Zhang Wei, Zhang Ming, Xiao Jiangqiang, Li Ruiqi, Chen Yiran, Zhang Xiaofeng, Yu Zhiyuan, Yin Qin, Li Taishun, Wang Lei, Zhuge Yuzheng, Zhang Feng
Department of Gastroenterology, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
Medical Statistical Analysis Center, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
Clin Gastroenterol Hepatol. 2025 Jul 7. doi: 10.1016/j.cgh.2025.06.023.
Transjugular intrahepatic portosystemic shunt (TIPS) is associated with an increased incidence of hepatic encephalopathy (HE). We aimed to compare the clinical effectiveness of 6-mm and 8-mm TIPS for secondary prophylaxis of variceal bleeding in patients with cirrhosis who were at risk for HE.
This was an investigator-initiated, open-label, single-center, parallel, randomized controlled trial. Patients with cirrhosis and variceal bleeding were randomly assigned to the 6- or 8-mm covered TIPS groups. The primary endpoint was all-cause rebleeding after 2 years.
Between September 20, 2017 and September 17, 2021, 144 patients were enrolled and randomly assigned to either the 6-mm (n = 72) or 8-mm (n = 72) TIPS group. Overall, 24 (33.3%) and 16 (22.2%) patients in the 6-mm and 8-mm groups, respectively, experienced rebleeding. In the 6-mm and 8-mm groups, the cumulative rates of rebleeding were 35.2% and 24.1%, respectively (P = .187). The 2-year cumulative incidence of overt HE was significantly higher in the 8-mm group than in the 6-mm group (42.0% vs 20.3%; P = .009). The 2-year actuarial survival rates were 84.6% in the 6-mm group and 83.0% in the 8-mm group.
Among this cohort of patients with cirrhosis who are receiving TIPS for the secondary prevention of variceal bleeding, the use of 6-mm stents results in a higher rate of rebleeding but has similar survival and a significantly lower risk of overt HE compared with 8-mm stents. Chinese Clinical Trial Registry, No. ChiCTR-INR-17012479.
经颈静脉肝内门体分流术（TIPS）与肝性脑病（HE）发病率增加相关。我们旨在比较6毫米和8毫米TIPS对有HE风险的肝硬化患者预防静脉曲张出血的临床效果。
这是一项由研究者发起的、开放标签、单中心、平行、随机对照试验。肝硬化合并静脉曲张出血的患者被随机分配至6毫米或8毫米覆膜TIPS组。主要终点为2年后全因再出血。
2017年9月20日至2021年9月17日，144例患者入组并随机分配至6毫米（n = 72）或8毫米（n = 72）TIPS组。总体而言，6毫米组和8毫米组分别有24例（33.3%）和16例（22.2%）患者发生再出血。6毫米组和8毫米组的再出血累积率分别为35.2%和24.1%（P = 0.187）。8毫米组显性HE的2年累积发病率显著高于6毫米组（42.0%对20.3%；P = 0.009）。6毫米组和8毫米组的2年精算生存率分别为84.6%和83.0%。
在这群接受TIPS预防静脉曲张出血的肝硬化患者中，与8毫米支架相比，使用6毫米支架导致再出血率更高，但生存率相似，显性HE风险显著更低。中国临床试验注册中心，注册号：ChiCTR-INR-17012479。
