Comparison of Underdilated Versus Standard TIPS in Preventing Variceal Rebleeding in Patients With Cirrhosis

Transjugular intrahepatic portosystemic shunt (TIPS) is a key therapeutic intervention for complications of portal hypertension. However, the risk of post-procedural hepatic encephalopathy (HE) limits its broader clinical application. In the management of gastroesophageal variceal bleeding, the primary goal of TIPS is to reduce the portosystemic pressure gradient (PPG) to less than 12 mmHg (16 cmH₂O), which defines the standard TIPS procedure. The investigators hypothesize that, in patients undergoing TIPS for the prevention of variceal rebleeding, stent underdilation using a 6-mm balloon (underdilated TIPS) will not increase the risk of rebleeding but may reduce the incidence of overt HE and attenuate liver injury. To test this hypothesis, the investigators have designed a prospective, multicenter, randomized controlled trial.

NCT Number	NCT07253389
Lead Sponsor	Air Force Military Medical University, China Collaborators: West China Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Daping Hospital of Army Medical University, General Hospital of Ningxia Medical University
Conditions	Liver Cirrhosis, Gastroesophageal Varices Bleeding
Enrollment	648 participants
Start Date	2025-10-20
Primary Completion	2029-09-30 (estimated)
Study Completion	2029-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-09