Comparison of underdilated versus standard transjugular intrahepatic portosystemic shunt in preventing rebleeding from oesophagogastric varices in patients with cirrhosis in Chinese tertiary hospitals: protocol for a multicentre randomised controlled
Lei Liu, Bo Wei, Feng Zhang, Wen Liang-Zhi, Wentun Yao, Xulong Yuan, Xiaoyuan Gou, Kai Li, Zhen Wang, Ying Zhu, Jiao Xu, Jing Niu, Na Han, Rui Gao, Yuzheng Zhuge, Hao Wu, Jun TieIntroduction
Hepatic encephalopathy (HE) is a major complication following transjugular intrahepatic portosystemic shunt (TIPS) placement, significantly affecting patients’ quality of life and long-term prognosis. This study aims to compare the efficacy of underdilated TIPS versus standard TIPS in preventing variceal rebleeding in patients with cirrhosis and portal hypertension and to evaluate the incidence of post-procedural HE.
Methods and analysis
This multicentre randomised controlled trial will be conducted across five Grade A tertiary hospitals in China. A total of 648 patients with portal hypertension-related oesophagogastric variceal bleeding undergoing TIPS will be enrolled and randomly assigned in a 1:1 ratio to either the experimental or control group. In the experimental group, underdilated TIPS will be performed using 6 mm balloon for stent expansion. In the control group, standard TIPS will be performed using progressive balloon dilation, starting at 8 mm and increasing stepwise as needed until the portosystemic pressure gradient is reduced to <12 mm Hg. The primary endpoint is the rebleeding rate over the entire follow-up period after TIPS. Secondary endpoints include the incidence of HE and liver function impairment. All statistical analyses will be performed using SPSS V.27.0 (IBM, Armonk, New York, USA), with a significance level set at p<0.05.
Ethics and dissemination
The study protocol (V.2, 1 July 2025) has been approved by the Medical Ethics Committee of the First Affiliated Hospital of Air Force Medical University (Approval No.: KY20252233-F-2). Written informed consent will be obtained from all participants prior to enrolment. Findings will be presented at academic conferences and published in peer-reviewed journals.
Trial registration number
ChiCTR2500110490;