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

Study acronym: UVR-TIPS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment target: 170 to 648v2 Show 5 more changesShow less
    • Primary and study completion dates: Mar 31, 2028 to Sep 30, 2029
    • Start date: Oct 21, 2025 to Oct 20, 2025
    • Eligibility criteria expanded, about 40 words
    • Secondary endpoints: details revised at 1 of 6 entries
    • Collaborators expanded, about 26 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)		 Liver Cirrhosis, Gastroesophageal Varices Bleeding
Related terms Hepatic Encephalopathy, Liver Cirrhosis
Enrollment 648 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov