RecruitingPhase 4NCT06594744

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

A Randomized Controlled Trial of Endoscopic Variceal Ligation Versus Carvedilol for the Prevention of First Esophageal Variceal Bleeding in Patients With Hepatocellular Carcinoma


Sponsor

Taipei Veterans General Hospital, Taiwan

Enrollment

120 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate whether endoscopic variceal ligation (EVL) or carvedilol is more effective at preventing the first esophageal variceal bleeding (EVB) in patients with hepatocellular carcinoma (HCC). It will also learn about the safety of EVL and carvedilol in patients with HCC. The main questions it aims to answer are: Whether EVL or carvedilol is more effective at preventing initial EVB in patients with HCC with high-risk EVs. What medical problems do participants have when undergoing EVL or taking carvedilol? Researchers will compare the efficacy and safety of EVL to carvedilol for the prevention of first EVB in patients with HCC. Participants will: Undergo EVL every 3-4 weeks until variceal eradication and then receive regular endoscopic follow-up according to the protocol, or Take carvedilol every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable). Visit the clinic once every 2-3 months for checkups and tests. Keep a diary of their vital signs (SBP, DBP, and HR) as well as symptoms.


Eligibility

Min Age: 20 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches to prevent the first episode of bleeding from enlarged veins in the esophagus (esophageal varices) in patients with liver cancer (HCC): endoscopic banding (tying off the veins with rubber bands) versus a beta-blocker pill called carvedilol. **You may be eligible if...** - You have been diagnosed with hepatocellular carcinoma (liver cancer) - You have high-risk enlarged veins in the esophagus confirmed on endoscopy (classified as F2 or F3) - You are between 20 and 90 years old - You have never bled from esophageal varices before - You have not had previous treatment for esophageal varices **You may NOT be eligible if...** - You have a history of bleeding from esophageal varices - You have had previous treatment for esophageal varices (banding, sclerotherapy, shunting, or surgery) - You have conditions that prevent taking beta-blockers (e.g., severe heart block, COPD, asthma, poorly controlled diabetes, severe peripheral artery disease) - You have another end-stage condition (heart failure, kidney failure, other terminal cancer) - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEndoscopic variceal ligation

EVL will be performed and repeated every 3 to 4 weeks until the EVs are eradicated. Following this, patients will undergo regular upper gastrointestinal endoscopic surveillance, initially every three months for a total of two sessions, then every six months for a total of two sessions, and subsequently annually. If EVs are found to recur during surveillance, additional EVL will be performed every 3 to 4 weeks until the varices are again eradicated endoscopically.

DRUGCarvedilol

The initial dosage of carvedilol is set at 6.25 mg daily. In the absence of hypotension (systolic blood pressure \< 90 mmHg), bradycardia (resting heart rate \< 55 beats per minute), or other adverse effects, hospitalized patients may have their dosage increased to 12.5 mg daily after 3 days, while outpatient patients may increase their dosage to 12.5 mg daily after 7 days. This dosage represents the target dose for the trial.


Locations(1)

Taipei Veterans General Hospital

Taipei, Taiwan

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NCT06594744


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