Smaller-Opening Liver Shunt Versus Banding Plus Beta-Blockers to Prevent Repeat Varicose Bleeding in Cirrhosis
Compares two ways to prevent repeat bleeding from swollen veins in people with cirrhosis.
Plain-language title generated from the registry record
Registry title: Underdilated VCX-TIPS Versus EVL Plus NSBB for Secondary Prophylaxis of Variceal Bleeding in Cirrhosis
Key facts
- Where
- Chengdu, Chongqing, and Xiamen, ChinaSee the 3 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with cirrhosis who bled from varices in the food pipe or upper stomach, have stopped bleeding, and need treatment to prevent new bleeding.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Liver cirrhosis with Child-Pugh score of 5 to 13. A recent bleed from esophageal varices or type 1 gastroesophageal varices, now controlled with stable vital signs.
- Earlier treatment
- Standard treatment of the acute bleed must have stopped the bleeding. No earlier TIPS, surgical shunt, BRTO, CARTO, PARTO or similar procedure that changes blood flow.
Main reasons for not taking part
- Ongoing bleeding or unstable blood circulation
- Child-Pugh score greater than 13
- Earlier TIPS or surgical shunt, or other procedures that change blood flow
- Earlier repeated or hard-to-treat overt hepatic encephalopathy, or West Haven grade II to IV
- Pregnancy or breastfeeding
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07587671, who can take part
Where in China
- West China Hospital，Sichuan UniversityChengdu, ChinaContact: Xiaoze Wang, MDNo longer taking part
- The Second Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaContact: Yongjun Zhu, MDNo longer taking part
- West China Xiamen Hospital, Sichuan UniversityXiamen, ChinaContact: Bingcan Yang, MDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- West China Hospital
- Trial code
- NCT07587671
- Record updated
- 14 May 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; 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; 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.