Comparing endoscopic variceal ligation and carvedilol to prevent bleeding in liver cancer patients
Official title: A Randomized Controlled Trial of Endoscopic Variceal Ligation Versus Carvedilol for the Prevention of First Esophageal Variceal Bleeding in Patients With Hepatocellular Carcinoma
Run by Taipei Veterans General Hospital, Taiwan · NCT06594744 · Data updated 2026-11-12
This study is testing whether a procedure called endoscopic variceal ligation or a daily medication called carvedilol is better at preventing bleeding in liver cancer patients with high-risk varices.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 20 Years to 90 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Taipei Veterans General Hospital, Taiwan Government |
| Locations | 1 site (Taipei) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | October 2030 |
| Study ends | October 2030 |
| Registry record updated | February 13, 2025 |
| Trial ID | NCT06594744 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients aged 20 to 90 with hepatocellular carcinoma and high-risk esophageal varices.
✕Probably not a fit
Patients with a history of esophageal variceal bleeding or those with contraindications to non-selective beta-blockers may 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 evaluate the effectiveness of endoscopic variceal ligation (EVL) versus carvedilol in preventing the first episode of esophageal variceal bleeding (EVB) in patients diagnosed with hepatocellular carcinoma (HCC) who have high-risk esophageal varices. Participants will either undergo EVL every 3-4 weeks until variceal eradication or take carvedilol daily, with regular follow-ups and monitoring for safety and efficacy. The study seeks to address the lack of randomized controlled trials comparing these two prevention strategies in this high-risk population.
Why it matters
Potential benefit: If successful, this study could provide a more effective prevention strategy for esophageal variceal bleeding in patients with hepatocellular carcinoma, potentially improving survival rates.
How similar studies have gone: Previous studies have shown that endoscopic variceal ligation is superior to propranolol for preventing variceal bleeding in similar patient populations, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Patients with HCC and high-risk EVs, confirmed through imaging and clinical data (classified as F2 or F3 EVs according to Beppu et al. classification) Exclusion Criteria: * Age less than 20 years or greater than 90 years. * History of esophageal variceal bleeding. * Previous treatment for EVs, including EVL, endoscopic sclerotherapy, transjugular intrahepatic portosystemic shunt (TIPS), or surgical interventions. * Use of non-selective β-blockers within two weeks prior to enrollment. * Contraindications for non-selective β-blockers, including severe atrioventricular block, chronic obstructive pulmonary disease (COPD), asthma, poorly controlled diabetes, and severe peripheral artery disease. * Presence of other end-stage organ diseases, including terminal cancers other than HCC, heart failure, and renal failure. * Pregnant women.
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.