NCT07587671Not yet recruiting
Underdilated VCX-TIPS Versus EVL Plus NSBB for Secondary Prophylaxis of Variceal Bleeding in Cirrhosis
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
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 7 May 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- West China Hospital
- Diseases
- High blood pressure
- NCT number
- NCT07587671
What you commit to
- Study type: Interventional
- Planned participants: 240
- From 1 Aug 2026 to the primary completion date, 31 Mar 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous TIPS, surgical portosystemic shunt, BRTO, CARTO, PARTO, or other procedures that substantially alter portosystemic blood flow.
- Previous recurrent or refractory overt hepatic encephalopathy, or a history of West Haven grade II to IV overt hepatic encephalopathy unrelated to gastrointestinal bleeding.
Other illness
- Hemodynamic instability, persistent active bleeding, or need for immediate rescue TIPS, surgical hemostasis, or interventional radiologic hemostasis.
- 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.
- 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.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for the study or unable to complete follow-up.
Other
- 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.
- Pregnancy or breastfeeding.
- Absolute contraindication to EVL, NSBB, or TIPS.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital，Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The Second Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| West China Xiamen Hospital, Sichuan University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.