Strategies for Minimizing Bile Duct Injuries during cholecystectomy are founded in a Patient Safety Mindset, ensuring proper clearing of the surgical field, careful identification of cystic structures, and confidence in surgical technique.

2. Horacio J. Asbun, MD, Jacksonville, FL, Professor of Surgery, Chairman, General Surgery, Mayo Clinic Florida (SAGES)
Jaap Bonjer, MD, PhD, Amsterdam, Netherlands, Professor of Surgery, VU University Medical Centre Amsterdam (EAES)
Michael Brunt, MD, Saint Louis, MO, Professor of Surgery, Section Chief, Minimally Invasive Surgery, Washington University
School of Medicine (SAGES)
Oscar C. Imventarza, MD, Buenos Aires, Argentina, Chairman, Liver & Transplant Division, Hospital Argerich-Hospital
Garrahan (IHPBA)
Rebecca M. Minter, MD, Saint Louis, MO, A.R. Curreri Professor and Chair of Surgery, University of Wisconsin School of
Medicine and Public Health (AHPBA)
Nathaniel J. Soper, MD, Chicago, IL, Loyal and Edith Davis Professor and Chair of Surgery, Northwestern Medicine (SSAT)
Dimitrios Stefanidis, MD, PhD, Indianapolis, IN, Professor of Surgery, Vice Chair of Education, Chief MIS/ Bariatric Surgery,
Indiana University School of Medicine (SAGES)
Steven Strasberg, MD, Saint Louis, MO, Pruett Professor of Surgery, Washington University in Saint Louis (AHPBA)
Charles Vollmer Jr., MD, Philadelphia, PA,Professor of Surgery, Director, Pancreatic Surgery, University of Pennsylvania
(AHPBA)

3. Rajesh Aggarwal, MD, PhD, Philadelphia, PA, Professor of Surgery, Thomas Jefferson University (SAGES)
Daniel J. Deziel, MD, Chicago, IL, Professor and Helen Shedd Keith Chair Emeritus, Department of Surgery, Rush
University Medical Center (SAGES)
William Jarnagin, MD, New York, NY, Chief, Hepatopancreatobiliary Service, Leslie Blumgart Chair in Surgery, Memorial
Sloan Kettering Cancer Center (IHPBA)
Keith Lillemoe, MD, Boston, MA, Surgeon-in-Chief and Chief of the Department of Surgery, ​Massachusetts General
Hospital (Member at Large)
Miguel Mercado, MD, Mexico City, Mexico, Director of Surgery, Instituto Nacional de Ciencias Medicas Y Nutricion
Salvador Zubiran (AHPBA)
Rowan Parks, Edinburgh, Scotland, Professor of Surgical Sciences, University of Edinburgh, Deputy Director of Medicine,
NHS Education for Scotland (IHPBA)
Taylor Riall, MD, PhD, Tucson, AZ, Professor of Surgery, Chief, Division of General Surgery / Surgical Oncology, University
of Arizona (SSAT)
Martin Smith, MB, BCh, Johannesburg, South Africa, Professor, Head, Department of Surgery, University of the
Witwatersrand (IHPBA)
Dana A. Telem, MD, Ann Arbor, MI, Associate Professor of Surgery, University of Michigan (SAGES)

6. •P – patient, problem or population
•I – intervention
•C – comparison, control or comparator[5]
•O – outcome

7. THE SAGES 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 States1, 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.

9. PICO 1: Should critical view of safety (CVS) vs other techniques (e.g. infundibular, top down, or
Intraoperative cholangiography) be used to mitigate the risk of bile duct injury during laparoscopic
cholecystectomy?

10. Critical view of safety anterior view
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.

11. The doublet view anterior and posterior laparoscopic images visually demonstrate the three components of the critical
view of safety.
•Confirming the CVS – the CVS can be confirmed using a Doublet View.8 The Doublet View has two
components:

12. PICO 1: Should critical view of safety (CVS) vs other techniques (e.g. infundibular, top down, or
Intraoperative cholangiography) be used to mitigate the risk of bile duct injury during laparoscopic
cholecystectomy?
Recommendation A: In patients undergoing laparoscopic cholecystectomy, we suggest that surgeons
use the critical view of safety (CVS) for anatomic identification of the cystic duct and artery.
(conditional recommendation, very low certainty of evidence)

13. PICO 2: Should the top down technique vs subtotal cholecystectomy be used to mitigate the risk of
bile duct injury when the CVS cannot be achieved during laparoscopic cholecystectomy?
Recommendation A: When the CVS cannot be achieved and the biliary anatomy cannot be clearly
defined by other methods (eg imaging) during laparoscopic cholecystectomy, we suggest that surgeons
consider subtotal cholecystectomy over total cholecystectomy by the top down approach. (conditional
recommendation, very low certainty of evidence)

14. PICO 3: How should the CVS be documented during laparoscopic cholecystectomy (still doublet photos
vs operative notes vs video vs no documentation)?
Recommendation A: When performing laparoscopic cholecystectomy, we suggest that surgeons
incorporate documentation of the critical view of safety by doublet photography or video in addition to
written documentation. (conditional recommendation, very low certainty of evidence)

15. PICO 4: Should intraoperative biliary imaging (e.g. intraoperative cholangiography, US) vs no
intraoperative biliary imaging be used for mitigating the risk of bile duct injury during laparoscopic
cholecystectomy?
Recommendation A: In patients with uncertainty of biliary anatomy or suspicion of bile duct injury
during laparoscopic cholecystectomy, we recommend that surgeons use intraoperative biliary imaging
(in particular intraoperative cholangiography) to mitigate the risk of bile duct injury (strong
recommendation, low certainty of evidence).
In patients with acute cholecystitis or history of acute cholecystitis, we suggest the liberal use of
intraoperative cholangiography during laparoscopic cholecystectomy to mitigate the risk of bile duct
injury (conditional recommendation, low certainty of evidence)
Surgeons with appropriate experience and training may use laparoscopic ultrasound imaging as an
alternative to IOC during laparoscopic cholecystectomy.

16. PICO 5: Should near infrared vs IOC or white light be used in mitigating the risk of BOI during
laparoscopic cholecystectomy?
Current evidence is insufficient to make a recommendation regarding use of near infrared
cholangiography for identification of biliary anatomy during cholecystectomy compared to
intraoperative cholangiography or white light. The evidence should be reassessed once results of the
large randomized trial become available (FALCON trial: NCT02702843)
Recommendations for future study/ type B recommendation:
Recommendation B: Near infrared cholangiography should be assessed in large trials compared to
white light and/or intraoperative cholangiography with risk stratification and risk adjustment. In
particular, this technology should be studied in difficult cholecystectomy patient populations that
includes those with acute cholecystitis or history of acute cholecystitis, severe chronic cholecystitis, and
obese patients.

17. PICO 6: Should surgical (complexity) risk stratification vs alternative or no risk stratification be used
for mitigating the risk of BOI associated with laparoscopic cholecystectomy?
Recommendation A1: We suggest that surgeons use the Tokyo Guidelines 18 (TG18) for grading and
management of patients with acute cholecystitis (conditional recommendation, low certainty of
evidence ).
Recommendation A2: During operative planning of laparoscopic cholecystectomy and intraoperative
decision-making, we suggest that surgeons consider factors that potentially increase the difficulty of
laparoscopic cholecystectomy (such as male gender, increased age, chronic cholecystitis, obesity, liver
cirrhosis, adhesions from previous abdominal surgery, emergency cholecystectomy, cystic duct stones,
enlarged liver, cancer of gallbladder and/or biliary tract, anatomic variation, biliodigestive fistula, and
limited surgical experience). (conditional recommendation, very low certainty of evidence)

18. PICO 7: Should risk stratification that accounts for cholecystolithiasis vs no/alternate risk stratification
be used for mitigating the risk of BOI associated with laparoscopic cholecystectomy?
A specific recommendation cannot be provided as no risk prediction models exist that incorporate the
presence or absence of gallstones as a factor that increases bile duct injury or difficulty of laparoscopic
cholecystectomy.

19. PICO 8: Should immediate cholecystectomy (within 72 hrs from symptom onset) vs cholecystectomy
performed 72 hours-10 days, 10 days- 6 weeks, >6 weeks be used for patients with acute
cholecystitis?
Recommendation A: In patients presenting with mild acute cholecystitis (according to Tokyo Guidelines),
we suggest surgeons perform laparoscopic cholecystectomy within 72 hours of symptom onset
(conditional recommendation, very low certainty of evidence)
For patients with moderate and severe cholecystitis there is insufficient evidence to make a
recommendation, particularly as it relates to the outcome of bile duct injury.

20. Recommendations for future study/ type B recommendation:
Recommendation B1: Studies that examine the relationship between bile duct injury and acute
cholecystitis should match patients at baseline both for severity grade of acute cholecystitis and history
of prior attacks of acute cholecystitis. This recommendation is based on the finding that the incidence
of major bile duct injury is significantly higher in moderate grade acute cholecystitis than in mild grade
acute cholecystitis and the finding that the incidence of bile duct injury is higher in patients who have
had prior attacks of acute cholecystitis than those who have not.
Recommendation B2: The diagnosis of acute cholecystitis should be documented in future studies
following well accepted clinical criteria such as TG18 diagnostic criteria or histologic findings of acute
inflammation or both. If documentation of acute cholecystitis is based on ICD codes, investigators
should ensure that the ICD codes were based on the preceding criteria.
Recommendation B3: In acute cholecystitis for the purposes of reporting standardization and ability to
compare results among studies, we suggest that the interval between onset of symptoms and time of
operation should be defined in 4 phases (Pl-4): PI: Symptom onset to 72 hrs; P2: 72 hours to 10 days;
P3: 10 days to 6 weeks; P4: > 6 weeks. We also recommend that studies define the onset of AC from
the onset of patient symptoms rather than from the arrival of the patient to the hospital

21. PICD 9: Should subtotal cholecystectomy vs total laparoscopic or open cholecystectomy be used for
mitigating the risk of BDI in marked acute inflammation or chronic biliary inflammatory fusion (BIF)?
Recommendation A: When marked acute local inflammation or chronic cholecystitis with biliary
inflammatory fusion (BIF) of tissues/tissue contraction is encountered during laparoscopic
cholecystectomy that prevent the safe identification of the cystic duct and artery, we suggest that
surgeons perform subtotal cholecystectomy either laparoscopically or open depending on their skill set
and comfort with the procedure (conditional recommendation, very low level of evidence )

22. PICD 10: Should standard 4-port laparoscopic cholecystectomy vs single-port/ single incision
laparoscopic cholecystectomy be used for mitigating the risk of BDI?
Recommendation A: For patients requiring cholecystectomy, we suggest using a multi-port laparoscopic
technique instead of single port/single incision technique (conditional recommendation, very low
certainty of evidence).

23. PICD 11: Should interval/delayed lap chole vs no additional treatment be used for patients previously
treated by percutaneous cholecystostomy?
Recommendation A: In low risk surgical candidates with acute calculous cholecystitis previously treated
by percutaneous cholecystostomy, we suggest interval cholecystectomy after the inflammation has
subsided. For high risk candidates, we suggest a non-surgical approach that may include percutaneous
stone clearance through the tube tract or tube removal and observation if the cystic duct is patent.
(conditional recommendations, very low certainty of evidence).

24. PICD 12: Should conversion of laparoscopic to open cholecystectomy vs no conversion be used for
mitigating the risk of BOI in the difficult laparoscopic cholecystectomy?
Current evidence is insufficient to make a recommendation in the difficult laparoscopic cholecystectomy
regarding conversion vs no conversion to open cholecystectomy to limit/avoid bile duct injury.
Recommendations for future study/ type B Recommendation:
Recommendation B1: We suggest the conduct of prospective and retrospective comparisons of clinical
outcomes of various 'bail-out' options for the difficult cholecystectomy that include conversion to open,
subtotal cholecystectomy, and procedure abandonment.
Recommendation B2: We suggest the development and establishment of valid evidence for a ‘procedure
difficulty score' for laparoscopic cholecystectomy.

25. PICO 13: Should a time out to verify the CVS vs no time out be used for mitigating the risk of BOI
associated with laparoscopic cholecystectomy?
Recommendation A: Current evidence is insufficient to make a recommendation. However, as best
practice, we suggest that during laparoscopic cholecystectomy, surgeons conduct a 'time-out' to verify
the appropriateness of the critical view before clipping or transecting ductal or arterial structures.
Recommendations for future study/ type B Recommendation:
Recommendation B: We suggest incorporation of a 'critical view time-out' in all prospective studies of
laparoscopic cholecystectomy.

26. PICO 14: Should two vs one surgeon(s) be used for mitigating the risk of BOI associated with
laparoscopic cholecystectomy?
Current evidence is insufficient to make a recommendation regarding two vs one surgeons for
limiting/avoiding bile duct injury in cholecystectomy.

27. PICO 15: Should CVS coaching of surgeon vs no coaching be used for mitigating the risk of BOI
associated with laparoscopic cholecystectomy?
Recommendation A: We suggest continued education of surgeons regarding the critical view of safety
during laparoscopic cholecystectomy that may include coaching. (Conditional recommendation, very
low certainty of evidence)

28. PICO 16: Should training by simulation or video-based education vs alternative surgeon training be
used for mitigating the risk of BOI associated with laparoscopic cholecystectomy?
Current evidence is insufficient to determine the benefit of simulation vs video-based vs alternative
surgeon training modalities on limiting/avoiding bile duct injury.
Recommendations for future study/ type B:
Recommendation B: We suggest the conduct of prospective large-scale multi-center studies to
determine the role of simulation vs video-based vs alternative surgeon training modalities on
limiting/avoiding bile duct injury.

29. PI CO 17: Should more vs less surgeon experience be used for mitigating the risk of BOI associated with
laparoscopic cholecystectomy?
Recommendation A: We suggest that surgeons have a low threshold for calling for help from another
surgeon when practical in difficult cases or when there is uncertain of anatomy (conditional recommendation, low
certainty of evidence).
Recommendation for future studies/Type B Recommendation:
Recommendation B: We suggest the conduct of prospective research studies to develop evidence-based
guidelines for physicians who are in transition in practice/from residency/fellowship to independent
practice, in order to mitigate the risk of BDI associated with laparoscopic cholecystectomy.

30. PICO 18: Should immediate reconstruction by the operating surgeon vs referral to a specialty center
be used for patients with BDI during cholecystectomy?
Recommendation A: When a bile duct injury (BDI) has occurred or is highly suspected at the time of
cholecystectomy or in the post-operative period, we suggest that surgeons refer the patient promptly to
a surgeon with experience in the management of BDI in an institution with a hepato-biliary disease
multispecialty team. When not feasible to do so in a timely manner, prompt consultation with a
surgeon experienced in the management of BDI should be considered. (strong recommendation, low
certainty of evidence)
Additional Panel Recommendation: Type B Recommendation
We suggest the development of national quality improvement initiatives for the prevention of bile
duct injuries following cholecystectomy. The initiatives(s) should be capable of identifying and
characterizing bile duct injuries in the population under study.

31. 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
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.

32. 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

33. 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