The SAGES Safe Cholecystectomy Program

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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:
    1. 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.
    2. 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.
    3. Two and only two structures should be seen entering the gallbladder.

Safe Chole Figure 1A Critical view of safety anterior view

Critical view of safety anterior view

Safe Chole Figure 1B Critical view of safety posterior view

Critical view of safety posterior view

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

Safe Chole Figure 2A Documentation of the doublet view anterior

Visualization of the doublet view (anterior)

Safe Chole Figure 2B Documentation of the doublet view posterior

Visualization of 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 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 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