Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT07253389

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

Led by Air Force Military Medical University, China · Updated on 2025-11-28

170

Participants Needed

1

Research Sites

127 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-75 years
  • Diagnosis of liver cirrhosis based on clinical and imaging findings or histology if needed
  • High-risk acute variceal bleeding defined by Child-Pugh class C, or class B with active bleeding, or early rebleeding, or failure of pharmacologic and endoscopic therapy
  • History of esophagogastric variceal bleeding with failure of standard first-line therapy (endoscopic plus beta-blocker)
  • Scheduled to undergo TIPS procedure
  • Hepatic and renal function with Child-Pugh score 13; AST and ALT less than 5 times upper limit of normal; serum creatinine less than 1.5 times upper limit of normal
  • Ability and willingness to give written informed consent
Not Eligible

You will not qualify if you...

  • Budd-Chiari syndrome or non-cirrhotic portal hypertension
  • Current or prior cancer including liver or other malignancies
  • Complete thrombosis of the main portal vein
  • Severe psychiatric or neurological disorders like uncontrolled epilepsy or dementia
  • History of liver surgery or liver transplant
  • Previous TIPS or surgical portosystemic shunt
  • Pregnancy or lactation
  • Contraindications to TIPS including severe heart dysfunction, pulmonary hypertension, severe heart valve disease, or uncontrolled infection
  • Acute variceal hemorrhage with MELD score 30 or higher or arterial lactate over 12 mmol/L or acute-on-chronic liver failure
  • Severe or refractory overt hepatic encephalopathy without correctable shunt
  • Need for ongoing systemic treatment with glucocorticoids or NSAIDs

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Fourth Military Medical University

Xi'an, Shaanxi, China, 710032

Actively Recruiting

Loading map...

Research Team

J

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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here