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- 1. FEATURE
Single Incision Laparoscopic Cholecystectomy Is Associated
With a Higher Bile Duct Injury Rate
A Review and a Word of Caution
Mark Joseph, MD, Michael R. Phillips, MD, Timothy M. Farrell, MD, and Christopher C. Rupp, MD
Objective: To compare the incidence of bile duct injuries during single incision laparoscopic cholecystectomy (SILC) in relation to the accepted historic
rate of 0.4% to 0.5% for standard laparoscopic cholecystectomy (SLC).
Background: Technically, SILC is more challenging than SLC. The role and
benefit of SILC in patient care has yet to be defined. Bile duct injuries have
been reported in several series of SILC.
Method: A comprehensive database search of MEDLINE, EMBASE,
CINAHL, and PubMed Central was performed to generate all reported cases
of SILC to present. The search was limited to reports of 20 or more patients based on current literature of existing SILC learning curves. Data were
analyzed using the Student t test and χ 2 analyses where appropriate.
Results: A total of 76 candidate studies were identified; 45 studies met inclusion criteria for an aggregate total of 2626 patients. Most SILCs were
performed in the absence of acute cholecystitis (90.6%). The aggregate complication rate was 4.2%, and complications were graded according to the
Dindo-Clavien Classification System. Nineteen bile duct injuries were identified for a SILC-associated bile duct injury rate of 0.72%.
Conclusions: There seems to be an increase in the rate of bile duct injuries
during SILC when compared with historic rates during SLC. Because most
SILCs are performed in optimal conditions, such as lack of acute inflammation,
we urge caution in applying this technique to inflamed gallbladder pathology.
Controlled trials are needed before conclusions are made regarding safety of
SILC.
(Ann Surg 2012;256:1–6)
T
he “laparoscopic revolution” in the 1990s resulted in a paradigm
shift such that many traditionally open procedures were supplanted by minimally invasive techniques. In the United States, where
approximately 750,000 cholecystectomies are performed annually, it
has become standard of care to approach many disease processes
of the gallbladder laparoscopically.1 Minimally invasive techniques
have resulted in dramatic improvement along many postoperative
metrics, including hospital stay, postoperative pain, blood loss, and
overall morbidity.2 In fact, most patients now expect a laparoscopic
approach when a cholecystectomy is considered.
During the transition from open to laparoscopic cholecystectomy, there was a dramatic increase in the incidence of bile duct
injuries. Traditionally, the bile duct injury rate for open cholecystectomy has been reported as approximately 0.2%.3 During the “learning
curve” while laparoscopic cholecystectomy was being introduced on
a global scale, early reports suggested increased bile duct injury
rates as high as 0.74% to 2.8%.4–6 Over time, the rate of bile duct
injuries settled to a new plateau, albeit at a higher level of approx-
imately 0.4% to 0.5%.7–9 Although there is still discussion whether
this incremental increase in bile duct injury is justified by the noted
benefits, laparoscopic cholecystectomy continues to remain the most
common surgical procedure performed by general surgeons in the
United States.1
Recently, technical improvements have allowed many
minimally-invasive procedures to be adapted to a reduced number
of incisions, and in many cases only 1 incision. Although various
monikers exist for this latest form of access, single site/single incision surgery is most common. In the literature, several groups have
described early experiences in single site surgery for several surgical
procedures, including single incision laparoscopic cholecystectomy
(SILC). Nearly all studies have shown operative metrics equivalent
to standard laparoscopic techniques, including length of surgery, operative blood loss, perioperative complications, and postoperative
recovery. In addition, most investigators have concluded that SILC is
safe and feasible.
However, several of the same studies also describe the occurrence of bile duct injuries. Because many of these series are of small
size, they are underpowered to determine if SILC bile duct injury
rate is equivalent to that of standard laparoscopic cholecystectomy
(SLC). Therefore, to develop a more valid estimate of the true rate of
SILC-associated bile duct injury, we aggregated available data using
a literature review to compare the rate of bile duct injury occurring
during this early “dissemination” phase of SILC to historic rates of
SLC-associated bile duct injury.
METHODS
Literature Search Strategy
Original published studies on SILC were identified by searching the MEDLINE, EMBASE, CINAHL, and PubMed Central
databases from January 1990 to February 2011. The following keywords and phrases were used: “single incision surgery,” “single site
surgery,” “single incision laparoscopic cholecystectomy,” “single site
laparoscopic cholecystectomy,” “single incision cholecystectomy,”
“minimally invasive cholecystectomy,” and “laparoendoscopic single site surgery.” Several combinations of the keywords and phrases
were utilized. The search was limited to articles published in English
with human patients. The reference lists of all retrieved articles were
manually reviewed to further identify potentially relevant studies. All
relevant articles identified were then assessed using predetermined
selection criteria.
Selection Criteria
From the Department of Surgery, University of North Carolina, Chapel Hill, NC.
Disclosure: The authors declare that they have nothing to disclose.
Reprints: Christopher C. Rupp, MD, University of North Carolina, 4035 Burnett
Womack Bldg, CB 7081, Chapel Hill, NC 27599. E-mail: crupp@med.unc.edu.
Copyright C 2012 by Lippincott Williams & Wilkins
ISSN: 0003-4932/12/25601-0001
DOI: 10.1097/SLA.0b013e3182583fde
Annals of Surgery r Volume 256, Number 1, July 2012
Studies that specifically addressed SILC were evaluated. For
institutions reporting updated experiences, only the most recent or
complete paper was selected for review. Studies were required to
have 20 or more patients to be considered for inclusion, as recent data
support this threshold for attaining similar operative proficiency in
SILC compared with SLC.10
www.annalsofsurgery.com | 1
Copyright © 2012 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
- 2. Annals of Surgery r Volume 256, Number 1, July 2012
Joseph et al
Data Extraction and Critical Appraisal
Each published article was critically reviewed using a standard protocol. Data extracted included patient demographics; inclusion/exclusion criteria; operative metrics including length of surgery,
blood loss, complications, and technique used for SILC; perioperative variables including morbidity, mortality, and bile duct injuries.
All data were extracted and tabulated from the relevant text, tables,
and figures. The method of gallbladder retraction or exposure was categorized as either by internal grasper retraction, percutaneous suture
retraction, or a combined technique, along with the technical details
of each study. Although some investigators used commercially available devices for assistance, others did not. The number of trocars or
access ports used was also recorded.
After tabulation of the results, the rate and type of complication
along with morbidity, mortality, and bile duct injury occurrences were
synthesized. Reported surgical complications were graded according
to the Clavien-Dindo Classification of Surgical Complications System (Table 1).11 Bile duct injuries reported in each study were categorized according to the Strasberg Bile Duct Injury Classification
System (Table 2).12 Meta-analysis was not appropriate because of
the heterogeneous nature of the included studies and the lack of a
controlled comparative arm.
Data were analyzed with the Microsoft Excel software package
(Microsoft Corporation, Redmond, WA) in combination with GraphPad Software (GraphPad Software, La Jolla, CA) with the assistance
of a biostatistician. Statistical analysis of continuous operative metrics was performed using a Student t test. Categorical variables were
TABLE 1. Clavien-Dindo Classification of Surgical
Complications11
Grade
I
II
III
III-a
III-b
IV
IV-a
IV-b
V
Definition
Any deviation from the normal postoperative course
without the need for pharmacological treatment or
surgical, endoscopic, and radiologic interventions∗
Requiring pharmacological treatment with drugs other than
such allowed for grade I complications; this includes
blood transfusions
Requiring surgical, endoscopic, or radiological intervention
Intervention not under general anesthesia
Intervention under general anesthesia
Life-threatening complication requiring intensive care unit
management
Single organ dysfunction (including dialysis)
Multi-organ dysfunction
Death of patient
∗
Acceptable therapeutic regimens are drugs such as antiemetics, antipyretics,
analgesics, and diuretics, and electrolyte physiotherapy. This grade also includes
wound infections opened at the bedside.
TABLE 2. Strasberg Bile Duct Injury Classification12
Bile Duct
Injury Type
A
B
C
D
E
Definition
Bile leak from a minor duct still in continuity with
the common bile duct
Occlusion of part of biliary tree
Bile leak from duct not in communication with
common bile duct
Lateral injury to extrahepatic bile ducts
Circumferential injury of major bile ducts (Bismuth
class 1 to 5)
2 | www.annalsofsurgery.com
analyzed with the χ 2 test. Overall statistical significance was set at
P < 0.05.
RESULTS
A total of 76 published reports were identified that were
relevant to SILC. Thirty-one studies contained fewer than 20 patients,
and were thus excluded according to our selection criteria. The
remaining 45 studies were analyzed for patient- and disease-specific
data (age, body mass index [BMI], percent of patients with acute
cholecystitis), and technique-specific details (gallbladder retraction
method, devices used, number of access ports needed) (Table 3).
In aggregate, 2626 patients underwent SILC; 72% of patients were
female. Median age was 45 years with a median BMI of 27 kg/m2
(Table 4). Of note, patients with acute cholecystitis accounted for
only 9.4% of patients. Median length of operation was 71 minutes.
Patients (2.5%) required conversion to SLC, and 0.3% patients
required conversion to an open cholecystectomy. Intraoperative
cholangiography was utilized in 13.4% of patients.
A total of 19 bile duct injuries were identified for a bile duct
injury rate of 0.72%. Table 5 lists the studies and types of bile duct
injuries according to the Strasberg Bile Duct Injury Classification
System.12 Of note, 11 of the 19 bile duct injuries (58%) were categorized as type A.
Technical details, as recorded in Table 3, were analyzed for
bile duct injuries. Despite several variations in technique, the gallbladder retraction method, commercial device utilization, or number
of ports/trocars used was not associated with an increase in the bile
duct injury rate (P = NS). In addition, the occurrence of bile duct
injuries did not correlate with shorter or longer lengths of surgery
(P = NS).
Overall, the complication rate was 4.2%. Complications
were graded according to the Dindo-Clavien Classification System
(Table 5).11 The number of complications was not associated with
the occurrence of bile duct injuries (P = NS). The presence of acute
cholecystitis was not associated with a statistically different rate of
bile duct injuries (P = NS).
DISCUSSION
Several investigators have reported on their initial experience
with SILC, including our own group.13 Although the technique is feasible, there are inherent difficulties that require increased laparoscopic
competency, namely, restricted instrument mobility and arguably reduced visualization of key components of a cholecystectomy. We
have previously reported our experience with 101 SILCs, in which
we maintained rigorous adherence to the Critical View of Safety technique described by Strasberg et al12 Inherent in this technique are 3
tenets: (1) the Triangle of Calot must be cleared of all fat and fibrous tissue, (2) the lowest part of the gallbladder must be separated
from the cystic plate, and (3) 2 structures, and only 2, should be seen
entering the gallbladder. When these criteria could not be fulfilled,
conversion to SLC ensued, which accounted for a higher rate of conversion to SLC in our series (12%) as compared with others.13 We
did not experience a bile duct injury at the time of publication and
have not had any biliary strictures or injuries identified at an average
of 1-year follow-up.
Historically, the rate of bile duct injury in the era of open
cholecystectomy was approximately 0.2%. During the 1990s, which
correlates with the implementation of laparoscopic techniques for
cholecystectomy, there was a sharp rise in the bile duct injury rate.
Over time, the bile duct injury rate decreased, presumably as more experience with laparoscopic techniques occurred, but not to rates seen
in the “prelaparoscopic” era. Latest estimates put the new plateau at
0.4% to 0.5%.1 Although there is still much discussion about what defines an “acceptable” rate of bile duct injury during cholecystectomy,
C
2012 Lippincott Williams & Wilkins
Copyright © 2012 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
- 3. Annals of Surgery r Volume 256, Number 1, July 2012
SILC and Bile Duct Injuries
TABLE 3. Selected Study Metrics and SILC Approach Variables
Author
Year
No.
Patients
Alvarez16
Aprea17
Bagloo18
Bokobza40
Bresadola19
Brody41
Chang20
Ching Li21
Chow42
Curcillo43
De Campos44
Dominguez22
Duron45
Edwards46
Elsey23
Erbella24
Ersin25
Ertem47
Fronza26
Han27
Hawasli48
Hernandez10
Kirshniak28
Kravetz49
Kuon Lee29
Lee30
Mutter31
Navarra 50
Navarra 51
Nougues52
Patel53
Philipp54
Rao32
Rawlings33
Rivas55
Roberts56
Romanelli57
Roy58
Rupp13
Schlager34
Shussman59
Tsimoyiannis60
Wen61
Wu35
You62
2010
2011
2010
2010
1999
2009
2011
2010
2010
2010
2009
2009
2010
2010
2010
2010
2010
2010
2010
2011
2010
2009
2009
2009
2009
2010
2010
2010
1997
2010
2010
2009
2008
2010
2010
2010
2010
2010
2011
2010
2011
2009
2010
2010
2010
30
25
40
65
28
59
30
40
23
297
81
40
55
80
238
100
20
23
25
64
71
150
38
20
37
35
61
20
30
25
20
29
20
54
100
53
22
50
101
20
31
20
50
100
106
BMI
Gallbladder
Retraction
Method
Commercial
Access Device
Used?
Ports Used
Mean
Duration of
Surgery, min
25.8
25.9
27.81
25
NR
29.2
NR
24.57
26.5
NR
NR
28
29.1
26.5
NR
26.5
26.5
<30
25.4
23.9
<40
29
27.8
30.2
22.3
24.2
25.7
27
NR
NR
NR
30
NR
27.7
29.8
30.2
32.7
NR
29.9
27
26
NR
NR
NR
23
0
0
7.5
15.4
NR
23.7
13.3
0
NR
NR
3.7
0
10.9
25
25.2
0
0
0
0
4.7
NR
0
0
20
0
0
4.9
25
NR
8
0
6.9
0
0
5
9.4
0
0
15
20
16.1
0
20
NR
NR
IGR
PSR
IGR
Combined
PSR
PSR
PSR
IGR
PSR
Combined
IGR
IGR
Combined
PSR
PSR
PSR
PSR
PSR
PSR
IGR
PSR
PSR
IGR
Combined
IGR
Combined
Combined
PSR
PSR
IGR
PSR
PSR
Combined
PSR
PSR
Combined
PSR
IGR
PSR
Combined
Combined
Combined
Combined
IGR
IGR
Yes
No
No
Yes
No
No
Yes
No
No
No
Yes
No
Yes
No
No
No
No
No
Yes
No
No
No
No
Yes
No
Yes
Yes
No
No
No
Yes
Yes
No
No
Yes
Yes
Yes
No
No
No
No
No
No
No
Yes
3
3
4
3
2
2
3
3
3
3
4
1
3
3
3
2
3
3
3
3
3
3
3
3
3
4
3
3
2
3
3
3
3
3
2
3
2–3
4
2
2–3
2–3
3
3
3
3
65
41
102
68
94
93
86
54
127
71
68
93
67
70
40
30
94
46
100
92
49
75
67
68
84
72
68
53
123
73
103
85
40
113
51
80
81
55
76
136
115
50
77
54
58
Age, y
34.8
45.5
45
49
42
45
48
46.9
40
46
48
48
44.2
42.3
39
44.9
44.9
34
44.2
47
45
46.1
53.8
43.9
47.5
51
47.5
45
NR
12
42
38
NR
47
33.8
41
40
44.9
43.8
40.7
39.2
49.2
NR
46.2
45
Acute
Cholecystitis,
%
IGR indicates internal grasper retraction; NR, not recorded; PSR, percutaneous suture retraction.
TABLE 4. Combined Patient Demographics∗
No. patients
Men
Women
Age, mean (median), y
BMI, mean (median), kg/m2
Median duration of surgery, min
∗
2626
733 (27.9%)
1893 (72.1%)
43.3 (45)
23.8 (27)
71.1
Values calculated from studies reporting data for analysis.
common practice favors laparoscopic approach to shorten hospital
stay and postoperative recovery.2
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2012 Lippincott Williams & Wilkins
We have shown in this study what seems to be an increase in
the rate of bile duct injuries occurring with the introduction of another new method for cholecystectomy. As stated previously, nearly
all studies included in our analysis reported that SILC was feasible
and safe, even those that recorded bile duct injuries in a small number
of patients. However, when the results are assessed in aggregate, our
current estimates put the incidence of SILC bile duct injuries slightly
more than 0.7%. With an estimated 750,000 cholecystectomies performed in the United States per year and a baseline SLC bile duct
injury rate of 0.4% to 0.5%,1 widespread application of SILC methods would result in 3000 to 5100 additional bile duct injuries per
year, or an 85% increase. Although this calculation is hypothetical,
it does highlight the need for further discussion, as the general trend
in surgery is toward increasingly less invasive approaches for many
operations.
www.annalsofsurgery.com | 3
Copyright © 2012 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
- 4. Annals of Surgery r Volume 256, Number 1, July 2012
Joseph et al
TABLE 5. Complication Grade and Bile Duct Injuries
Authors
Alvarez16 ‡
Aprea17
Bagloo18
Bokobza40
Bresadola19
Brody41
Chang20
Ching Li21
Chow42 ‡
Curcillo43 ‡
De Campos44
Dominguez22
Duron45
Edwards46 ‡
Elsey23
Erbella24
Ersin25
Ertem47
Fronza26
Han27 ‡
Hawasli48
Hernandez10 ‡
Kirshniak28
Kravetz49
Kuon Lee29 ‡
Lee30
Mutter31
Navarra50
Navarra51
Nougues52
Patel53
Philipp54
Rao32
Rawlings33
Rivas55
Roberts56 ‡
Romanelli57
Roy58 ‡
Rupp13
Schlager34 ‡
Shussman59
Tsimoyiannis60 ‡
Wen61
Wu35 ‡
You62 ‡
Total
No. Total
Complications
Dindo-Clavien
Complication Grade∗
No. Bile Duct
Injuries
Types of Bile
Duct Injury†
3
0
1
3
0
2
NR
0
1
19
11
3
0
7
5
0
0
0
3
6
3
7
0
0
2
1
0
0
1
0
0
7
0
2
2
3
1
4
5
1
0
2
2
2
2
111
1 (2), 3a (1)
—
3b (1)
1 (2), 3b (1)
1
A
1
2
A
N/A
3
A, A, A
2
C, E2
2
A, N/A
1
D
1
A
1
C
1
A
2
A, A
1
1
19
A
B
3a (1), 2 (1)
—
—
3a (1)
1 (16), 3a (2), 4a (1)
1 (11)
1 (3)
3a (3), 1 (4)
1 (5)
—
1 (3)
4a (1), 1 (5)
1 (3)
3a (2), 1 (5)
—
—
1 (1), 3a (1)
1
—
—
1
—
—
1 (7)
—
1 (2)
1 (1), 3a (1)
1 (1), 3a (2)
3b (1)
3a (1), 1 (3)
2 (1), 1 (3), 3b (1)
3a (1)
—
3a (2)
1 (2)
1 (1), 3a (1)
3b (2)
∗
Number of each complication shown in parentheses.
†Classified according to Strasberg et al.12
‡Studies reporting bile duct injuries
N/A indicates unable to determine bile duct injury class in 2 injuries on the basis of data provided in respective study.
Our aggregate data set shows an overall complication rate of
4% associated with SILC, and these complications have been further graded according to the Dindo-Clavien Complication Grading
System (Table 5). Although complication rates for SLC vary greatly
between studies, a meta-analysis published in 2009 found an aggregate postoperative complication rate of 8.6%, although a definable
complication classification system was not employed.14 We did not
draw conclusions regarding total complications identified in our review because of the difficulty in accurately interpreting the reported
complications within the included series. Very few published studies
use a grading scale similar to the Dindo-Clavien Complication Grad4 | www.annalsofsurgery.com
ing System, which confounds the already difficult task of interpreting
data across studies. In addition, no particular variation in operative
technique (Table 3) was associated with an increased bile duct injury
rate. However, in a study of this type there is a high possibility of type
II error. This point, in addition to the heterogeneity of the studies, may
very well have precluded the possibility of finding any differences.
It should also be noted that SILCs within the included studies
in this analysis were performed under nearly ideal operative circumstances. The incidence of acute cholecystitis was only 9.4% across the
series, suggesting that most SILCs were performed in the absence of
acute inflammation, a condition that is a known risk factor for several
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2012 Lippincott Williams & Wilkins
Copyright © 2012 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
- 5. Annals of Surgery r Volume 256, Number 1, July 2012
complications including bile duct injuries.15 Several of the studies
included in our analysis note that the presence of acute cholecystitis
was used as an exclusion factor in the determining whether to proceed
with SILC versus SLC.16–35 Although the study investigators should
be commended for limiting their application of SILC methods to disease processes without an acute inflammatory component, the result
is that our aggregate database contains mostly cases at low risk for
biliary injury, namely those performed in the best of circumstances
(ie, minimal inflammation). Although no investigator has published
results of SILC specifically performed for acute cholecystitis, the
natural progression of a new surgical technique to broader indications as surgeons become facile with SILC would suggest that this
will soon be evaluated. We speculate that there may be even greater
risk for bile duct injuries if the absence of regulation allows dissemination of this technique to include the full spectrum of gallbladder
disease.
Also of note, intraoperative cholangiography was utilized in
only 13.4% of cholecystectomies. The debate whether to perform routine or selective cholangiography has by no means been concluded. Be
that as it may, the most recent data available in the United States and
the United Kingdom reported a rate of routine cholangiography use of
27% and 24%, respectively.36,37 In Australia, cholangiography is performed in more than 60% of cholecystectomies.38 It is unclear from
our data why the aggregate intraoperative cholangiography use seems
to be less than that reported for SLC. This could reflect the selected
investigator’s surgical preference for not using routine cholangiography or lack of acute pathology necessitating cholangiography, or it
could reflect a higher level of difficulty in performing this through a
single incision technique. Although it is speculative whether the use
of cholangiography could be inversely related to the bile duct injury
rate, we believe it warrants further investigation.
Finally, the issue of regulation and monitoring has been raised
at the 2010 meeting of the American Hepato-Pancreato-Biliary
Association.39 It was noted that the introduction of SILC has similarities to the ad hoc introduction of laparoscopic cholecystectomy,
which was associated with an increase in the rate of bile duct injuries.
No regulatory agency or society at that time was able to monitor injury
rates or perform quality control. Similarities exist now with the introduction and dissemination of SILC, and there is still no regulatory
control or quality assurance being performed outside of a handful of
medical centers. In fact, as with many new surgical techniques, it is not
always mandatory to obtain Institutional Review Board authorization
before performing a new procedure on an actual human patient.
Our study is limited by the fact that it is retrospective in nature and dependent on accurate reporting of bile duct injuries. The
importance of this cannot be stressed enough, as we speculate that
there is likely tremendous publication bias present against publishing poor results, especially because this technique is still in its early
development phase. As with many new surgical techniques, complications are monitored and scrutinized even more than usual, for good
reason. We speculate that those investigators publishing their results
represent the “cream of the crop,” and that the actual bile duct injury
rate could be higher if there is truly underreporting of the bile duct
injury rate out of fear of criticism.
Although bile duct injuries are reported in the respective studies, there is limited detail regarding the interventions required for
resolution. In addition, although the aggregate number of patients in
the 45 studies included in this study is 2626, this is still a relatively
small number of patients. Our findings may not be confirmed once
large-scale studies are performed in the future. However, we believe
these data suggest an increase is occurring once again in the rate of
bile duct injuries. The surgical community should be cautious not to
repeat the mistakes that occurred during the dissemination phase of
laparoscopic surgery. This is especially pertinent given the fact that
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SILC and Bile Duct Injuries
no distinct benefit of SILC over SLC has been identified to date, with
the arguable exception of cosmesis.
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