Anterior duct injury (left), Rt. sectorial duct injury, massive CBD laceration in the portahepatis (middle), CBD transection with loss segment (right)

Figure 14: Complex injury cannot be negotiated endoscopically as massive CBD transection injury with loss of CBD continuity (left, middle), and leakage with suspected duodenal injury

Table 1: Patients data

Table 2: Definitive management of bile duct injury

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