Safe Cholecystectomy Multi-Society Practice Guideline and State of the Art Consensus Conference on Prevention of Bile Duct Injury During Cholecystectomy

L. Michael Brunt, MD; Daniel J. Deziel, MD; Dana A. Telem, MD, MPH; Steven M. Strasberg, MD; Rajesh Aggarwal, MD; Horacio Asbun, MD; Jaap Bonjer, MD; Marian McDonald, MD; Adnan Alseidi, MD; Mike Ujiki, MD; Taylor S. Riall, MD, PhD; Chet Hammill, MD; Carol-Anne Moulton, MD; Philip H. Pucher, MD; Rowan W. Parks, MD; Mohammed T. Ansari, MD, MMedSc, MPhil; Saxon Connor, MD; Rebecca C. Dirks, MD; Blaire Anderson, MD; Maria S. Altieri, MD; Levan Tsamalaidze, MD; Dimitrios Stefanidis, MD, PhD

Disclosures

Annals of Surgery. 2020;272(1):3-23. 

In This Article

Discussion

BDI is the most common severe complication of cholecystectomy. It is very morbid, greatly increases the cost of care, and often leads to litigation. For a procedure that is normally outpatient, with the expectation of an almost immediate return to normal activity, the consequences can be devastating. Since the 1992 NIH sponsored consensus conference on LC,[177] there has been no consensus-type meeting focused on the safety of this operation despite substantial evolution of the field. This 2018 conference brought together experts from several surgical organizations with different principal areas of expertise to develop evidence-based recommendations in collaboration with the SAGES Guidelines Committee.

In the initial consensus voting process, only 3 recommendations did not meet the 80% threshold for approval by the 25 voting experts (Questions 3, 9, and 13). Questions 9 and 13 were revised based on the meeting discussion and feedback and were re-voted on electronically by the expert panel and approved (96.2% and 88.5% agreement, respectively). Audience voting participation at the meeting was concordant for approval with expert voting with discrepancies on Question 4 (88.5% expert panel vs 77.3% audience) and Question 6 Recommendation A1 (85% expert panel vs 77.3% audience).

Dissemination of BDI Guidelines

The dissemination of these guidelines broadly throughout the surgical community will require engagement of diverse stakeholders. Guideline recommendations will be promoted on society websites (such as the sages.org/safe-cholecystectomy-program) and through panel sessions at meetings of surgical societies. To reach an international audience, translation of the guideline document into other languages will be investigated. Engaging surgeons through social media such as specialty Facebook groups (eg, SAGES Masters Biliary Facebook group) and networks of online communities which engage community surgeons are needed. The guidelines should also be distributed to hospitals, healthcare systems, healthcare plans, malpractice insurers, and to patient safety organizations. Finally, dissemination into general surgery training programs in the US and worldwide will be critical to impacting the next generation of practicing surgeons.

Implementation of Guidelines and Adoption

Guideline implementation will be undertaken by an implementation team consisting of members of the GDG and stakeholder societies that will meet periodically until the next guideline update. The team will continually evaluate barriers and facilitators (eg, through stakeholder surveys) of guideline adoption. The team will include members of the SAGES Safe Cholecystectomy Task Force and Guidelines Committee along with representatives from the other consensus conference society members. The team will also ensure professional development opportunities and coaching and monitor the effectiveness of guideline implementation using pre-specified outcome measures. This approach will help ensure that relevant changes are made to the existing implementation plan as needed.

Limitations

The quality of evidence of many studies was low with resultant moderate to high risk of bias for many key questions. This resulted in many conditional or expert opinion based recommendations. For some questions, few relevant studies were available which precluded formulation of a recommendation. Randomized trials in which BDI is an outcome are not feasible because of the low frequency of BDI that would necessitate enrollment of a very large number of patients (>5000) per arm. Proxy outcomes for BDI may be used in some cases such as identification of anatomy, but the degree of correlation with the primary outcome of BDI is unknown. A final limitation is that direct involvement of patients with BDI and their families was not included in the consensus meeting, although every effort was made to consider that perspective in the GDG deliberation process.

Future Research Recommendations

An important aspect of these guidelines is the provision of recommendations for future research studies. Areas for future investigation include the role of new imaging modalities in high risk populations, risk stratification for surgery and timing of cholecystectomy, education and training strategies to reduce biliary injury, and development of national or society related registries. The low incidence of BDI at any one institution and the absence of national registries for tracking BDI makes the study of this problem and efforts to impact it challenging. Current observational studies are underpowered with limited generalizability, as most originate from single institutions and/or report sample sizes too small to adequately detect BDI. Studies with adequate sample size are often derived from claims or administrative data that are at high risk of bias and lack the clinical nuance necessary to identify key patient and operative elements critical to the prevention of BDI. Therefore, the development of national quality improvement initiatives for the identification and tracking of BDIs after cholecystectomy should be one of the most important steps taken going forward.

Updating BDI Guidelines

These guidelines will be reviewed and updated within 5 years of publication. In addition, the literature on BDI and cholecystectomy will be monitored annually for new publications that pertain to the key questions and recommendations from this guideline. It is also anticipated that the recommendations for future research, based on evidence and knowledge gaps identified in this review, will lead to the formation of well designed, prospective studies that will enhance understanding of areas of controversy in the field.

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