静脉曲张栓塞在经颈静脉肝内门体分流术 (TIPS) 中用于预防胃食管静脉曲张再出血的作用仍存在争议。本研究旨在评估在 TIPS 放置中添加静脉曲张栓塞是否可以降低肝硬化患者 TIPS 后再出血的发生率。

我们在中国的一所大学医院进行了一项开放标签、随机对照试验。符合条件的患者年龄在 18-75 岁之间，患有肝硬化并在过去 6 周内发生过静脉曲张出血，他们被随机分配（1:1）接受 TIPS（两组均使用覆膜支架）加静脉曲张栓塞（TIPS 加栓塞组） ) 或单独使用 TIPS（TIPS 组）以防止静脉曲张再出血。随机化是使用基于网络的随机化系统完成的，该系统使用 Pocock 和 Simon 的最小化方法，按 Child-Pugh 类（A vs B vs C）分层。临床医生和患者不知道治疗分配；参与数据分析的个人被掩盖了治疗分配。主要终点是随机分组后 2 年的静脉曲张再出血累积发生率，分析是通过意向治疗进行的。

2014 年 6 月 16 日至 2016 年 2 月 3 日期间，筛选了 205 名患者，其中 134 名随机分配到 TIPS 加栓塞组（n=69）和 TIPS 组（n=65）。 TIPS 放置和静脉曲张栓塞在所有 134 名患者中均成功，所有患者均被纳入分析。两组间静脉曲张再出血的 2 年累积发生率无显着差异（TIPS 加栓塞 11·6% [95% CI 4·0-19·1] vs TIPS 13·8% [5·4- 22·2]；风险比 0·82 [95% CI 0·42-1·61]；p=0·566)。两组之间的不良事件相似；最常见的不良事件是消化性溃疡或胃炎（TIPS 加栓塞组患者为 12 [17%] 对 TIPS 组患者为 13 [20%]），新的或恶化的腹水（10 [14%] vs 6 [9%]）和肝细胞癌（4 [6%] 对 6 [9%]）。各组之间的死亡人数也相似（24 [35%] vs 25 [38%]） 解释：在 TIPS 中加入静脉曲张栓塞并没有显着降低肝硬化患者静脉曲张再出血的发生率。我们的研究结果不支持在 TIPS 期间同时进行静脉曲张栓塞以预防静脉曲张再出血。

Abstract

Background: The role of variceal embolisation at the time of transjugular intrahepatic portosystemic shunt (TIPS) creation for the prevention of gastro-oesophageal variceal rebleeding remains controversial. This study aimed to evaluate whether adding variceal embolisation to TIPS placement could reduce the incidence of rebleeding after TIPS in patients with cirrhosis.

Methods: We did an open-label, randomised controlled trial at one university hospital in China. Eligible patients were aged 18-75 years with cirrhosis and had variceal bleeding in the past 6 weeks, and they were randomly assigned (1:1) to receive TIPS (with a covered stent in both groups) plus variceal embolisation (TIPS plus embolisation group) or TIPS alone (TIPS group) to prevent variceal rebleeding. Randomisation was done using a web-based randomisation system using a Pocock and Simon's minimisation method, stratified by Child-Pugh class (A vs B vs C). Clinicians and patients were not masked to treatment allocation; individuals involved in data analysis were masked to treatment assignment. The primary endpoint was the 2-year cumulative incidence of variceal rebleeding after randomisation, and analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, NCT02119988.

Findings: Between June 16, 2014, and Feb 3, 2016, 205 patients were screened, of whom 134 were randomly allocated to the TIPS plus embolisation group (n=69) and the TIPS group (n=65). TIPS placement and variceal embolisation was successful in all 134 patients, all were included in the analysis. There was no significant difference in the 2-year cumulative incidence of variceal rebleeding between the two groups (TIPS plus embolisation 11·6% [95% CI 4·0-19·1] vs TIPS 13·8% [5·4-22·2]; hazard ratio 0·82 [95% CI 0·42-1·61]; p=0·566). Adverse events were similar between the two groups; the most common adverse events were peptic ulcer or gastritis (12 [17%] of patients in the TIPS plus embolisation group vs 13 [20%] of patients in the TIPS group), new or worsening ascites (ten [14%] vs six [9%]), and hepatocellular carcinoma (four [6%] vs six [9%]). The numbers of deaths were also similar between groups (24 [35%] vs 25 [38%]) INTERPRETATION: Adding variceal embolisation to TIPS did not significantly reduce the incidence of variceal rebleeding in patients with cirrhosis. Our findings do not support concomitant variceal embolisation during TIPS for the prevention of variceal rebleeding.

原文链接

https://pubmed.ncbi.nlm.nih.gov/35588750/

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