RecruitingPhase 4NCT06594783

Carvedilol Plus EVL or Not for the Primary Prevention of Esophageal Variceal Bleeding in Carvedilol Non-responders

Carvedilol Plus Endoscopic Ligation or Not for the Primary Prevention of Esophageal Variceal Bleeding in Carvedilol Non-responders: a Randomized Controlled Trial


Sponsor

Taipei Veterans General Hospital, Taiwan

Enrollment

80 participants

Start Date

Jan 6, 2025

Study Type

INTERVENTIONAL

Conditions

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 alone in carvedilol non-responders. It will also learn about the safety of carvedilol combined with EVL in patients with cirrhosis. The main questions it aims to answer are: Whether carvedilol plus EVL is more effective than carvedilol alone in preventing the first esophageal variceal bleeding in cirrhotic patients unresponsive to carvedilol. What medical problems do participants have when taking carvedilol or taking carvedilol combined with undergoing EVL? Researchers will compare the efficacy and safety of carvedilol with or without EVL in preventing the first esophageal variceal bleeding in cirrhotic patients unresponsive to carvedilol. Participants will: Take carvedilol every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable) and undergo EVL every 3-4 weeks until variceal eradication followed by regular endoscopic follow-up according to the protocol, or Take carvedilol alone 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: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding endoscopic banding (physically tying off veins with rubber bands) to carvedilol (a blood pressure pill) can better prevent esophageal variceal bleeding in cirrhosis patients who did not respond well enough to carvedilol alone. **You may be eligible if...** - You have cirrhosis (scarred liver) with esophageal varices - You are currently on carvedilol, but your varices are still growing or developing new warning signs despite treatment - You are between 18 and 90 years old - You have never had a bleeding episode from esophageal varices - You have not had previous variceal treatment procedures **You may NOT be eligible if...** - You have a history of esophageal variceal bleeding - You have had previous endoscopic, surgical, or shunting procedures for varices - You have COPD, asthma, severe heart block, uncontrolled diabetes, or severe peripheral artery disease - You have end-stage organ failure (heart, kidney, or liver cancer) - You are pregnant - You decline to participate 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

OTHERCarvedilol plus endoscopic variceal ligation

Take carvedilol every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable) and undergo EVL every 3-4 weeks until variceal eradication followed by regular endoscopic follow-up according to the protocol.

DRUGCarvedilol alone

Take carvedilol alone every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable).


Locations(1)

Taipei Veterans General Hospital

Taipei, Taiwan

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NCT06594783


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