Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07587671

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

Sponsor: West China Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Underdilated VIATORR Controlled Expansion Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Variceal Ligation Plus Nonselective Beta-Blockers for Secondary Prophylaxis of Variceal Bleeding in Patients With Cirrhosis: A Multicenter, Open-Label, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2026-08-01

Completion Date

2030-07-30

Last Updated

2026-05-14

Healthy Volunteers

Conditions

Liver Cirrhosis Portal Hypertension Gastroesophageal Varices Bleeding Esophageal Varices Hepatic Encephalopathy

Interventions

PROCEDURE

Underdilated VCX-TIPS

Transjugular intrahepatic portosystemic shunt will be created using a VIATORR Controlled Expansion 8-10 mm stent. The stent will initially be dilated only with a 6-mm balloon. Portal pressure gradient will be measured before and after shunt creation. Additional embolization of responsible variceal inflow vessels may be performed if clinically indicated. Further dilation to 8 mm will be reserved for predefined rescue situations.

PROCEDURE

Endoscopic Variceal Ligation

Serial endoscopic variceal ligation will be performed according to standardized endoscopic procedures. EVL will be repeated approximately every 4 weeks until variceal eradication or conversion to a low-risk status. For type 1 gastroesophageal varices with substantial gastric extension or high-risk bleeding stigmata, endoscopic tissue adhesive injection may be performed according to local standardized procedures.

DRUG

Nonselective Beta-Blockers

Carvedilol will be the preferred nonselective beta-blocker, starting at 6.25 mg once daily and increasing to 12.5 mg once daily after 1 week if tolerated. Dose adjustment, temporary discontinuation, or switching to propranolol will be allowed according to heart rate, blood pressure, renal function, infection status, and overall tolerability.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (3)

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