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

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