Recruiting

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

ClinicalTrials.gov IDNCT06594783

PhasePHASE4

Enrollment80

SponsorTaipei Veterans General Hospital, Taiwan

Age18 Years – 90 Years

SexALL

I'm interested View official listing

Conditions studied

Cirrhosis, Esophageal Varices

About this study

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.

Interventions

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

Primary outcomes

Esophageal variceal bleeding (3 years)

Eligibility information

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.

Study locations

Taipei Veterans General Hospital, Taipei, 11217 Taiwan

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-23.