Underdilated versus standard TIPS to prevent variceal rebleeding in cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized controlled trial comparing underdilated TIPS (stent underexpanded using a 6-mm balloon) with standard TIPS in patients with cirrhosis at high risk for gastroesophageal variceal rebleeding. Eligible participants will be randomized to one of the two stent-dilation strategies and undergo standardized TIPS placement with hemodynamic targets and scheduled follow-up. The trial's primary outcomes include variceal rebleeding and incidence of overt hepatic encephalopathy, with secondary endpoints assessing liver function, shunt patency, and procedure-related complications. The goal is to see if a smaller effective stent diameter can maintain bleeding control while reducing the risk of post‑TIPS HE and attenuating liver injury.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1\. Age 18-75 years. 2. Diagnosis of liver cirrhosis according to the 2023 Consensus Opinion on the Clinical Diagnosis and Treatment of Liver Cirrhosis in China (Chinese Society of Gastroenterology). Diagnosis is based on clinical manifestations and imaging findings; histological confirmation is required if the diagnosis remains inconclusive.

3\. High-risk acute variceal bleeding, defined as any of the following:

1. High-risk acute esophageal or type 1 gastroesophageal variceal bleeding, including: Child-Pugh grade B with a score \> 7 and endoscopic evidence of active bleeding; Child-Pugh grade C with a score \< 14.
2. Hepatic venous pressure gradient (HVPG) \> 20 mmHg during bleeding.
3. Early rebleeding within 5 days.
4. Bleeding uncontrolled despite pharmacological and endoscopic therapy. 4. History of esophageal or gastric variceal bleeding with failure of standard first-line treatment \[endoscopy combined with non-selective beta-blockers (NSBB)\]; or first hemorrhage accompanied by grade 2 ascites and/or portal vein thrombosis; GOV2 or IGV1 gastric variceal bleeding; ectopic variceal bleeding; or bleeding from refractory portal hypertensive gastropathy.

5\. Planned TIPS procedure. 6. Ability and willingness to provide written informed consent.

Exclusion Criteria:

1. Budd-Chiari syndrome or other causes of non-cirrhotic portal hypertension.
2. Current or prior malignancy, including hepatocellular carcinoma or malignancies of other organs.
3. Complete thrombosis of the main portal vein.
4. Severe psychiatric or neurologic disorders (e.g., uncontrolled epilepsy, dementia).
5. Prior liver resection or liver transplantation.
6. Prior TIPS or surgical portosystemic shunt.
7. Pregnancy or lactation.
8. Any contraindication to TIPS, including:

(1) Congestive heart failure (New York Heart Association class C or D, or left ventricular ejection fraction \< 50%).

(2) Severe pulmonary hypertension (mean pulmonary artery pressure \> 45 mmHg as measured invasively).

(3) Uncontrolled systemic infection. (4) Severe overt hepatic encephalopathy (OHE) with unmodifiable spontaneous portosystemic shunt.

9.Acute hemorrhage with a MELD score ≥ 30 and/or arterial lactate \> 12 mmol/L, or presence of acute-on-chronic liver failure (ACLF).

10\. Systemic conditions requiring ongoing glucocorticoid or nonsteroidal anti-inflammatory drug (NSAID) therapy.

Where it's running

• Fourth Military Medical University
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Principal investigator: Jun Tie — Air Force Military Medical University, China
• Study coordinator: Jun Tie, M.D.,Ph.D.
• Email: tiejun7776@163.com
• Phone: +862984771537

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.