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

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.

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.

Sponsors & Collaborators

• West China Xiamen Hospital

  collaborator UNKNOWN

• West China Tianfu Hospital

  collaborator OTHER

• Southwest Hospital, China

  collaborator OTHER

• The Second Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• The Second Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Chongqing Qianjiang Central Hospital

  collaborator UNKNOWN

• Chengdu Shangjin Nanfu Hospital

  collaborator UNKNOWN

• West China Hospital

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-01

Primary Completion

2029-03-31

Completion

2030-07-30

Countries

• China

Study Locations