Recommendations of an International Multidisciplinary Committee on standards for reporting outcomes of treating biliary injuries

Background: A standard way of reporting outcomes of treatment of biliary injury is needed. The method should permit evaluation and comparison of surgical, endoscopic, and interventional radiologic treatments. A 19 person international multidisciplinary group has addressed this problem. Methods: The method is based on the concept of “Patency”, derived partly from reporting standards for arteriovenous hemodialysis access. Patency means an open functional biliary tree without devices, interventions, or episodes of infection, obstruction, or fistula. “Primary Patency” is achieved when patency exists at the end of the index treatment period, which is 3 months from surgical reconstruction and 12 months from initiation of treatment for non-surgical interventions. Primary patency is lost if subsequent interventions are needed or infection, obstruction or fistula occur. Attainment of patency after the index treatment period or restoration of patency after primary patency is lost is called “Secondary Patency”. Biliary injuries are graded according to severity (3 grades) and results according to patency (4 grades) The latter includes primary patency (Grade A), 2 levels of secondary patency (Grades B,C) and lack of patency (Grade D). The key metrics are Per Cent of Patients Attaining Primary Patency and the Actuarial Primary Patency Rate (APPR). Results: APPR is calculated like a Kaplan-Meier cancer survival curve with primary patency equivalent to survival (Figure). APPR has the advantages of having time as a continuous variable and the ability to account for variable follow-up periods. Conclusion: This method provides a rational approach to reporting outcomes of treatment of bile duct injuries in future studies.