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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• \- Cirrhotic patients with esophageal varices who, after carvedilol treatment, continue to experience variceal enlargement or develop new red color signs.

Locations
Other Locations
Taiwan
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
Tsung-Chieh Yang, MD
tcyang@vghtpe.gov.tw
886-2-28712121
Backup
Ming-Chih Hou, MD
mchou@vghtpe.gov.tw
886-2-28712121
Time Frame
Start Date: 2025-01-06
Estimated Completion Date: 2030-10
Participants
Target number of participants: 80
Treatments
Active_comparator: 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.
Placebo_comparator: Carvedilol alone
Take carvedilol alone every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable).
Sponsors
Leads: Taipei Veterans General Hospital, Taiwan

This content was sourced from clinicaltrials.gov

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