Underdilated versus standard TIPS to prevent variceal rebleeding in cirrhosis

A Multicenter Randomized Controlled Trial: Comparison of Underdilated Versus Standard Transjugular Intrahepatic Portosystemic Shunt in Preventing Rebleeding From Esophagogastric Varices in Patients With Cirrhosis

We will test whether using a slightly smaller TIPS stent (underdilated with a 6-mm balloon) instead of a standard stent lowers repeat variceal bleeding and reduces hepatic encephalopathy in people with cirrhosis who need TIPS.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 170 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Air Force Military Medical University, China (Academic / other)
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT07253389 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with cirrhosis who have high‑risk gastroesophageal variceal bleeding, have failed or are unsuitable for first‑line therapy, and meet the trial's liver and kidney function criteria are the intended participants.

Not a fit: Patients with very advanced liver or renal failure beyond the trial's entry limits, those who are not TIPS candidates, or those without high‑risk variceal bleeding are unlikely to receive benefit from the intervention tested here.

Why it matters

Potential benefit: If successful, this approach could keep bleeding under control while lowering the rate of post‑TIPS hepatic encephalopathy and reducing liver injury.

How similar studies have performed: Previous smaller observational studies and limited trials of smaller‑diameter or underdilated TIPS have suggested reduced encephalopathy but have produced mixed results with limited long‑term data, so larger randomized evidence is still needed.

Eligibility criteria

Inclusion Criteria:

1. Age 18-75 years;
2. 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;
3. 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;
4. History of esophagogastric variceal bleeding with documented failure of standard first-line therapy (endoscopic intervention plus nonselective beta-blocker, NSBB);
5. Scheduled to undergo TIPS;
6. 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;
7. 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 extrahepatic malignancies; (3) complete thrombosis of the main portal vein; (4) severe psychiatric or neurological disorders (e.g., uncontrolled epilepsy, dementia); (5) history of liver resection or liver transplantation; (6) prior TIPS or surgical portosystemic shunt; (7) pregnancy or lactation; (8) any contraindication to TIPS, including severe right or left ventricular dysfunction, moderate-to-severe pulmonary hypertension despite optimal medical therapy, untreated severe valvular heart disease, or uncontrolled systemic infection; (9) acute variceal hemorrhage with MELD score ≥30 and/or arterial lactate \>12 mmol/L, or presentation with acute-on-chronic liver failure (ACLF); (10) severe or refractory overt hepatic encephalopathy in the absence of a correctable spontaneous portosystemic shunt; (11) systemic conditions requiring ongoing systemic treatment with glucocorticoids or nonsteroidal anti-inflammatory drugs (NSAIDs).

Where this trial is running

Xi'an, Shaanxi

• 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.

Conditions Liver Cirrhosis; Gastroesophageal Varices Bleeding; Esophageal and gastric variceal bleeding; Transjugular intrahepatic portosystemic shunt; Hepatic encephalopathy