Department of Interventional Radiology, Zhongshan Hospital, Fudan University, Shanghai, China.
Shanghai Institution of Medical Imaging, Shanghai, China.
Trials. 2023 May 6;24(1):312. doi: 10.1186/s13063-023-07326-9.
Gastroesophageal varices (GOV) bleeding is a common and serious complication of advanced liver cirrhosis with a median survival of less than 2 years. Multiple guidelines have pointed out that transjugular intrahepatic portosystemic shunt (TIPS) is the rescue treatment of acute variceal hemorrhage (AVB) after failure of standard therapy and an effective second-line treatment for preventing patients with high risks from rebleeding of GOV. The safety and stability of TIPS have been greatly improved due to the improvements of related technologies and the emergence of various novel devices, but the incidence of hepatic encephalopathy (HE) after shunting (10-50%) hindered the widespread use of TIPS. The target portal vein branch might affect the incidence of HE after TIPS. The aim of this study is to compare the rate of HE in patients with hepatitis B virus (HBV) related cirrhosis receiving TIPS either the left or right branch of the portal vein with 8mm Viatorr stent for preventing rebleeding from GOV.
This study is a multicenter randomized controlled trial comparing the influence of shunting left or right portal vein branch on post-TIPS hepatic encephalopathy for preventing rebleeding from GOV in patients with HBV-related cirrhosis. A total of 130 patients will be recruited over a period of 24 months across 5 centers in China. Eligible patients will be stratified 1:1 to constructing either a left or right portal vein shunt with an 8-mm Viatorr stent. The primary objective was to compare the incidence of post-TIPS hepatic encephalopathy between the two groups. The secondary objectives were to compare the grade and duration of hepatic encephalopathy, the rate of shunt dysfunction, the rate of variceal rebleeding, the HE-free survival, the cumulative patency rate of the stent, and the overall survival at 12 months and 24 months between two groups.
This study was approved by the ethics committee of Zhongshan Hospital of Fudan University (No. B2018-292R) and was registered at ClinicalTrials.gov (NCT03825848). All participants give written informed consent.
ClinicalTrials.gov NCT03825848. Registered on January 31, 2019 TRIAL STATUS: The first patient was recruited into our study on June 19, 2019. A total of 55 patients were recruited till May 27, 2021 (27 and 28 patients assigned to shunting the left (L Group) and right (R Group) branches of the portal vein, respectively).
胃食管静脉曲张 (GOV) 出血是肝硬化晚期的常见且严重的并发症，中位生存期不足 2 年。多项指南指出，经颈静脉肝内门体分流术 (TIPS) 是标准治疗失败后急性静脉曲张出血 (AVB) 的抢救治疗方法，也是预防高危患者 GOV 再出血的有效二线治疗方法。由于相关技术的改进和各种新型装置的出现，TIPS 的安全性和稳定性得到了极大的提高，但分流术后肝性脑病 (HE) 的发生率 (10-50%) 阻碍了 TIPS 的广泛应用。目标门静脉分支可能会影响 TIPS 后 HE 的发生率。本研究旨在比较乙型肝炎病毒 (HBV) 相关肝硬化患者使用 8mm Viatorr 支架行 TIPS 治疗时，门静脉左支或右支分流对预防 GOV 再出血的影响。
这是一项多中心随机对照试验，比较了分流左或右门静脉分支对 TIPS 后预防 HBV 相关肝硬化患者 GOV 再出血的肝性脑病的影响。将在 24 个月内在中国的 5 个中心共招募 130 名患者。将符合条件的患者按 1:1 分层，分别用 8mm Viatorr 支架建立左或右门静脉分流。主要目的是比较两组 TIPS 后肝性脑病的发生率。次要目标是比较两组 HE 的严重程度和持续时间、分流功能障碍发生率、静脉曲张再出血率、HE 无生存时间、支架通畅率累积率和 12 个月和 24 个月的总生存率。
本研究得到了复旦大学中山医院伦理委员会的批准（编号：B2018-292R），并在 ClinicalTrials.gov 注册（NCT03825848）。所有参与者均签署了书面知情同意书。
ClinicalTrials.gov NCT03825848。注册于 2019 年 1 月 31 日
第一位患者于 2019 年 6 月 19 日入组本研究。截至 2021 年 5 月 27 日，共招募了 55 名患者（分别为 27 名和 28 名患者被分配至门静脉左支（L 组）和右支（R 组）分流）。
