RecruitingNot Applicable

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

China170 participantsStarted 2025-10-21

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age 18-75 years;
✓. Diagnosis of liver cirrhosis based on clinical and imaging findings according to the 2023 Consensus Opinion on the Clinical Diagnosis and Treatment of Liver Cirrhosis in China (Chinese Society of Gastroenterology); histological confirmation required if diagnosis is inconclusive;
✓. High-risk acute variceal bleeding, defined as presence of any of the following: Child-Pugh class C; Child-Pugh class B with active endoscopic evidence of bleeding; early rebleeding within 5 days; or failure of pharmacologic and endoscopic therapy to control bleeding;
✓. History of esophagogastric variceal bleeding with documented failure of standard first-line therapy (endoscopic intervention plus nonselective beta-blocker, NSBB);
✓. Scheduled to undergo TIPS;
✓. Hepatic and renal function meeting all of the following criteria: Child-Pugh score ≤13; AST and ALT \<5× upper limit of normal (ULN); serum creatinine \<1.5× ULN;
✓. Ability and willingness to provide written informed consent.

What they're measuring

Cumulative incidence of gastroesophageal variceal rebleeding.

Timeframe: Throughout the entire follow-up period（up to 12 months）

Trial details

NCT IDNCT07253389

SponsorAir Force Military Medical University, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-31

Contact for this trial

Jun Tie, M.D.,Ph.D.

+862984771537 tiejun7776@163.com

View on ClinicalTrials.gov More Liver Cirrhosis trials