Evaluating carvedilol with or without endoscopic variceal ligation for preventing bleeding in cirrhotic patients
Official title: Carvedilol Plus Endoscopic Ligation or Not for the Primary Prevention of Esophageal Variceal Bleeding in Carvedilol Non-responders: a Randomized Controlled Trial
Run by Taipei Veterans General Hospital, Taiwan · NCT06594783 · Data updated 2026-11-12
This study is testing if adding a procedure called endoscopic variceal ligation to the medication carvedilol can better prevent bleeding in people with cirrhosis who aren't helped by carvedilol alone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Taipei Veterans General Hospital, Taiwan Government |
| Locations | 1 site (Taipei) |
| Status | Recruiting |
| Started | January 6, 2025 |
| Main results expected | October 2030 |
| Study ends | October 2030 |
| Registry record updated | February 11, 2025 |
| Trial ID | NCT06594783 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are cirrhotic patients with esophageal varices who continue to experience variceal enlargement despite carvedilol treatment.
✕Probably not a fit
Patients with a history of esophageal variceal bleeding or those with contraindications to non-selective beta-blockers will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to determine if combining carvedilol with endoscopic variceal ligation (EVL) is more effective than carvedilol alone in preventing esophageal variceal bleeding in patients with cirrhosis who do not respond to carvedilol. Participants will take carvedilol daily and undergo EVL every 3-4 weeks. The study will assess both the efficacy and safety of this combination treatment. It addresses a significant gap in treatment options for carvedilol non-responders, focusing on improving patient outcomes in a high-risk population.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of esophageal variceal bleeding in patients with cirrhosis who are unresponsive to standard carvedilol treatment.
How similar studies have gone: While studies on carvedilol's effectiveness are established, this specific combination with EVL in non-responders is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Cirrhotic patients with esophageal varices who, after carvedilol treatment, continue to experience variceal enlargement or develop new red color signs. Exclusion Criteria: * 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.
Where it's running
-
Taipei Veterans General Hospital
Taipei, Taiwan Recruiting
Study contacts
- Study coordinator: Tsung-Chieh Yang, MD
- Email: tcyang@vghtpe.gov.tw
- Phone: 886-2-28712121
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.