Endoscopic Variceal Ligation vs Carvedilol for the Prevention of First Esophageal Variceal Bleeding in Patients With HCC

Launched by TAIPEI VETERANS GENERAL HOSPITAL, TAIWAN · Sep 10, 2024

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ClinConnect Summary

This clinical trial is studying two different methods to prevent serious bleeding from enlarged veins in the esophagus (called esophageal varices) in patients with liver cancer (hepatocellular carcinoma or HCC). The researchers want to find out if a procedure called endoscopic variceal ligation (EVL), which involves tying off the varices, is more effective than taking a daily medication called carvedilol. They are also looking at how safe each of these options is for patients.

To be eligible for this trial, participants need to be adults aged 20 to 90 who have been diagnosed with HCC and have high-risk esophageal varices. Participants will receive the treatment they are randomly assigned to—either the EVL procedure every few weeks or the daily carvedilol medication. They will have regular check-ups every 2-3 months and will keep a diary to track their health and any symptoms they experience. It's important to know that individuals with certain medical conditions or previous treatments for varices may not qualify for this study.

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Eligibility 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.