Bile Duct Injury Prevention Requires a New National Training Paradigm Despite Successful Deployment of FLS

Steven D Schwaitzberg, MD, Daniel J Scott, MD, Daniel B Jones, MD, Sophia K McKinley, BA, EdM, Johanna Castrillion, MD, Tina Hunter, PhD, L. Michael Brunt, MD. Harvard Medical School, UT Southwestern School of Medicine, S2 Statistical Solutions, Washington University School of Medicine.

Bile duct injury (BDI) remains the dreaded complication of laparoscopic cholecystectomy (LC) with minimal improvement over the last 2 decades. Although Fundamentals of Laparoscopic Surgery (FLS) certification is now required for new applicants by the American Board of Surgery, the impact of FLS on procedure specific outcomes is unknown. Moreover, the FLS content centers on fundamental education and not procedure specific complication reduction such as BDI, magnifying the importance of understanding the educational impact of FLS on specific case types. This study reviewed the impact of FLS certification and other factors on the incidence of bile duct injury in a large insurance claims database.
Methods: 53,632 LCs were reviewed from Q32009 to Q42010 from a large private payor claims database. Surgeon National Provider Identification (NPI), FLS certification status, ICD-9 and CPT were available for each event. Each record was analyzed for evidence of any major bile duct injury based on associated CPT or ICD-9 data in the claim record. Characteristics of the FLS+ and FLS– surgeon groups were analyzed by a separate reviewer blinded to clinical outcome on a large scale.
Results:1694 LC were performed by FLS+ and 51,938 by FLS- surgeons. 82 BDI were identified: 8 in the FLS+ and 72 in the FLS– group. The FLS+ group had a higher rate of BDI than the FLS– group (.47% vs .14%, p=.0013); however, the FLS+ group was also younger (mean age 38.2 FLS+ vs 50.4 yrs FLS -) had significantly fewer years in practice ( FLS+ = 6.1 vs FLS- =20.7 p=.0012). No other complications showed differences between the groups.
Conclusion:  Nationally mandated training programs such as FLS  allows for the study of the comparative effectiveness of training on clinical outcome. Although the scientific validity of FLS is well established, there is no content in the program relative to BDI prevention. Our results do suggest that FLS certification seems to offset lack of surgeon experience for general complications of LC, but not for bile duct injury.  Large scale and validated training and assessment programs targeted at BDI prevention are needed if we are to attempt to shorten the pathway to higher levels of proficiency for surgeons performing laparoscopic cholecystectomy.