ABSTRACT
ObjectivesComparison between early and delayed surgical repair of an iatrogenic
biliary duct injury during cholecystectomy referred to a hepatobiliary surgeon
in terms of mortality and early and long-term morbidity.
Methods and MaterialsBetween January 2004 and June 2018, a retrospective analysis was done on
63 patients with bile duct injuries who were referred to KHMC (King Hussein
medical centre/ Hepatobiliary Unit). All patients with an attempt at repair by
the primary surgeon (11 cases) managed non-surgically were also excluded (13
cases) from the study. The remaining 39 patients were analysed in this study,
13 males and 26 females with biliary injury. Of these, 11 patients were
diagnosed intraoperatively, and 28 patients were diagnosed postoperatively. In
all, 8 patients developed biliary injury during open cholecystectomy and 31
patients during laparoscopic cholecystectomy.
ResultsThe bile
duct injuries were classified using the Bismuth-Strasberg classification of
bile duct injury, ranging from type A to type E. Complete preoperative
cholangiography was achieved in almost all cases. Preoperative percutaneous
drainage required in ten patients for bile collections, and one for a
subhepatic abscess. Twenty patients underwent biliary reconstruction within 6
weeks of the injury (median time = 2 weeks) and 19 patients after 6 weeks
(median time= 13 weeks). All patients were managed by Roux-en-Y
hepaticojejunostomy, except one patient who was managed by laparoscopic suture
closure of the cystic duct. Three patients required surgical revision of the
hepaticojejunostomy, one in the late and two in the early group. Successful
surgical reconstruction was possible in early surgical repairs. There was no
mortality among both groups in the early perioperative period.
ConclusionEarly surgical repair of biliary injury is successful in most of the
cases when undertaken by a hepatobiliary surgeon, with early referral to a
tertiary care centre, and the outcome is similar to that of delayed repair.
Keywords: bile duct injury, early bile duct injury repair, Delayed bile duct
injury repair, Bismuth-Strasberg classification, laparoscopic cholecystectomy.
RMS August 2022; 29 (2): 10.12816/0061167
INTRODUCTION
With the introduction of laparoscopic cholecystectomy, the number of
bile duct injuries has increased markedly [1].
Initially the incidence of iatrogenic laparoscopic bile duct injury was
around 10-fold that of open cholecystectomy, but with the increased experience
in this technique, the incidence has decreased drastically but remains higher
than that of open cholecystectomy (0.3–0.7% vs. 0.1–0.3%) [2]. However, the number of cholecystectomies
has increased worldwide with the introduction of the laparoscopic approach, and
even with improved surgeon experience with this approach, the rate of biliary
injury remains constant. Hence, bile duct injury following cholecystectomy
(both open and laparoscopic) continues to be a problem [3].
The presentation, diagnosis and management of these injuries may be
challenging in most of these cases. A multidisciplinary approach, including a
gastroenterologist, hepatobiliary surgeon, interventional radiologist and
psychiatrist, is required during the management of such a complex disease [4].
Many factors influence the outcome of bile duct injury repair, including
general health status of the patient, duration of illness, level of injury,
eradication of any associated intra-abdominal infection, achievement of
complete preoperative cholangiography, surgeon experience performing the repair
and correct surgical repair. In fact, bile duct injury results in a serious
complication and long-term morbidity and impaired quality of life [4–7]. The optimal
timing of surgical repair of bile duct injury still matter of debate and
controversies. The current study examines the early and delayed surgical repair
of an iatrogenic biliary duct injury during cholecystectomy referred to a
hepatobiliary surgeon in terms of mortality and early and long-term morbidity.
PATIENTS AND METHODS
Between January 2004 and June 2018, a retrospective
study that included 63 patients with bile duct injuries who were
referred to KHMC (Hepatobiliary Unit). All patients with an attempt at repair
by the primary surgeon were excluded 17.5% (11 cases), and all patients managed
non-surgically were also excluded 20.6% (13 cases) from the study. The
remaining 39 (62%) patients were analysed in this study, 13 (33.3%) males and
26 (66.6%) females with biliary injury. In all, 11 (28.2%) patients were
diagnosed with biliary injury intraoperatively and 28 (71.8%) patients were
diagnosed postoperatively. In all, 8 (20.5%) patients developed biliary injury
during open cholecystectomy and 31(79.5%) patients during laparoscopic
cholecystectomy (Table I). The bile duct injuries were classified using the
Bismuth-Strasberg classification of bile duct injury (Type A: injury with a
leak in the duct of Luschka or the cystic duct. Type B: injury to a sectoral
duct resulting in obstruction of the sectorial duct. Type C: injury to a
sectoral duct with bile leak. Type D: lateral injury to the extrahepatic
biliary ducts. Type E1: stricture more than 2 cm from the bile duct confluence. Type E2: stricture within 2 cm of
the bile duct confluence. Type E3:
stricture at the confluence with continuity.
Type E4: stricture involving the right and left bile ducts, without continuity.
Type E5: complete occlusion of all bile ducts, including sectoral ducts).
Table I. Demographics and initial operation.
%
|
Number
|
Demographics
|
Age (years)
|
|
42
|
Mean
|
|
43 (18–67)
|
Median
|
Gender
|
|
33.3%
|
13
|
Male
|
66.7%
|
26
|
Female
|
Type of operation
|
20.5%
|
8
|
Open cholecystectomy
|
79.5%
|
31
|
Laparoscopic cholecystectomy
|
Onset of recognition of the
injury
|
28.2%
|
11
|
Intraoperatively
|
71.8%
|
28
|
Postoperatively
|
Most of the patients were referred from a community hospital, except for
seven (17.5%) cases from an academic hospital. The time from injury to referral
varied according to the time of diagnosis and range from immediate transfer
after intraoperative diagnosis of bile duct injury to 19 weeks postinjury, with
mean time of referral of 11 ± 5 weeks (Table II).
Table II Time from injury to referral (in weeks) and presentation.
|
n = 39
|
Time from
injury to referral
|
|
0–19 weeks
|
Range
|
|
11 ± 5 weeks
|
Mean
|
|
3 weeks
|
Median
|
%
|
n = 39
|
Referral hospital
|
82.0
|
32
|
Community hospital
|
18.0
|
7
|
Academic hospital
|
The most common presenting signs and symptoms
were biloma (25.6%), cholangitis (20.5%), jaundice (7.7 %) and no acute
complications (28.2%), which was the case in patients diagnosed with bile duct
injury intraoperatively (Table-III and graph-1).
TableIII. Presentation.
Presentation
|
Frequency
|
Percent
|
Valid Percent
|
Cumulative Percent
|
NO ACUTE COMPLICATIONS
|
11
|
28.2
|
28.2
|
28.2
|
CHOLANGITIS
|
8
|
20.5
|
20.5
|
48.7
|
JAUNDICE
|
3
|
7.7
|
7.7
|
56.4
|
BILOMA
|
10
|
25.6
|
25.6
|
82.1
|
ABDOMINAL PAIN
|
3
|
7.7
|
7.7
|
89.7
|
BILE LEAK FROM THE WOUND
|
1
|
2.6
|
2.6
|
92.3
|
ABNORMAL LFTs
|
2
|
5.1
|
5.1
|
97.4
|
SUBHEPATIC ABSCESS
|
1
|
2.6
|
2.6
|
100.0
|
Total
|
39
|
100.0
|
100.0
|
100.0
|
All patients with a bile duct injury underwent abdominal
ultrasonography, abdominal CT scan and MRCP. Nine patients underwent ERCP, and
seven patients required PTC to achieve complete preoperative cholangiography or
preoperative biliary drainage. Ten patients required preoperative percutaneous
drainage of a biloma, and one patient required preoperative percutaneous
drainage of a subhepatic abscess (Table IV).
The bile duct injuries were classified using the Bismuth-Strasberg
classification of bile duct injury, ranging from type A to type E. Most of the
injuries were type E (64.1%), and the most common type of injury was type E1
(25.6%) (Table-V and graph-2).
Table
IV Preoperative imaging and percutaneous drainage
%
|
Frequency
|
|
100
|
All
|
Abdominal US
|
100
|
All
|
Abdominal CT scan
|
100
|
All
|
MRCP
|
23.1
|
9
|
ERCP
|
18.0
|
7
|
PTC
|
25.6
|
10
|
Percutaneous drainage of
biloma
|
2.6
|
1
|
Percutaneous drainage of
abscess
|
Table V. Type of bile duct injury according to
Bismuth-Strasberg classification.
Bismuth-Strasberg type
|
Frequency
|
Percent
|
Valid Percent
|
Cumulative Percent
|
Type A
|
1
|
2.6
|
2.6
|
2.6
|
Type B
|
2
|
5.1
|
5.1
|
7.7
|
Type C
|
4
|
10.3
|
10.3
|
17.9
|
Type D
|
7
|
17.9
|
17.9
|
35.9
|
Type E1
|
10
|
25.6
|
25.6
|
61.5
|
Type E2
|
7
|
17.9
|
17.9
|
79.5
|
Type E3
|
4
|
10.3
|
10.3
|
89.7
|
Type E4
|
3
|
7.7
|
7.7
|
97.4
|
Type E5
|
1
|
2.6
|
2.6
|
100.0
|
Total
|
39
|
100.0
|
100.0
|
|
Study variables and statistical analysis
Study variables included patient's demographic characteristics,
type of primary operation, onset of recognition of the injury, time from injury
to referral, referral hospital, presentation, diagnostic procedures, type of
bile duct injury according to Bismuth-Strasberg classification and postoperative
complications defined by Clavien-Dindo classification. The primary endpoint
of the study was the comparison of mortality as well as the early and long-term
outcomes between patients who underwent early or delayed reconstruction of the
bile duct injury.
Patients were divided into two groups based on the timing of
definitive biliary repair or reconstruction: early (≤ 6 weeks after index
procedure) and delayed (> 6 weeks after index procedure). Data analyses were
performed with IBM SPSS Statistics version 25. Continuous and categorical
variables were presented as means, medians,ranges,counts, and percentages,
respectively. Categorical variables were analyzed using Fisher's exact test. A
P < 0.05 was considered statistically significant.
RESULTS
The study cases included 39 patients with major bile duct injuries, and
complete preoperative cholangiography was achieved in almost all cases by MRCP,
PTC or ERCP. All patients (10 cases) with intra-abdominal collections underwent
preoperative percutaneous drainage of bile collections, and one patient
required preoperative percutaneous drainage of a subhepatic abscess. Twenty
patients underwent early biliary reconstruction within 6 weeks of the injury
(median time from injury to repair 2 weeks), and 19 patients underwent late
biliary reconstruction after 6 weeks, ranging from 6 to 27 weeks (median time
from injury to repair 13 weeks). A total of 38 patients were managed by
end-to-side Roux-en-Y hepaticojejunostomy using interrupted single layer
absorbable 4-0 to 6-0 sutures, and one patient with a type A injury was managed
by laparoscopic suture closure of the cystic duct after failure of endoscopic
management of the bile leak using endobiliary stent and percutaneous drainage
of a biloma for 9 weeks. The mean follow-up period of patients was 32 months (18– 67
months).
Wound infection occurred in two cases and was managed by wound drainage
and intravenous antibiotics (one in the early repair group and one in the late
repair group), and the difference was statically insignificant (95% CI, P = 1.0000). Five patients developed cholangitis postoperatively
(three in the early repair group and two in the late repair group), and the
difference was also statically insignificant (95%
CI, P = 1.0000). Seven
patients developed anastomotic strictures. Five of these patients were managed
successfully by percutaneous dilatation and endobiliary stenting, while two
patients required revision of the anastomosis due to failure of stricture
dilatation by PTC (one in the early repair group and one in the late repair
group), which was statically insignificant (95%
CI, P = 0.6948). One
patient in the early repair group required surgical revision of the
hepaticojejunostomy due to a bile leak from a disrupted repair, which was
statically insignificant (95% CI, P = 1.0000). The overall postoperative
complication rate was 42.6% (18/39 patients), with 10 patients in the early
repair group and eight patients in the late repair group (95% CI, P
= 0.7512). Successful surgical reconstruction was possible in 18 of 20 early
surgical repairs compared with 18 of 19 delayed surgical repairs (95% CI, P
= 1.0000). There was no mortality among both groups in the early perioperative
period (Table VI ).
The mean follow-up of patients was 32 months (18– 67 months).
Table VI Postoperative
complications and surgical outcomes
|
n = 39
|
Early repair group (n
= 20)
|
Late repair group (n
= 19)
|
P
|
Wound infection
|
2 (5.1%)
|
1
|
1
|
1.0000
|
Cholangitis
|
5 (12.8%)
|
3
|
2
|
1.0000
|
Stricture
|
7 (17.9%)
|
3
|
4
|
0.6948
|
Major bile leak
|
1 (2.6%)
|
1
|
0
|
1.0000
|
Revision of the hepaticojejunostomy
|
3 (7.7%)
|
2 (1 stricture and 1
bile leak)
|
1 (stricture)
|
1.0000
|
Overall postoperative complication rate
|
18/39 (46.2%)
|
10/10 (50%)
|
8/19(42.1%)
|
0.7512
|
Successful surgical repair
|
36 (92.3%)
|
18/20 (90)
|
18/19 (94.7%)
|
1.0000
|
DISCUSSION
There is a great frequency of cholecystectomy worldwide. Gallstones are
extremely common in Western society, approximately 15% of the American
population is found to have gallstones, and over 700,000
cholecystectomies are performed every year in the United States [8]. This operation remains the most common
cause of bile duct injury [9], and with
the introduction of the laparoscopic approach, the incidence of bile duct
injury has increased substantially [9].
The incidence of bile duct injury following open
cholecystectomy is between 0.1% and 0.2%. In comparison, laparoscopic
cholecystectomy has a reported incidence of bile duct injury between 0.3% and
0.7%. Suspicion bile duct injuries and appropriate early referral can reduce
the chances of litigation [10,11]. It has been suggested that
at least half of all general surgeons may encounter bile duct injuries during their
surgical career [12]. Other causes of biliary injury include
biliary surgery (such as choledochotomy)
or surgeries involving organs in the upper
abdomen (such as gastric, pancreatic, hepatic surgeries), liver transplantation
and hepatoduodenal ligament lymphadenectomy [13,14].
Bile duct injury is associated with several factors,
and the most frequent cause is the classical Davidoff
injury, which is the misidentification of the bile duct as the cystic duct at its insertion
into the common hepatic duct (visual perception illusion) resulting in
clipping, ligating and dividing of these structures [15]. Damage to the
pericholedochal arterial plexus from excessive dissection along the common bile
duct is another potential cause of bile duct injury [16], and obliteration of
Calot’s triangle by dense fibrosis and inflammation secondary to acute and
chronic inflammatory processes increases the risk of bile duct injury [17]. Based on
the location of bile duct injury , width of bile duct injury, mechanism of
injury and associated vascular injury, as well as the complexity of bile duct
injury, several classification systems have been devised, such as the
Corlette-Bismuth classification, Strasberg classification, McMahon
classification, Stewart-Way classification and Hannover classification [18–21].
However, none of these proposed classifications are ideal or address all of the
issues previously mentioned (figures 1-4).
Figure 1: Intraoperative image of bile duct injury (Strasberg type E4) in a patient presented with obstructive jaundice.
Figure 2: Intraoperative image of bile duct injury with a
clip at the right hepatic artery (Hannover type C4dbileduct injury) in a
patient presented with obstructive jaundice and mildly elevated liver
transaminases.
Figure 3: Intraoperative image of bile duct injury (Strasberg
type E4)
in a patient presented with obstructive jaundice.
Figure 4: Intraoperative
image of bile duct injury (Strasberg type E4)managed by hepaticojejunostomy.
The timing of bile duct repair after a bile duct
injury sustained during a cholecystectomy is still a matter of debate, and
several studies have investigated the timing of biliary reconstruction in terms
of outcomes. Several series have reported negative outcomes for early biliary
reconstruction performed within 6 weeks of the injury [22–25]. Others have
reported the best outcomes for repair in the immediate period (< 72 hours
after the injury) or after 6 weeks due to significant associations with biliary
stricture during early repair (< 72 hours and>6 weeks after the injury) [26]. Some series
have also reported worse outcomes during early repair [27], whereas others have
shown no differences in outcomes related to the timing of the repair [28–30]. A
recent systemic review and meta-analysis by Wang et al. found early
referral and delayed repair were associated with the most favourable outcomes [31].
Biliary reconstruction in most of the cases was challenging because of
the high level of injury and presence of concomitant inflammation and
intra-abdominal infections. We think that successful repair in these cases
requires a multidisciplinary team [32,33],
experienced biliary surgeon and complete preoperative management, including
control of intra-abdominal collections and complete preoperative images.
In our study, successful biliodigestive
flow was established in 36/39 patients (91%) with no statistical
differences in the early or late repair groups. We did not find any correlation
between the timing of biliary repair, postoperative complications and
successful surgical repair. If the patient’s condition is optimized prior to
the operation and complete preoperative cholangiography is achieved to guide
the plane of surgery, the success of surgical biliary repair has no significant
differences regarding early vs. late
repair.
CONCLUSSION
Early surgical repair of biliary injury is successful in most of the
cases when undertaken by a hepatobiliary surgeon, with early referral to a
tertiary care centre, and the outcome is similar to that of delayed repair when
the patient’s condition is optimized and complete preoperative cholangiography
is achieved.
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