Multicenter Randomised Controlled Trial of Single versus Double Venous Outflow Reconstruction in Right lobe Living Donor Liver Transplantation- Venous Outflow in Liver Transplantation (VOLT) Trial.
Reddy, M. S., et al.Annals of Surgery 2024 [record in progress].
Aims
The authors aim to compare early patency of the reconstructed anterior sector vein (neoMHV) and clinical outcomes between a single outflow technique (SOT) and double outflow technique (DOT) in right lobe living donor liver transplantation (RtLDLT).
Interventions
One arm received the double outflow technique (DOT): Separate anastomoses of the right hepatic vein (RHV) and the prosthetic neo-middle hepatic vein (neoMHV) to the recipient inferior vena cava (two openings). The other arm received the single outflow technique (SOT): Conjoint venoplasty on the back table, creating a single common outflow orifice (RHV + neoMHV together) that is then anastomosed en bloc to the recipient vena cava (one opening)
Participants
219 adult patients undergoing right lobe LDLT who required prosthetic anterior sector vein (ASV) reconstruction. To be included grafts needing at least one reconstructed ASV (>4 mm). Prosthetic grafts (PTFE or Dacron) used. Key exclusion criteria were: retransplant, graft with middle hepatic vein included, non-prosthetic reconstructions, contraindication to contrast imaging.
Outcomes
The primary outcome was NeoMHV (anterior sector vein) patency at multiple time points (2, 4, and 6 weeks post-transplant) evaluated by Doppler ultrasound and cross-sectional imaging. The secondary outcomes were: Intraoperative metrics (cold ischemia time, graft implantation time, blood loss, etc.), postoperative complications (e.g., vascular/biliary events, Clavien-Dindo classification, Comprehensive Complications Index), early allograft dysfunction, ICU/hospital length of stay & In-hospital, 90-day, and 1-year patient survival.
Follow-up
Primary patency assessments up to 6 weeks post-transplant. Additional postoperative outcomes (includ
CET Conclusions
The authors conducted a well-designed and blinded Multicentre, randomized controlled trial at 5 LDLT centres in India. 219 recipients were included in the study with 110 undergoing SOT and 109 DOT. They demonstrated NeoMHV Patency was significantly better at 2 weeks (92.5% vs. 82.9%, p=0.032) and 4 weeks (84% vs. 69%, p=0.011) in SOT compared to DOT, but at 6 weeks, the difference was not statistically significant (69.5% vs. 59.2%, p=0.124).Cox proportional hazards analysis identified DOT and Dacron graft use as independent predictors of early neoMHV thrombosis. With regards their clinical Outcomes SOT had slightly shorter graft implantation time (41 min vs. 49 min, p=0.002). In-hospital mortality was lower in SOT (2.7% vs. 9.2%, p=0.044), but no difference in 1-year survival. NeoMHV thrombosis before 4 weeks was associated with worse morbidity and early mortality, underscoring the importance of early outflow patency. Overall this is a good quality study on a very specialised procedure within LDLT, they constructed a multicentre RCT design with reasonably balanced groups. They recognise the potential limitations of potential centre-specific protocol variations and short-to-medium follow-up for patency. In right lobe LDLT requiring anterior sector venous reconstruction, single outflow technique in the correct hands appears to achieve better early venous patency and may confer a survival advantage during the initial postoperative period. Further long-term data are required to evaluate late outcomes.
Data analysis
Strict intention-to-treat analysis
Trial registration
CTRI Number - REF/2021/08/046152