RESUMEN
OBJECTIVE: To compare the incidence and severity of biliary complications due to liver transplantation after choledochocholedochostomy with or without a T-tube in a single-center, prospective, randomized trial. SUMMARY BACKGROUND DATA: The usefulness of the T-tube for end-to-end biliary anastomosis to reduce the incidence of biliary complications in patients undergoing liver transplantation has been controversial. METHODS: A per-protocol analysis was designed for liver recipients, who were randomly assigned to choledochocholedochostomy with (n = 95) or without (n = 92) a T-tube. RESULTS: The overall biliary complication rate was 22.5% (n = 42), with no difference between groups (P = 0.35). The majority (66.7%) of complications in the T-tube group were types I and II, whereas 50% were type IIIa and 44% were type IIIb in the non-T-tube group (P < 0.0001). Fewer anastomotic strictures were found in the T-tube group (n = 2, 2.1%) than in the non-T-tube group (n = 13, 14.1%; P = 0.002). No difference in anastomotic biliary leakage was observed between groups. Biliary complication-free survival rates showed that complications appeared earlier in the T-tube group. Graft and patient survival rates were similar in both groups. CONCLUSIONS: Complications in the T-tube group were less severe and required less aggressive treatment. The incidence of anastomotic strictures was higher in patients with no T-tube. We recommend conducting choledochocholedochostomy with a rubber T-tube during liver transplantation in risky anastomosis and when the bile duct diameter is less than 7 mm. This study is registered at http://www.clinicaltrials.gov: Clinical trial ID# NCT01546064.