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The SAGES Safe Cholecystectomy Program

sages.org/safe-cholecystectomy-program

Strategies for Minimizing Bile Duct Injuries: Adopting a

Universal Culture of Safety in Cholecystectomy
Over 750,000 cholecystectomies are performed each year in the United States.1, 2
Patients benefit from reduced pain, faster return to normal activities, and reduced risk
of surgical site infection with a laparoscopic approach compared to an open
operation.3

The Problem
Bile duct injury rates have increased since the introduction of laparoscopic
cholecystectomy, occurring in about 3 per 1,000 procedures performed.4
Bile duct injuries after cholecystectomy can be life altering complications leading to
significant morbidity and cost.5, 6
Because bile duct injuries are relatively infrequent, definitive studies comparing
methods to minimize these complications will likely never be performed.

The following are 6 suggested strategies surgeons can employ to adopt a

universal culture of safety for cholecystectomy to and minimize the risk of bile
duct injury.*

1. Use the Critical View of Safety (CVS) method of identification of the cystic duct
and cystic artery during laparoscopic cholecystectomy.7

Three criteria are required to achieve the CVS:

A. The hepatocystic triangle is cleared of fat and fibrous tissue. The
hepatocystic triangle is defined as the triangle formed by the cystic duct, the
common hepatic duct, and inferior edge of the liver. The common bile duct and
common hepatic duct do not have to be exposed.
B. The lower one third of the gallbladder is separated from the liver to
expose the cystic plate. The cystic plate is also known as liver bed of the
gallbladder and lies in the gallbladder fossa.
C. Two and only two structures should be seen entering the gallbladder.

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 Critical
view of
safety
posterior
view

Critical
view
of
safety
anterior
view

Confirming the CVS – the CVS can be confirmed using a Doublet View.8 The Doublet
View has two components:

Visualization
of the
doublet
view Visualization of
(anterior) the doublet
view (posterior)

The doublet view anterior and posterior laparoscopic images visually demonstrate the three
components of the critical view of safety.

2. Consider an Intra-operative Time-Out during laparoscopic cholecystectomy prior

to clipping, cutting or transecting any ductal structures.

The Intra-operative Time-Out should consist of a stop point in the operation to

confirm that the CVS has been achieved utilizing the Doublet View.

3. Understand the potential for aberrant anatomy in all cases.

Aberrant anatomy may include a short cystic duct, aberrant hepatic ducts, or a right
hepatic artery that crosses anterior to the common bile duct.9 These are some but
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 not all common variants.

4. Make liberal use of cholangiography or other methods to image the biliary tree
intraoperatively.

Cholangiography may be especially important in difficult cases or unclear anatomy.

Several studies have found that cholangiography reduces the incidence and extent of
bile duct injury but controversy remains on this subject.10

5. Recognize when the dissection is approaching a zone of significant risk and halt
the dissection before entering the zone. Finish the operation by a safe method other
than cholecystectomy if conditions around the gallbladder are too dangerous.

In situations in which there is severe inflammation in the porta hepatis and neck of the
gallbladder, the CVS can be difficult to achieve. The sole fact that achieving a CVS
appears not feasible is a key benefit of the method since it alerts the surgeon to
possible danger of injury.
The surgical judgment that a zone of significant risk is being approached can be
made when there is failure to obtain adequate exposure of the anatomy of the
hepatocystic triangle or when the dissection is not progressing due to bleeding,
inflammation or fibrosis.
Consider laparoscopic subtotal cholecystectomy or cholecystostomy tube placement,
and/or conversion to an open procedure based on the judgment of the attending
surgeon.

6. Get help from another surgeon when the dissection or conditions are difficult.

When it is practical to obtain, the advice of a second surgeon is often very helpful
under conditions in which the dissection is stalled, the anatomy is unclear or under
other conditions deemed “difficult” by the surgeon.

*Note: These strategies are based on best available evidence. They are intended to make
a safe operation safer. They do not supplant surgical judgment in the individual patient. The
final decision on how to proceed should be made by the operating surgeon, according to
his/her experience and judgment.

References
1. Hurley V, Brownlee S. Cholecystectomy in California: A Close-Up of Geographic
Variation. California Healthcare Foundation 2011.

2. MacFadyen BV, Jr., Vecchio R, Ricardo AE, Mathis CR. Bile duct injury after
laparoscopic cholecystectomy. The United States experience. Surgical Endoscopy 1998;
12:315-21.

3. Keus F, de Jong JAF, Gooszen HG, van Laarhoven CJHM. Laparoscopic versus open
cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Database of
Systematic Reviews 2006:CD006231.

4. Buddingh KT, Weersma RK, Savenije RA, van Dam GM, Nieuwenhuijs VB. Lower rate of
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major bile duct injury and increased intraoperative management of common bile duct
stones after implementation of routine intraoperative cholangiography. Journal of the
American College of Surgeons 2011; 213:267-74.

5. Kern KA. Malpractice litigation involving laparoscopic cholecystectomy. Cost, cause, and
consequences. Archives of Surgery 1997; 132:392-7; discussion 7-8.

6. Flum DR, Flowers C, Veenstra DL. A cost-effectiveness analysis of intraoperative

cholangiography in the prevention of bile duct injury during laparoscopic cholecystectomy.
Journal of the American College of Surgeons 2003; 196:385-93.

7. Strasberg SM, Brunt LM. Rationale and use of the critical view of safety in laparoscopic
cholecystectomy. Journal of the American College of Surgeons 2010; 211:132-8.

8. Sanford DE, Strasberg SM. A simple effective method for generation of a permanent
record of the Critical View of Safety during laparoscopic cholecystectomy by intraoperative
“doublet” photography. Journal of the American College of Surgeons 2014; 218:170-8.

9. Strasberg SM. A teaching program for the “culture of safety in cholecystectomy” and
avoidance of bile duct injury. Journal of the American College of Surgeons 2013; 217:751.

10. Traverso LW. Intraoperative cholangiography reduces bile duct injury during
cholecystectomy. Surg Endosc 2006;20:1659-1661.

Keywords: safe chole, safe cholecystectomy, critical view of safety, safety in

cholecystectomy, culture of safety

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