In December 2020, we ended the year with a debate on the best way to prevent common bile duct injury after cholecystectomy. The debate raised as many questions as it answered. General Surgery News received several responses from its readers, but two stood out from the rest and their stances have prompted a new debate. This new controversy addresses whether a still-debatable solution should be mandated to surgeons in some way.

Our debaters not only differ in their solutions to the problem of common bile duct injury, but how, and whether, any solution should be enforced. Because I believe the latter raises important ethical and political questions that we all need to face, we are continuing the debate on prevention of these injuries. How we as individual surgeons, as surgical societies, and the general public proceed in solving this important question is the subject of this month’s debate.

I am sure that you will find what each of our debaters is saying to be their honest opinion, but I am also sure you will pick a side to vehemently support. “Read ‘em and weep,” and don’t hesitate to carry on the debate. We surgeons need to be the ones guiding our future path, not some outside institution or enforcement body.

Guidelines for Avoiding Bile Duct Injury: Beware

I read with interest the Great Debate in the December 2020 issue of General Surgery News between Drs. L. Michael Brunt, Taylor S. Riall and Raul J. Rosenthal on the use of intraoperative cholangiography (IOC) to decrease major bile duct injury (BDI) during laparoscopic cholecystectomy. Dr. Brunt stated it should always be used; Dr. Rosenthal said we should always use fluorescent indocyanine green for IOC; and Dr. Riall said it best when she concluded her argument: “An individual surgeon’s algorithm in this challenging setting [anatomic clarity is not achievable] should be consistent and based on their expertise.”

I would like to broaden the discussion and talk about something Dr. Brunt mentioned in his argument: the multi-society practice guidelines and state-of-the-art consensus conference on the prevention of BDI during cholecystectomy. For those of you not familiar with this consensus conference, I urge all of you to read the lengthy manuscript (Ann Surg 2020;272[1]:3-23; Surg Endosc 2020;34[7]:2827-2855).

This consensus conference has been used, as Dr. Brunt used it for IOC, to advocate for certain practices during laparoscopic cholecystectomy. I applaud his efforts and the hard work of his committee to limit major BDI, but even he admits that most of the studies used to recommend routine IOC are of very poor quality. As Dr. Riall also pointed out, the evidence that the members of the conference used to recommend IOC had very low certainty. I’m only using this as one example, but it sets the stage for my concern. The rampant use of consensus conference panels and “guidelines,” as they are so innocently labeled, is out of control in our profession. These guidelines can create many issues for both practicing surgeons and surgical trainees, and I think this is especially true of the consensus conference on the prevention of BDI.

One cannot help but be amazed how “recommendations” can be made as they are in this 22-page manuscript by the consensus conference panel with such little evidence to support the recommendations. The panel describes 18 recommendations that they suggest surgeons should “possibly” do as part of their approach to laparoscopic cholecystectomy. They conclude the paper by admitting the quality of evidence is low—usually Level IV—for almost everything that was recommended.

More importantly, and what I see as dangerous, the authors say the guidelines—with very low level of evidence—will be disseminated and promoted on different society websites, through panel sessions at various meetings, translated for international audiences, and promoted through social media. Scarily, they say the guidelines should be distributed to hospitals, health care systems, health care plans, malpractice insurers and patient safety organizations. Finally, they say they will disseminate these guidelines into general surgery training programs throughout the world to influence the next generation of practicing surgeons. Unfortunately, some of this has already been done. As someone who performed the first laparoscopic cholecystectomy in my area and who, over the past 33 years, has performed around 5,000 of these procedures without a major BDI, and who regularly serves as an expert on such malpractice cases, I am very concerned about the dissemination of so-called guidelines as a consensus with very low to no level of evidence to support them.

I will cite a few examples. The first recommendation regards the critical view of safety (CVS) to mitigate BDI. The panel begins by saying there is no direct comparative evidence to support the CVS over other methods for anatomic identification during laparoscopic cholecystectomy, but they still recommend its use. Now, I am not here to criticize the CVS. However, there are many issues with the CVS, and when it becomes a “guideline,” since we know that lawyers and hospitals and others will equate it with the standard of care, which to them means the only way to do lap chole, and therein lies the issue. I have seen this many times in the majority of lap chole cases I have reviewed as an expert witness. The CVS is the favorite tool plaintiffs’ attorneys hold up as being the standard of care, and they believe it is the only way to expose the critical structures during lap chole.

This leads to the second recommendation of the panel that when the CVS cannot be achieved, laparoscopic subtotal cholecystectomy should be done over total cholecystectomy by the fundus-down approach either by a laparoscopic or open technique. As someone who has successfully done thousands of laparoscopic fundus-down or retrograde dissections in impossibly diseased gallbladders, I find it sad that what the panel recommends has a very low level of evidence. In fact, I write this after completing three lap choles today: Two of them had impossible chronically diseased gallbladders wherein no normal tissue planes were evident such that the triangle of Calot could not be safely dissected. However, with a lot of hard work and a retrograde approach, both cases were accomplished safely laparoscopically. If we had followed the guidelines of the committee, both of these patients would have had a suboptimal operation—such as subtotal cholecystectomy or fenestration—and be faced with long-term problems.

I will let the readers review the rest of the manuscript to see that this low level of evidence permeates most of the recommendations. This is not to say there is not plenty of information in the panel’s work, but as with most guidelines, the creators seem to ignore the serious weaknesses and plan to promote their recommendations as fact on a worldwide basis.

Laparoscopic cholecystectomy is a common operation and can be easy or extremely difficult, which is true for most surgical procedures. We all know that major BDI can be catastrophic for the patient and the surgeon. I applaud all the difficult work done by the committee in trying to make the procedure as safe as possible. I am not trying to say the information evaluated is not important, and I am not saying important information for the practicing surgeon does not result from these panels. It is the way this information is used, conveyed and disseminated that needs to change. The committee mentions some of these issues in their manuscript, but in their haste to seal in stone their recommendations based on flimsy evidence and to disseminate them widely, they seem to gloss over the fact that much work needs to be done to find out if their guidelines have any basis in fact. The rigidity, oversimplification, and what I see as a sort of arrogance in these recommendations and their inflexibility to entertain what goes on in the real world, may show the difference between the academic surgeon who does 10 to 20 lap choles a year and the practitioner in the real world who does 150 a year.

I work in two busy community hospitals where thousands of gallbladders are safely removed each year. There will always be the risk for BDI in lap chole—it is the nature of the beast. There is no such thing as a “never event”—don’t get me started on that idiotic phrase—when you are dealing with a complex human being with a diseased gallbladder and surgeons with varying experience and abilities. It is time to reel in the guideline madness for the benefit of all concerned.

Cholangiographic Activism

If the leaders of organized surgery are intent on reducing the number of bile duct injuries during laparoscopic cholecystectomy, they must take a novel approach. The silos of the congress/consortium/national meeting and focus group have kept emerging information among themselves. It is time to involve and effectively use the most important element of the equation: the patient.

Patients must become an activist group campaigning against bile duct injuries (BDIs), just as they have for other disease entities. They must become intraoperative cholangiography (IOC) activists. They must entreat their physicians to use IOC “on a routine basis.”

An increasing amount of peer-reviewed scientific data from around the world strongly suggest that routine IOC during laparoscopic cholecystectomy will:

• prevent biliary tract injuries^1-8;
• detect injuries to the biliary tract at the time of surgery; and
• lessen the consequences of a biliary tract injury by its detection at the time of surgery.

At this point, one still cannot say with clear and convincing scientific justification that performing IOC should be a requirement of the surgical standard of care. As other surgeons have pointed out, there is a difference between the surgical standard of care and what is advocated as safe and effective by researchers. “Standard of care,” a term loosely used at many surgical conferences, is a legal and not a medical term. A commonly accepted definition of standard of care means what a reasonable surgeon would do in the same or similar circumstance. Since approximately only 20% of surgeons employ routine IOC, it is illogical and untenable to state that 80% of the surgeons are violating the surgical standard of care by failing to perform this study.

Despite the increasingly convincing data that IOC detects and prevents injuries, the working surgeon, confident in the delineation of the biliary anatomy, is still legally within the standard of care if that surgeon does not routinely perform IOC.

Surgical leaders must go beyond the confines of the traditional methods of exchanging scientific information, and they must head in a new direction. Only then will a scientifically valid principle become an element of the surgical standard of care. Just as laparoscopic cholecystectomy became patient driven, so too should routine IOC. This is called cholangiographic activism.

A five-step program promoting the universal adoption of routine IOC as part of laparoscopic cholecystectomy may achieve this goal.

1. Surgical Education Programs

If surgical educators are convinced of the efficacy of the routine use of IOC in preventing BDIs, such use should become a required part of all surgical education programs. The professoriate and master educators should adopt this approach to institute the universal use of this technique by incorporating it into laparoscopic cholecystectomy training. Department chairs should require routine IOC during laparoscopic cholecystectomy within their departments. They must, through their instruction and supervision, make it a required part of the operation.

National organizations dedicated to surgical education, such as the Society of American Gastrointestinal and Endoscopic Surgeons, the American College of Surgeons and the Society for Surgery of the Alimentary Tract, must also publicly promote this concept.

2. The American Board of Surgery

It is the obligation of the American Board of Surgery to certify surgeons who are safe. If the members of the board are convinced that routine IOC is part of a safe surgeon’s activities, it is their ethical duty to promote routine IOC through the examination process.

If the board failed every candidate who did not perform an IOC procedure with every laparoscopic cholecystectomy, then every candidate would perform—or would say they would perform—this procedure in an examination situation. If the answer on the written exam and oral exam were to perform routine IOC, the seed would be planted among the candidates: that to pass the examination, that this is the only correct answer. Once it is known that the American Board of Surgery is convinced that the weight of scientific research favors IOC, examination candidates will respond appropriately.

3. Medical Liability Companies

Medical liability insurance companies are seeing an increased incidence of claims filed because of BDIs (personal communication, 2017).

The litigation costs of a BDI are significant. If one considers the filing of the case, the evaluation of a case by experts in the adjudication of the case, the average insurance company spends approximately $100,000 to $150,000 in case evaluation alone. Should the plaintiff prevail by settlement trial or arbitration, the typical judgment is about $300,000 or more, depending on the economic damages and gender. In states with no financial cap on pain, suffering and emotional distress, this number may be significantly increased.

Medical malpractice insurance companies should offer a tantalizing premium discount for all surgeons performing laparoscopic cholecystectomy.

4. Hospitals

Hospitals and medical centers, through their credentialing and reappointment processes, often bear part of the litigation expense for BDIs. If IOC becomes the standard of care for biliary surgery, it follows that they will be held partly responsible for such injuries. If hospital administrators are made aware of potential cost savings by avoiding payments or eliminating payments for BDIs, this will have a powerful effect on adopting its use.

By including a requirement that if laparoscopic cholecystectomy privileges are awarded to the applicant, IOC must be part of the procedure and IOC must be used at that particular hospital. The technology to perform IOC is already available in most hospitals.

Surgical leaders and master surgeon educators concerned with the BDI issue also should consider a bold move: lobbying state legislators to add BDI to the ever-growing list of “never events,” such as wrong-side surgery. Some of these events carry with them significant administrative monetary penalties for the hospital in which these cases arise.

5. The patient as an IOC advocate—IOC activism

If patients are made aware of the numerous scientifically proven benefits of IOC, they will start demanding it during their preoperative discussion with surgeons.

Patients are becoming increasingly sophisticated as they approach their procedures. As such, a direct appeal to the public by medical organizations will have a lasting effect on the adoption of routine IOC during laparoscopic cholecystectomy.

The adoption of routine IOC will re-create the dynamic that arose with the introduction of laparoscopic cholecystectomy in the first place. The circa 1990 query, “Do you do the new type of gallbladder surgery?” will now be replaced by, “Do you do the x-ray of my bile ducts during the operation?”

Cholangiographic activism may be historically viewed as the biliary equivalent of handwashing. Just as handwashing and the mass dissemination of scientific information led to fewer infections, so too may routine IOC decrease the incidence of BDIs and the problems arising from such injuries.

The data are there. It’s now up to the leaders of surgery and master surgical educators to embark on a plan to weave that data into the fabric of surgical practice. Until a future technology can reliably and objectively delineate the biliary tree intraoperatively, the scientific argument for routine IOC will remain persuasive.

When every reasonable physician in the same or similar circumstance performs routine IOC, the goal of IOC activism will have been achieved.

References

1. Berci G, et al. Am J Surg. 1991;161(13):355-360.
2. Carroll B, et al. Surg Endosc. 1996;10(3):319-323.
3. Flum D, et al. JAMA. 2003;289(13):1639-1644.
4. Waage A, et al. Arch Surg. 2006;141(12):1207-1231.
5. Roberts I, et al. J Gastroenterol Hepatol. 2009;24(5):762-769.
6. Buddingh KT, et al. J Am Coll Surg. 2011;213(2):267-271.
7. Alvarez FA, et al. Br J Surg. 2014;101(6):677-684.
8. Brunt LM, et al. Surg Endosc. 2020;34(7):2827-2855.

Dr. Gordon is a member of the editorial advisory board of General Surgery News.

Dr. Voeller’s Response to Dr. Gordon

Dr. Gordon is a well-respected and wonderful surgeon and writer, but he seems very frustrated by, and cannot understand, why only 20% of surgeons employ IOC routinely. It seems to me with these numbers, that selective IOC is the standard of care today in the United States, and that angers him. He apparently did not read the safe cholecystectomy guidelines on IOC wherein the “experts” trying to force these “guidelines” down our throats admit the evidence that IOC prevents BDI had a very low level of certainty. He even admits that at this point, “one still cannot say with clear and convincing scientific justification that performing IOC should be a requirement of the surgical standard of care.” Thank God for that.

Dr. Gordon suffers from the same arrogance and rigidity that the BDI consensus conference exhibits by saying he knows better, and since the majority of surgeons are not routinely doing IOC, we must force you to do so because we experts know best. If Dr. Gordon gets his way, the “authorities” will be coming at you from every direction to force you to do something that has a very low level of evidence that it will prevent major BDIs—regardless of when he says several times that the scientific evidence “proves” the benefits of IOC.

All surgeons want to do the best operations for their patients. IOC is an important tool. I think it is important to realize that major BDI occurs in only 0.3% to 0.5% for all laparoscopic cholecystectomies. I think it is a credit to all practicing surgeons that the incidence is so tremendously low. As someone who has done around 5,000 lap choles in the past 30 years with no BDIs and is a selective cholangiographer, what Dr. Gordon wants to force on me with his five-step manifesto will be of little benefit to my patients, and many practicing surgeons with similar results feel the same way.

Dr. Gordon’s Response to Dr. Voeller

Unfortunately for the patients of the world, there are not a million Professor Voellers to be teleported into ORs. Anyone who can pound out an essay about “guidelines” after a day full of three tough laparoscopic cholecystectomies on the heels of 5,000 cases without a BDI has to be heard.

The truth is that most surgeons, such as this writer, are well-qualified work-a-day surgeons who comprise the bulk of the bell curve of surgical expertise. I yield to Dr. Voeller’s surgical expertise; I do not yield to his opinion.

The largest cohort of surgeons—those of us who dwell in the middle of that bell curve—should attempt visualization of the extrahepatic biliary tree to guide dissection and to assure themselves that nothing has been injured during a laparoscopic cholecystectomy.

Although not “standard of care,” routine IOC should be attempted during every laparoscopic cholecystectomy. Refining the techniques of catheterizing the cystic duct, securing the catheter in place, stabilizing the operative field, intraoperative discussions and observations of the common duct, emptying mechanisms, and contour of the biliary tree all contribute to increasing surgical expertise, particularly when surgical residents are involved. A memorialized picture of the biliary tree confirms the safety of the dissection up to that point in the operation.

Even in the smallest hospitals, the catheters are available. There is a C-arm used in the orthopedic room. X-ray technicians may be summoned. We should use these tools. The skills acquired while performing IOC are adaptable to other areas of surgery—open, laparoscopic and robotic. For most of us without the surgical skills of Dr. Voeller, the “suboptimal” operation of subtotal cholecystectomy has been a useful alternative. Most people would rather have a retained portion of a gallbladder potentially necessitating a second operation than a BDI necessitating a Roux-en-Y hepaticojejunostomy at the university with a lifelong risk for stricture.

I agree sincerely with Dr. Voeller’s views on guidelines. Guidelines are organizational flavors of the month. I read the consensus conference report on BDI to which he refers. I did not find this summary to be rigid, oversimplified, inflexible or arrogant as Dr. Voeller states. The document is a general summary of the issue—a sincere, hard-working attempt to solve an ongoing surgical problem.

I also agree with his disdain for the term “never event.” It’s the old saw: “Never say never.” Unfortunately, that term is ingrained in the patient safety lexicon and will never go away.

Most of us will never achieve Dr. Voeller’s level of expertise, so we must rely on adjuncts such as IOC to get us through to safely ply our craft and avoid BDIs.

Send comments about this debate or ideas for future debate topic to khorty@mcmahonmed.com.