Underdilated VCX-TIPS Versus EVL Plus NSBB for Secondary Prophylaxis of Variceal Bleeding in Cirrhosis

Starting soon · Not applicable

Conditions studied: Liver Cirrhosis, Portal Hypertension, Gastroesophageal Varices Bleeding, Esophageal Varices, Hepatic Encephalopathy

In brief

Variceal bleeding is a major complication of portal hypertension in patients with cirrhosis and is associated with substantial risks of rebleeding and death. Current guidelines recommend endoscopic variceal ligation combined with nonselective beta-blockers as standard secondary prophylaxis for esophageal variceal bleeding and type 1 gastroesophageal variceal bleeding. Transjugular intrahepatic portosystemic shunt can markedly reduce portal pressure and prevent recurrent variceal bleeding, but its broader use in secondary prophylaxis is limited by the risk of post-TIPS hepatic encephalopathy and liver function deterioration. The VIATORR Controlled Expansion stent is designed to allow controlled expansion between 8 and 10 mm. However, even 8-mm TIPS may still be associated with a substantial risk of overt hepatic encephalopathy. This trial evaluates an underdilated VCX-TIPS strategy, in which a commercially available 8-10 mm VIATORR Controlled Expansion stent is initially dilated only with a 6-mm balloon, aiming to achieve sufficient portal decompression while reducing the risk of excessive shunting. This is a prospective, multicenter, open-label, parallel-group, randomized superiority trial. Eligible patients with cirrhosis who have recovered from acute esophageal variceal bleeding or type 1 gastroesophageal variceal bleeding and have entered the secondary prophylaxis phase will be randomly assigned in a 1:1 ratio to receive either underdilated VCX-TIPS or endoscopic variceal ligation plus nonselective beta-blockers. The primary outcome is the composite of all-cause death or clinically significant upper gastrointestinal rebleeding within 1 year after randomization.

Key facts

Study ID

NCT07587671

Run by

West China Hospital

People needed

240

Starts

2026-08-01

Expected to finish

2030-07-30

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 to 75 years, regardless of sex.
• Diagnosis of liver cirrhosis based on previous histology, imaging, laboratory tests, and/or clinical manifestations.
• Hospitalization for acute upper gastrointestinal bleeding, with endoscopic confirmation that the bleeding is related to esophageal varices or type 1 gastroesophageal varices.
• Successful control of acute bleeding after standard acute-phase treatment, with stable vital signs and entry into the secondary prophylaxis phase.
• Child-Pugh score of 5 to 13.
• The investigator judges that both underdilated VCX-TIPS and EVL plus NSBB are clinically feasible and that randomization is appropriate.
• The participant or legally authorized representative understands the study procedures and voluntarily signs written informed consent.

You may not qualify if…

• Hemodynamic instability, persistent active bleeding, or need for immediate rescue TIPS, surgical hemostasis, or interventional radiologic hemostasis.
• A strong current indication for early or pre-emptive TIPS that makes randomization to EVL plus NSBB clinically inappropriate.
• Child-Pugh score greater than 13.
• Previous TIPS, surgical portosystemic shunt, BRTO, CARTO, PARTO, or other procedures that substantially alter portosystemic blood flow.
• Isolated gastric varices, type 2 gastroesophageal varices, ectopic varices, or a bleeding source other than esophageal varices or type 1 gastroesophageal varices.
• Non-cirrhotic portal hypertension.
• Cavernous transformation of the portal vein or portal venous thrombosis that makes standardized TIPS technically infeasible.
• Previous recurrent or refractory overt hepatic encephalopathy, or a history of West Haven grade II to IV overt hepatic encephalopathy unrelated to gastrointestinal bleeding.
• Severe heart failure, severe pulmonary hypertension, severe tricuspid regurgitation, right heart failure, or other contraindications to TIPS.
• Uncontrolled severe infection, sepsis, or multiple organ failure.
• Hepatocellular carcinoma beyond the Milan criteria or other advanced malignancy.
• Severe renal insufficiency requiring long-term renal replacement therapy.
• Pregnancy or breastfeeding.
• Absolute contraindication to EVL, NSBB, or TIPS.
• Any condition that, in the investigator's judgment, makes the participant unsuitable for the study or unable to complete follow-up.

Where it is running

• West China Hospital, Sichuan University — Chengdu, China
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, China
• West China Xiamen Hospital, Sichuan University — Xiamen, China

Full record on ClinicalTrials.gov

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