右半肝活体肝移植中单支与双支静脉流出道重建的多中心随机对照试验：肝移植中的静脉流出道试验

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

作者信息

Reddy Mettu Srinivas, Koneti Akshadhar J, Chaudhary Abhideep, Rammohan Ashwin, Yalakanti Raghavendra Babu, Mallick Shweta, Patcha Rajanikanth, Singh Vipin Pal, Krishnan Satish Kumar, Kumar Niteen, Gopal Prasanna, Rela Mohamed, Sudhindran Surendran

机构信息

Department of Liver Transplantation and HPB Surgery, Gleneagles Health City, Chennai, TN, India.

Department of HPB Surgery and Liver Transplantation, Gleneagles Hospital, Hyderabad, TG, India.

出版信息

Ann Surg. 2025 Jun 1;281(6):911-920. doi: 10.1097/SLA.0000000000006601. Epub 2024 Dec 11.

DOI:10.1097/SLA.0000000000006601

PMID:39660425

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.

摘要

目的

在一项多中心开放标签随机对照试验中，比较右半肝活体供肝移植（RtLDLT）中单一流出道重建[单一流出道技术（SOT）]和双流出道重建[双流出道技术（DOT）]的早期通畅情况及预后。

背景

最佳的移植肝静脉流出道是决定RtLDLT预后的关键因素。目前尚无直接比较移植肝流出道重建的SOT和DOT技术的数据。

方法

纳入接受RtLDLT且需要重建肝中叶静脉的成年患者。使用人工血管构建新的肝中静脉（neoMHV）。在移植前，采用基于网络的排列分组随机化方法将患者按1:1随机分配至SOT或DOT组。主要终点是neoMHV长达6周的通畅情况。次要终点是术后发病率和生存率。报告意向性分析和实际治疗分析结果。

结果

5个中心将219例患者随机分为SOT组（n = 110）或DOT组（n = 109）。两组基线特征相似。SOT组在2周时neoMHV通畅率更高（92.5%对82.9%，P = 0.032），4周时也更高（84%对69%，P = 0.011），但6周时无差异（69.5%对59.2%，P = 0.124）。Cox比例风险分析显示，DOT[风险比：1.56（95%CI = 1.02, 2.4）；P = 0.041]和使用涤纶血管[风险比：2.83（95%CI = 1.16, 6.94），P = 0.023]是neoMHV血栓形成的独立危险因素。SOT组住院生存率更高（97.3%对90.8%；P = 0.044），但1年生存率相似（89%对85%，P = 0.340）。SOT与发生早期移植肝功能障碍或需要再次手术的患者生存率提高相关。