Multicenter Randomised Controlled Trial of Single Versus Double Venous Outflow Reconstruction in Right Lobe Living Donor Liver Transplantation: Venous Outflow in Liver Transplantation Trial.

Abstract

Objective: To compare early patency and outcomes of single outflow [single outflow technique (SOT)] and double outflow [double outflow technique (DOT)] reconstruction in right lobe living donor liver transplantation (RtLDLT) in a multicenter open-labeled randomized controlled trial.

Background: Optimum graft venous outflow is a key factor in determining outcomes of RtLDLT. There are no data directly comparing SOT and DOT techniques of graft outflow reconstruction.

Methods: Adult patients undergoing RtLDLT needing anterior sector vein reconstruction were enrolled. A prosthetic graft was used to create a neo-middle hepatic vein (neoMHV). Web-based permuted block randomization was used to allocate patients to SOT or DOT (1:1) before graft implantation. The primary endpoint was neoMHV patency for up to 6 weeks. Secondary endpoints were postoperative morbidity and survival. Intention-to-treat and as-treated analyses are reported.

Results: Five centers randomized 219 patients to SOT (n = 110) or DOT (n = 109). Both groups were similar in baseline characteristics. SOT had better neoMHV patency at 2 weeks (92.5% vs 82.9%, P = 0.032), 4 weeks (84% vs 69%, P = 0.011) but not at 6 weeks (69.5% vs 59.2%, P = 0.124). Cox proportional hazards analysis revealed DOT [hazard ratio: 1.56 (95% CI = 1.02, 2.4); P = 0.041] and use of Dacron graft [hazard ratio: 2.83 (95% CI = 1.16, 6.94), P = 0.023] as independent risk factors for neoMHV thrombosis. SOT was associated with better in-hospital survival (97.3% vs 90.8%; P = 0.044) but similar 1-year survival (89% vs 85%, P = 0.340). SOT was associated with improved survival in patients who developed early allograft dysfunction or needed reoperation.

Conclusions: SOT has better early neoMHV patency than DOT and may be associated with better early survival.