Research Article
Management of Postoperative Bile Leak: Tertiary Centers Experience
Mohammed A Omar1* and Alaa A Redwan2
1Department of Surgery, Qena Faculty of Medicine, South Valley University, Qena, Egypt
2Department of Surgery, Sohag Faculty of Medicine, Sohag University, Sohag, Egypt
*Corresponding author: Mohammed Ahmed Omar, Department of General Surgery, Qena Faculty of Medicine, South Valley University, 83511 Qena, Egypt
Published: 20 Nov, 2017
Cite this article as: Omar MA, Redwan AA. Management
of Postoperative Bile Leak: Tertiary
Centers Experience. Clin Surg. 2017;
2: 1743.
Abstract
Background: Bile duct leak is an infrequent but serious disorder. The great majority occurs
after hepatobiliary surgery. Early recognition and adequate multidisciplinary approach is the
cornerstone for the optimal final outcomes. Traditionally, surgery has been the gold standard for
the management of bile leak, but it is associated with significant morbidity and mortality. Biliary
endoscopic procedures have become the treatment of choice, as simple, noninvasive procedure,
with low morbidity and mortality, short hospital stay, and coast effective, with demonstrated
results comparable to those achieved with surgery. We aim to evaluate the optimal management of
postoperative bile leak.
Methods: In the period from January 2014 to October 2016, 155 patients with postoperative bile
leak referred to our tertiary specialized centers were managed and evaluated.
Results: The definitive management of bile leak was done within 0-143 days. Patients were managed
accordingly using, endoscopy in 116 patients (plus percutaneous techniques in 4 patients) and
surgery in 39 patients. The endoscopic treatment proved very effective in 94.7% of the patients with
simple bile leak and 44.2% of the patients with complex bile leak.
Conclusion: Endoscopic treatment substituted surgery in all simple bile leak cases as a competitive
treatment. Surgical treatment was the definitive treatment of complex bile leak; however endoscopy
was a mandatory complementary tool in initial management.
Keywords: Bile leak; Post operative; Percutaneous
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 two major tertiary referral centers in Egypt trying to answer
this question.
Figure 1
Figure 2
Figure 3
Figure 3
Leakage around misplaced T-tube with papillitis; treated by tube
extraction and sphincterotomy and stent.
Figure 4
Figure 5
Figure 6
Figure 6
Major CBD laceration leakage, treated by endoscopic
sphincterotomy and stent effluxing pus.
Figure 7
Figure 8
Figure 8
Complex injury cannot be negotiated endoscopically as Rt. Anterior
duct transection (left), Rt. sectorial duct transaction (middle), CBD transection
with loss segment (right).
Figure 9
Figure 9
Complex injury cannot be negotiated endoscopically as massive
CBD transection injury with loss of CBD continuity.
Methods
A 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 (Figure 1). 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. Patients
were classified simply according to cholangiographic and operative
findings into two groups; simple bile leak which include liver bed
leak, cystic duct leak (Figure 2), accessory duct leak, leakage around
T-tube (Figure 3), and leak with partial laceration of the ductal
system (Figures 4-7) and complex bile leak which include complete
duct transaction (Figure 8 and 9), retained stone (Figure 10 and 11)|,
stricture (Figures 12-14) or anastomotic leak (Figure 15). 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 cm - 12 cm), straddling the site of the
leak (Figures 2-7). For patients with bile leak and retained stones,
a sphincterotomy, stone removal, and stent insertion was done
(Figure 10 and 11). For patients with bile leak and duct stricture,
dilatation and a plastic stent(s) was done (Figure 13 and 14).
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 (Figure 16). 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 with large and diffuse collection not suitable
for percutaneous drainage or electively after failed (Figure 8 and 9)
or inappropriate nonsurgical tools treatment (Figure 17 and 18).
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 outpatient
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.
Figure 10
Figure 10
Leakage due to distal CBD obstruction by stones; treated by
endoscopic sphincterotomy, stone retrieval by basket and balloon and stent.
Figure 11
Figure 11
Leakage associated with distal CBD retained stones (left), and
retained hepatic duct stone (right).
Figure 12
Figure 13
Figure 13
Delayed leakage with stricture/fistula formation (left, middle),
treated by endoscopic sphincterotomy, dilatation and stent.
Figure 14
Figure 14
Major leakage due to distal CBD stricture; treated by endoscopic
sphincterotomy, dilatation and self expandable metal stent.
Figure 15
Figure 15
Operative picture for anastomotic leakage treated by redo
anastomosis, and post operative MRCP.
Figure 16
Figure 17
Figure 17
Operative photograph of biliary leakage with a common bile duct
stone, treated by drainage, choledocholithotomy and repair over T-tube.
Figure 18
Figure 18
A: Operative field showing ligated, excised common bile duct
with many stitches in the porta hepatis; B: Operative dissection of hepatic
ducts with Roux-en Y loop hepaticojejunostomy anastomosis; C: Roux-en-Y
hepaticojejunostomy completed with postoperative MRCP assurance.
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). Simple bile leak (94 patients): 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 transhepatic
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 (Table 3 and
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
2 patients in the surgical group (5.1%), (Table 5 and 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).
Table 1
Table 2
Table 3
Table 4
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 postcholecystectomy
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. 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%). Also percutaneous transhepatic 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. 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. 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% to 94% of
cases [39-41]. Roux-en-Y hepaticojejunostomy is the best biliary
reconstruction procedure [42], however, choledochorraphy over
T-tube and choledocho-duodenostomy were also indicated in some
cases [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. 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.
Table 5
Table 6
Table 7
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.
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