Status:
RECRUITING
Carvedilol Plus EVL or Not for the Primary Prevention of Esophageal Variceal Bleeding in Carvedilol Non-responders
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Conditions:
Cirrhosis
Esophageal Varices
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to evaluate whether carvedilol plus endoscopic variceal ligation (EVL) is more effective for the primary prevention of esophageal variceal bleeding than carvedilol a...
Detailed Description
Gastro-esophageal variceal bleeding is a major complication of portal hypertension and carries a high rate of rebleeding and mortality. How to prevent the first esophageal variceal bleeding (EVB) in p...
Eligibility Criteria
Inclusion
- \- Cirrhotic patients with esophageal varices who, after carvedilol treatment, continue to experience variceal enlargement or develop new red color signs.
Exclusion
- Age under 18 or over 90 years.
- History of esophageal variceal bleeding.
- Previous treatment for esophageal varices, including endoscopic variceal ligation, endoscopic sclerotherapy, transjugular intrahepatic portosystemic shunt, or surgery.
- Contraindications to non-selective beta-blockers, including severe atrioventricular block, chronic obstructive pulmonary disease (COPD), asthma, uncontrolled diabetes mellitus, or severe peripheral artery disease.
- Presence of end-stage organ diseases, including hepatocellular carcinoma or other terminal cancers, heart failure, or renal failure.
- Pregnant women.
- Refusal to participate in the study.
Key Trial Info
Start Date :
January 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06594783
Start Date
January 6 2025
End Date
October 1 2030
Last Update
February 11 2025
Active Locations (1)
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1
Taipei Veterans General Hospital
Taipei, Taiwan, 11217