Objective Limited data are available on the prevention of variceal rebleeding in cirrhotic patients with portal vein thrombosis (PVT). This study aimed to compare transjugular intrahepatic portosystemic shunt (TIPS) with covered stents versus endoscopic band ligation (EBL) plus propranolol for the prevention of variceal rebleeding among patients with cirrhosis and PVT. Design Consecutive cirrhotic patients (94% Child-Pugh class A or B) with PVT who had variceal bleeding in the past 6 weeks were randomly assigned to TIPS group (n=24) or EBL plus propranolol group (EBL+drug, n=25), respectively. Primary endpoint was variceal rebleeding. Secondary endpoints included survival, overt hepatic encephalopathy (OHE), portal vein recanalisation and rethrombosis, other complications of portal hypertension and adverse events. Results During a median follow-up of 30 months in both groups, variceal rebleeding was significantly less frequent in the TIPS group (15% vs 45% at 1 year and 25% vs 50% at 2 years, respectively; HR=0.28, 95% CI 0.10 to 0.76, p=0.008), with a significantly higher portal vein recanalisation rate (95% vs 70%; p=0.03) and a relatively lower rethrombosis rate (5% vs 33%; p=0.06) compared with the EBL+drug group. There were no statistically significant differences in survival (67% vs 84%; p=0.152), OHE (25% vs 16%; p=0.440), other complications of portal hypertension and adverse events between groups. Conclusion Covered TIPS placement in patients with PVT and moderately decompensated cirrhosis was more effective than EBL combined with propranolol for the prevention of rebleeding, with a higher probability of PVT resolution without increasing the risk of OHE and adverse effects, but this benefit did not translate into improved survival. Trial registration number ClinicalTrials.gov: NCT01326949.

中文翻译：

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覆盖 TIPS 与内镜套扎加普萘洛尔预防肝硬化门静脉血栓形成患者的静脉曲张再出血：一项随机对照试验

目的 预防肝硬化门静脉血栓形成 (PVT) 患者静脉曲张再出血的可用数据有限。本研究旨在比较经颈静脉肝内门体分流术 (TIPS) 与覆膜支架与内窥镜束带结扎术 (EBL) 加普萘洛尔预防肝硬化和 PVT 患者静脉曲张再出血的效果。设计 在过去 6 周内有静脉曲张出血的连续肝硬化患者（94% Child-Pugh A 或 B）被随机分配到 TIPS 组（n=24）或 EBL 加普萘洛尔组（EBL+药物，n=25 ）， 分别。主要终点是静脉曲张再出血。次要终点包括存活率、明显肝性脑病 (OHE)、门静脉再通和血栓形成、门静脉高压的其他并发症和不良事件。结果 在两组中位随访 30 个月期间，TIPS 组的静脉曲张再出血发生率显着降低（1 年分别为 15% 对 45% 和 2 年分别为 25% 对 50%；HR=0.28, 95 % CI 0.10 至 0.76，p=0.008），与对照组相比，门静脉再通率显着更高（95% 对 70%；p=0.03）和相对较低的再血栓形成率（5% 对 33%；p=0.06） EBL+药物组。组间生存率（67% 对 84%；p=0.152）、OHE（25% 对 16%；p=0.440）、门静脉高压的其他并发症和不良事件没有统计学上的显着差异。结论 PVT合并中度失代偿期肝硬化患者行覆盖TIPS预防再出血较EBL联合普萘洛尔更有效，PVT 解决的可能性更高，而不会增加 OHE 和不良反应的风险，但这种益处并没有转化为生存率的提高。试验注册号 ClinicalTrials.gov：NCT01326949。