Journal of Visceral Surgery (2014) 151, 241244

Available online at

ScienceDirect
www.sciencedirect.com

FCVD GUIDELINES

Risk management to decrease bile duct

injury associated with cholecystectomy:
Measures to improve patient safety
Fdration de chirurgie viscrale et digestive
6, rue Ptrarque, 31000 Toulouse, France
Available online 6 May 2014

Composition of the organizational and work groups and of the Jury

Organizational committee
President: B. Millat
FCVD Ofce (in alphabetical order): D. Collet, A. Deleuze, O. Farges, J.F. Gravi,
H. Johanet, M. Mathonnet, K. Slim
Work group (in alphabetical order)
P. Ah-Soune, B. Aublet-Cuvelier, L. Barbier, M. Barthet, J.E. Bazin, E. Bloom, I. Dagher,
A. Deleuze, O. Farges, D. Fucks, F. Fuz, J.F. Gravi, D. Lechaux, M. Mathonnet, G. Luc,
S. Oustric, L. Samson, M.-V. Savary, O. Scatton, K. Slim, R. Souche, A. Valverde, C. Zaranis
Jury (in alphabetical order)
S. Auvray, J.M. Bruel, P. Chevalier, J. Gugenheim, F. Guillon, R. Nicodeme, G. Pelletier,
O. Raspado, B. Millat

Current status
Introduction
Nearly 120,000 cholecystectomies are performed each year in France (PMSI 20101 ), of
which 8590% are performed laparoscopically. Injuries to the bile ducts are the most feared
complication of this commonly performed procedure, which is generally considered as a
safe and benign intervention. The risk becomes a signicant concern because the large
number of cholecystectomies performed each year multiplies the severity of this rare
complication. This led the Federation for Visceral and Digestive Surgery (FCVD) to choose
this as the theme of its annual meeting in 2013 (Journe de la FCVD).

E-mail address: kslim@chu-clermontferrand.fr

PMSI: Programme de mdicalisation des systmes dinformation = the French DRG system.

http://dx.doi.org/10.1016/j.jviscsurg.2014.04.003
1878-7886/ 2014 Elsevier Masson SAS. All rights reserved.

242

Data from the literature

A review of the literature found nearly 2000 publications on
this subject in various databases. The French Association of
Surgery (AFC) has published several reports (most recently
in 2011). Like other complications that occur infrequently
and whose risk is considered low, objective assessment of
biliary injury requires cohort studies assessing thousands
of patients. The mean risk of biliary injury is estimated
at 0.5% after laparoscopic cholecystectomy with extremes
in published reports ranging from 0.1 to 1.5% (references
available on request). Interpretation of this variation in risk
reported in different studies requires consideration of the
study period and the denition of biliary injury (in some
studies, minor wounds particularly of the cystic duct, are not
included). While the risk of biliary injury during cholecystectomy has increased with the introduction of laparoscopic
cholecystectomy, this risk has decreased in recent years to
stabilize around 0.5% in most recent studies. When ductal
injury occurs during laparoscopy, the wound is often of a
more serious type such as complete transection, high ductal injury at the level of the bifurcation, or resection of a
segment of the common bile duct (references on request).
Associated vascular injury, a feared complication, occurs in
nearly a fourth of cases and remains a risk factor of poor
prognosis because it negatively impacts the post-operative
course and the results of any biliary reconstruction (references on request). Bile duct injury is recognized at the time
of surgery in only one-fourth of cases. Intra-operative recognition is a good prognostic factor (references on request)
because it allows prompt repair before inammatory or septic challenges can intervene. The role of cholangiography
in the prevention or detection of bile duct injury has been
evaluated in several cohort studies with large numbers of
patients; the conclusions of these studies are sometimes
conicting regarding the role of cholangiography as the sole
method to minimize the risk (references upon request).
Routine performance of operative cholangiography would
result in the detection of only one bile duct injury per 500
cholecystectomies. But most of these studies nevertheless
concluded that cholangiography was useful in preventing
major ductal injury. The value of cholangiography demands
that the surgeon have the prerequisite ability (with prior
training) to accurately interpret the cholangiogram.
Finally, when the timing of cholecystectomy for acute
cholecystitis is studied, (references upon request), the number of patients was not large enough to show a signicant
difference in the risk of bile duct injury between emergency
versus delayed intervention.

Analysis of the REX database

Analysis of the REX database identied 811 biliary ductal injuries that occurred during the years 20092012.
Among all the cases where failure to identify of the
cystic duct during cholecystectomy was identied, the
incidence of bile duct injury after cholecystectomy (depending on the year) was 916% for cholecystectomy for simple
cholelithiasis, 2222.5% for early intervention for acute
cholecystitis, and 4244% for delayed cholecystectomy for
acute cholecystitis. When all bile duct injuries are considered, the majority of them (5264%, depending on the
year) occurred during delayed cholecystectomy for acute
cholecystitis. But since the REX database is neither a registry nor an epidemiological database, these data must be
interpreted with caution. The causal relationship between

FCVD Guidelines
delayed cholecystectomy for acute cholecystitis and bile
duct injury needs to be evaluated by large-scale studies
(the current literature does not provide an answer to the
question with a good level of evidence).
The analysis of the relationship between bile duct injury
and intra-operative cholangiography showed that among the
251 ductal injuries, 65 occurred without intra-operative
cholangiography while 186 were associated with cholangiography (although it is not known whether the cholangiography
was performed before or after the bile duct injury to conrm
and dene the wound).

Proposed solutions
Synthesis of current knowledge
Proposed measures to improve patient safety were developed primarily for laparoscopic cholecystectomy (which is
performed in the vast majority of cases). We have excluded
from these proposed safety measures cholecystectomy performed by techniques currently undergoing evaluation, that
is to say by monotrocar, by trans-organ approaches, or with
robotic assistance.
In the accreditation process, the FCVD focused on failure to identify the cystic duct during cholecystectomy as
a major risk factor for bile duct injury. Data from the REX
database and from the literature were utilized to organize
of a national one-day meeting focused on the topic of risk
management for avoidance of bile duct injury during cholecystectomy.

Proposed solutions
The 2013 National Journe of the FCVD was organized
around this theme: a working group was formed in late 2012
and produced a paper that was distributed to a jury and to
participants at the meeting.
The literature review was summarized by a working
group and by interactive discussion among participants at
the Journe nationale de la FCVD on March 23rd, 2013,
with further discussion by a jury, which met in plenary
session on May 25th, 2013 to elaborate a consensus text.
The Scientic and Professional Commission of the FCVD
approved the nal text (see Composition of the organizational and work groups and of the Jury). Proposed
measures were classied into three categories: prevention,
recovery, and remediation. Recommendations were also
developed for texts to provide information to the patient
(Table 1).

Preventing the risks of bile duct injury

Organizational prerequisites
Primary preventive measures to reduce risk has always
included the caveat that cholecystectomy should be performed only for symptomatic gallstones according to the
recommendations of the HAS (http://www.has-sante.fr/
portail/upload/docs/application/pdf/2013-03/points-cle
solution - qd faire cholecystectomie.pdf).
The operative checklist should verify that all laparoscopic
equipment is present and in good condition, including verication that coagulation instruments are sheathed to prevent
electrical burns of the bile ducts. The materiel for cholangiography should be at hand and veried before surgery

Risk management to decrease bile duct injury associated with cholecystectomy

Table 1

Summary of patient safety measures.

Prevention
Organizational prerequisites
Indications for cholecystectomy
Operating room checklist
Tray of laparotomy instruments available if
conversion is required
Operative management of acute cholecystitis
Organized training of surgical competence,
particularly in the interpretation of
cholangiography
Technical prerequisites
Standard rules for dissection
Routine performance of cholangiography
Operative response
Detection of biliary injury: intra-operative
cholangiography
Indications for conversion to laparotomy
Under what circumstances should the biliary injury be
immediately repaired or a decision made to
transfer the patient to a specialized center
Remediation
Intra-operative diagnosis and management
Post-operative management of bile duct injury
Declaration of the incident
Full description in the dictated operative report
Pre-operative information of risks to the patient for
operative consent
Full information to the patient of any intra-operative
incident

(including the uoroscopy unit, choledochoscope, and tools

required for cannulation of the cystic duct).
Verication of the availability of a tray of laparotomy
instruments if conversion becomes necessary due to intraoperative difculties.
Routine positioning of the patient on the operating table
in anticipation of cholangiography.
In case of acute cholecystitis (without organ failure),
cholecystectomy should ideally be performed within the
rst 72 hours of symptom onset (not admission). Any
other management approach (delayed surgery, temporary
contra-indications, modalities of treatment) should be a
coordinated and planned decision.
Organization of surgeon training in interpretation of
cholangiographic images: the images should be inspected
centripetally identifying the segmental branches of the right
hepatic duct and following them down to the extrahepatic
common bile duct. Cholangiographic ndings should be fully
described in the operative report.

Technical prerequisites
When cholecystectomy is performed using three trocars, the
addition of a fourth trocar is recommended if there are difculties of exposure.
The dissection of the triangle of Calot should be pursued
in close contact with the gallbladder; identication of the
cystic duct lymph node aids in identication and exposure
of the cystic duct and verication that it is well away from
the common bile duct.
No structure should be clipped or cut until all the anatomical structures have been recognized and identied.

243

Bipolar coagulation is preferred to monopolar coagulation in the vicinity of the hepatic pedicle; if monopolar
cautery is used, it should be set at a low power setting.
The use of ultrasonic dissectors is controversial and no recommendation can be made on this subject.
Performance of routine intra-operative cholangiography
is an important standard that can be considered as quality
assurance for cholecystectomy. It must be performed as
soon as the cystic duct is identied and before transection of
any structure. Cholangiography does not prevent bile duct
injury in every instance, but it reduces the incidence and
severity of major bile duct injuries or allows their recognition intra-operatively. While the use of cholangiography
is not a panacea, its use by the health care team must be
included in the broader context of risk management including all elements of prevention and detection mentioned
above.
When cholangiography is not performed, the reasons
should be explained in the operative report.
In cases where dissection and identication of the critical
anatomical structures are difcult, particularly with severe
acute cholecystitis, it is not unreasonable to perform subtotal cholecystectomy leaving the gallbladder neck in place;
inability to identify the cystic duct or to perform cholangiography may be considered as prudent grounds for conversion
to a laparotomy approach.

WHAT MUST BE AVOIDED?

Excessive traction on the gallbladder neck
Transection of an unidentied anatomical element
Omission of intra-operative cholangiography in
case of difculties

Operative measures for bile duct injury and

remediation
Intra-operative response
Any leakage of bile into the operative eld, whether at the
level of the hepatic pedicle or the gallbladder bed, should
be considered suspicious and lead to the performance of
cholangiography or conversion to laparotomy.
One should not hesitate to convert from laparoscopy to
laparotomy when faced with intra-operative difculties with
lack of recognition or identication of the various biliary
structures.
A biliary ductal injury, once recognized intra-operatively,
must be assessed in terms of severity: which bile duct? At
what level of the biliary tree? Condition of the ductal wall
(clean transection or cautery necrosis)? Condition of the
hepatic pedicle (inammation)? Presence or absence of an
associated arterial lesion? The most comprehensive classication is that of the EAES.2
If there is the least doubt, conversion to laparotomy is
recommended.
Repair of bile duct injuries depends on the level of expertise of the surgeon in hepatobiliary surgery.
In the absence of surgical expertise for a particular type
of bile duct injury, it is recommended that an abdominal
2 EAES: European Association for Endoscopic Surgery. A Fingerhut
et al. Classication ATOM. Surg Endosc 2013.

244
drain be placed allowing the patient to be transferred to a
center of expertise to assure continuity of care.
The technique of ductal repair depends on the type of
injury; this may range from simple suture closure of a ductal
wound to ligation (or drainage) of a segmental branch, or
even to a bilio-digestive anastomosis.

Post-operative remediation
Post-operative bile duct injury should be suspected if symptoms of pain or sepsis arise post-operatively, particularly
with associated abnormalities of liver function tests.
If the patients clinical condition allows, accurate assessment must be based on morphological examination: prompt
performance of a CT scan to detect an intra-abdominal collection (which would require drainage) and biliary mapping
based on MRI-cholangiography or endoscopic opacication
(ERCP).
Treatment depends on the specic biliary injury and will
be decided on a case-by-case basis by a multi-disciplinary
team.
If bile duct injury is not well tolerated clinically,
emergency drainage of the septic intra-abdominal collection an/or the biliary tract (naso-biliary tube placed

FCVD Guidelines
endoscopically) is recommended with postponement of the
repair of the ductal injury.

Declaration of the incident

The potential gravity of bile duct injuries requires that
the patient be informed of the low but nite risk preoperatively.
Any intra-operative incident that requires modication
of the surgical procedure (drain placement, conversion to
laparotomy) or that may alter the post-operative management must be reported to the patient.
Such incidents must be noted in the operative report.
A precise description of the bile duct injury (according to
the established classication) is recommended when patient
transfer is required.

Disclosure of interest
The authors declare that they have no conicts of interest
concerning this article.