Critical View of Safety Minimizes Risk of Bile Duct Injury

With 750,000 to 1 million laparoscopic cholecystectomies (LCs) performed in the US each year, the procedure is one of the most commonly performed operations and considered the gold standard for removing a troublesome gallbladder.¹

While complications, specifically bile duct injuries (BDIs), are rare, occurring in approximately 3 per 1,000 procedures performed, the rates have increased since the widespread use of LCs began in the early 1990s.² These cases are unsettling for both patients and surgeons alike—specifically because LCs are so widely performed and complications are, therefore, relatively unexpected.

“Cholecystectomy is obviously at the very core of general surgery,” said Brendan C. Visser, MD, FACS, professor and chief in the section of hepatobiliary and pancreatic surgery at Stanford University School of Medicine in California. “It’s supposed to go smoothly—but it can also be a very difficult inflammatory situation that is then a hard problem to solve. This is the type of operation where people, if it doesn't go well, are quick to ascribe blame, but nobody ever gets a pat on the back for a cholecystectomy that's well performed even in a difficult setting.”

BDIs can potentially lead to diminished quality of life or death for some patients and is a situation that can leave the surgeon feeling powerless if they have to turn the patient over to someone else because they lack the skills to remedy the nicked or burned bile duct.

“It’s that sense of ‘How could it happen—and now I'm powerless to solve it,’” explained Dr. Visser. “This situation could leave surgeons feeling vulnerable and lead them to question their own skill set or judgment because it's not supposed to happen.”

Typically performed as an outpatient procedure, LCs usually result in a quick return to full activity with minimal pain and overall excellent outcomes. However, patients experiencing an adverse complication like a BDI could potentially face an altered life trajectory. Specifically, these patients may need to endure numerous re-interventions/hospital visits, not to mention the potential for both short- and long-term mortality as high as 20.8%, an increase of 8.8% above the cohort’s expected age-adjusted rate of death.³

“I had a couple of bile duct injuries very early in my career in the early 1990s when laparoscopic cholecystectomies first started,” said L. Michael Brunt, MD, FACS, director of the Department of Surgery’s Section of Minimally Invasive Surgery at Washington University School of Medicine in St. Louis, Missouri. “Fortunately, the patient outcomes were good, but it certainly affected me emotionally for a considerable period of time. This is something that you'll never forget, and the transition to practice for surgeons, even if they've done fellowship, is still a difficult and challenging one.”

Dr. Brunt served as president of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 2014–2015, during which he initiated and subsequently chaired the SAGES Safe Cholecystectomy Task Force. This group developed evidence-based recommendations for safe cholecystectomy and the prevention of BDIs titled, “Safe Cholecystectomy Multi-Society Practice Guideline and State of the Art Consensus Conference on Prevention of Bile Duct Injury During Cholecystectomy.”

Subject matter experts from five top surgical societies—SAGES, Americas Hepato-Pancreato-Biliary Association, International Hepato-Pancreato-Biliary Association, Society for Surgery of the Alimentary Tract, and European Association of Endoscopic Surgery—generated recommendations based on systematic literature reviews. Consensus was reached on 17 questions organized into six broad topics around cholecystectomy, including anatomic identification techniques, disease factors, surgical techniques, surgeon education, and intraoperative management of injury.¹

Some of the key recommendations focus on the best use of intraoperative biliary imaging, indications on when to refer patients with a confirmed or suspected BDI to an experienced surgeon, and what the preferred approach is for ductal identification.

“The first question in the document states that the ‘Critical View of Safety’ is the preferred method for ductal identification during a laparoscopic cholecystectomy,” said Dr. Brunt. “If there is one thing that surgeons can do in their individual practice to minimize the risk of BDI, it would be to understand and apply the Critical View of Safety on every case when possible.”

Three criteria are required to achieve Critical View of Safety: Clear the hepatocystic triangle and fibrous tissue, separate the lower third of the gallbladder from the liver, and identify two (and only two) structures connected to the gallbladder.²

“One of the things that's very interesting about videos of LCs in which bile duct injuries have occurred is they look very similar case after case after case,” said Dr. Brunt. “You can see that obviously there’s been a misappreciation of the anatomy. There’s no critical view that's been obtained—and that’s why other methods of identification, such as the infundibular technique, are considered a significant error trap.”

The recommendations also suggest surgeons conduct “a momentary pause to confirm the criteria for Critical View of Safety has been attained before clipping or transecting ductal or arterial structures.”

“We don’t use this enough in surgery—take an intraoperative pause before you burn your bridges at any given point in an operation,” added Dr. Brunt. “For cholecystectomies, before you clip and cut the cystic duct and artery, take a step back and take a fresh look in order to reassure yourself that, ‘Yes, this looks right, what I'm looking at is correct.’” The other essential point is that when it’s not possible to obtain the Critical View of Safety due to inflammation, or because the hepatocystic triangle cannot be safely dissected, then the approach should be altered, preferably to subtotal cholecystectomy either laparoscopic or open.

You’ve Encountered a BDI—Now What?

BDIs often occur due to a failure in correctly identifying the patient’s anatomy. Some experts have suggested that approximately half of all patients have typical anatomy of the extrahepatic ducts, which means the other half could have anatomic variations due to a variety of factors.⁴

With this in mind, surgeons routinely take the necessary precautions, including planning for difficult cases with intraoperative imaging and engaging in the Critical View of Safety during the procedure.

Unfortunately, BDIs can still occur, and the operating surgeon should not hesitate to stop the procedure, and depending on the case, transfer the patient to a colleague with experience in BDI repair.

“The operating surgeon should be able to say that ‘We’re 48 hours post-op and I don’t like what I’m seeing in this clinical situation,” said Dr. Visser. “I need help. I want to get this patient evaluated or transferred to a center that has the ability to get it repaired in an expeditious fashion, which will diminish the length of the episode, the costs, and the morbidity for the patient.”

Dr. Visser described some key “principles of repair” for BDIs. In the preoperative stage, the surgeon should conduct a complete diagnosis of the extent of the injury and engage in “conservative timing” (or delayed repair) in the face of uncertainty and insufficient data regarding, for example, inflammation or drainage. At the intraoperative stage, surgeons should localize all ducts, trim to healthy duct, and engage in a “meticulous biliary enteric anastomosis technique, with side-to-side anastomosis [Hepp-Couinaud technique] where possible.”⁵

He also explained that preoperatively, it’s critical that surgeons understand what they’re getting into. “And what I mean by that is you have to delineate the nature and extent of the injury, both to the duct itself and regarding the possibility that there may be a vascular injury that’s associated with it. You have to be able to know confidently that when you’re in the operating room that you’re prepared for the problem that you face.”

A topic within the principles of repair that continues to generate debate among surgeons is the issue of when to operate: early versus late BDI repair.

Dr. Visser suggested that the early repair of BDIs (within 4 or 5 days typically) is warranted only if the patient is stable and medically optimized, is free of acute inflammation, and did not suffer vascular injury during the initial LC procedure. The justification for a delayed repair approach includes a delay in recognizing the situation by the initial surgeon, a delay in transfer to an appropriate center, time needed to completely characterize and drain the complex injury, and the presence of vascular injury.

“Both sides of the debate are trying to strike a balance between two opposite motivations,” said Dr. Visser. “One approach is motivated by the desire to solve the episode for the patient in order to return them to their pre-cholecystectomy health as quickly as is feasible. And the motivation for the delayed repair is sometimes practical and often unavoidable—to make sure that the inflammatory process and degree of injury has fully demarcated itself to the point that the repair will be the best durable long-term repair.”

The principles of repair apply to both early and delayed repair. Considerations for delayed repair could include additional financial costs to the patient and healthcare system, as well as diminished quality of life, including issues related to mental health well-being.

“This debate will never quite go away,” Dr. Visser said. “I think there are reasons to try to get repairs in early, and there are very strong reasons to delay in other circumstances and it’s always a question of judgment for the individual case and which is the better pathway, given that there are downsides and upsides to both approaches.”

Robotic-Assisted Cholecystectomy and BDI Repair

Due to the enhanced precision and dexterity enabled by this technology, robotic-assisted cholecystectomy and BDI repair are feasible approaches that feature smaller incisions, reduced pain, and quicker recovery times.

“Robotic-assisted procedures are done increasingly frequently across the spectrum of general surgery, and that includes cholecystectomy,” said Dr. Brunt. “There's no reason per se that the robotic approach should have a higher rate of injury except, perhaps, during the learning curve. But I think the most important thing is that these recommendations and principles, such as the Critical View of Safety, don’t change whether you are doing this laparoscopically or robotically.”

Dr. Visser noted that there is a smaller number of surgeons that have both experience in BDI repair and a robotic surgery skill set.

“I'm a surgeon who does complex operations robotically, and I find it to be a useful tool,” he added. “I think there absolutely is an appropriate application of the robot to repair bile duct injuries, but I think the application of this technology should always fall back on those same principles of repair. I do see videos of surgeons who are getting there with the robot and thinking that, because its minimally invasive, the rules don’t quite apply.”

While the benefits of robotic surgery have been demonstrated—including the enhanced ability for surgeons to navigate around a heavy abdominal wall in high-BMI patients—studies comparing the safety and efficacy of LCs and the robotic-assisted approach seem to indicate the latter continues to be an evolving intervention.

A study published in 2023 examining a decade’s worth of outcomes (2010–2019) from Medicare claims data revealed that robotic-assisted cholecystectomy was associated with an increased risk for BDI (0.7% versus 0.2%), and overall rates of postoperative biliary interventions were significantly higher in patients undergoing robotic-assisted cholecystectomy.⁶

More recently, an article published in January 2025, also analyzed BDI rates for Medicare patients (n = 737,908) who underwent laparoscopic or robotic cholecystectomy for an additional 2 years (2010–2021). Investigators found BDI rates to be significantly higher for robotic-assisted procedures, while outcomes and readmission rates were found to be similar for both LCs and robotic-assisted cases.⁷

In an editorial that accompanied the 2023 study, Dr. Brunt emphasized the importance of the Critical View of Safety and other recommendations and noted the use of intraoperative cholangiography and near-infrared imaging technology are potentially beneficial adjuncts to robotic-assisted cholecystectomy.

“I don't believe that robotics will increase the risk of duct injuries,” said Dr. Visser. “I think early publications that suggest this may be the case is due to the fact that surgeons are using the robot on the most complex gallbladders, which could elevate the risk of BDIs. I think the vision and stabilization that are afforded by the robot will likely contribute to reducing bile injuries with time.”

Discussing BDI with Patients

When a BDI occurs, it is recommended that surgeons communicate honestly and compassionately with the patient and their family, explaining that BDIs are a known complication that can be unavoidable even in skilled hands, and provide detailed information regarding potential treatment pathways and any anticipated risks.

“We should speak with sympathy in our voices about the patient’s situation, but also honestly about the operating surgeon’s situation who participated in that original cholecystectomy,” advised Dr. Visser. “And speaking in a way that is not dishonest yet sympathetic sets a tone where the patient feels they are truly being cared for and that this is not about ascribing blame.”

Surgeons, who are typically expected to project confidence with their patients, should avoid projecting a level of self-assurance that could imply that—because they are responsible for fixing someone else’s error—they are somehow better than the operating surgeon.

“It’s very easy to slip into that language unintentionally if you’re not consciously doing the reverse,” said Dr. Visser. “I think you should speak about it as a situation that makes your heart ache, but that it is, in fact, fixable and that is why you’re here, and we’re going to do everything we can to make sure this episode is as short as possible and, ultimately, results in no long-term challenges for the patient.”

Developing a culture of trust and empathy for patients with a BDI also should involve intentional mentoring of residents and other trainees.

“From the very beginning, when we accept a patient transfer, the residents understand that communication for bile duct injuries has to come from the top down and that their directive is not to speculate or answer questions,” Dr. Visser said. “They are informed that the language we use to speak to each other and the patients—and that we use in the charts—should not imply causality or fault. We were not present for the operation as it occurred and that it is not for us to judge what was done or if there were opportunities to do something differently. I think this approach can really assuage what otherwise might be a growing sense of anger in the patient in terms of ‘How could this happen to me?’”

Peer Support Can Ease Feelings of Inadequacy

While BDIs are statistically low-frequency events, they nonetheless occur with some regularity due to the high frequency of the cholecystectomy. These events can be devastating even for surgeons well beyond the learning curve.

“All surgeons have been through serious adverse events, and we should not adopt a mindset of feeling like you have to bear the burden all on your own,” Dr. Brunt said, adding that most institutions have robust peer support programs designed to help surgeons overcome feelings of powerlessness and self-doubt.

“Every time there is a complication like this it leaves scars on the heart of the operating surgeon,” said Dr. Visser. “It is important to advocate for the patients, but it is also important to give the operating surgeons a little bit of grace in how we talk about these events. I think we’re at a good time in human history to actually be sympathetic to our colleagues and partners and friends when these injuries occur.”

Tony Peregrin is the Managing Editor of Special Projects in the ACS Division of Integrated Communications in Chicago, IL.

References

1. Brunt LM, Deziel DJ, Telem DA, Strasberg SM, et al. Safe Cholecystectomy Multi-Society Practice Guideline and State of the Art Consensus Conference on Prevention of Bile Duct Injury During Cholecystectomy. Ann Surg. 2020;272(1):3-23.
2. Society of Gastrointestinal and Endoscopic Surgeons. The SAGES Safe Cholecystectomy Program. Available at: https://www.sages.org/safe-cholecystectomy-program/ Accessed April 3, 2025.
3. Halbert C, Altieri MS, Yang J, Meng Z, et al. Long-term outcomes of patients with common bile duct injury following laparoscopic cholecystectomy. Surg Endosc. 2016;30(10):4294-4299.
4. Frangou C. Program targets bile duct injuries from lap chole. General Surgery News. July 27, 2017. Available at: https://www.generalsurgerynews.com/In-the-News/Article/07-17/Program-Targets-Bile-Duct-Injuries-From-Lap-Chole/41836?ses=ogst. Accessed April 3, 2025.
5. Winslow ER, Fialkowski EA, Linehan DC, Hawkins WG, et al. "Sideways": Results of repair of biliary injuries using a policy of side-to-side hepatico-jejunostomy. Ann Surg. 2009;249(3):426-434.
6. Kalata S, Thumma JR, Norton EC, Dimick JB, et al. Comparative safety of robotic-assisted vs laparoscopic cholecystectomy. ^{JAMA Surg}. 2023;158(12):1303-1310. Editorial: Feldman LS, Brunt LM. New technology and bile duct injuries. JAMA Surg. 2023;158(12):1311.

7. Mullens CL, Sheskey S, Thumma JR, et al. Patient complexity and bile duct injury after robotic-assisted vs laparoscopic cholecystectomy. JAMA Netw Open. 2025;8(3):e251705.