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Carvedilol versus endoscopic band ligation for the primary prevention of esophageal variceal bleeding in patients with hepatocellular carcinoma

Carvedilol versus endoscopic band ligation for the primary prevention of esophageal variceal bleeding in patients with hepatocellular carcinoma, multicenter RCT

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250917002
Enrollment
62
Registered
2025-09-17
Start date
2025-06-06
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary: Compare efficacy of Carvedilol vs. Endoscopic Band Ligation (EBL) in preventing esophageal variceal bleeding in liver cancer patients over 6 months Secondary: Compare survival, liver failure, non-variceal UGIB, and adverse events between Carvedilol and EBL groups. Esophageal band ligation Cirrhosis Carvedilol Hepatocellular carcinoma

Interventions

EBL is performed by gastroenterologists using Six-shooter Multi-band Ligator for patients with medium to large esophageal varices. Procedures are repeated every 4 weeks until variceal eradication. Che
Endoscopic band ligation,Carvedilol

Sponsors

Department of Gastroenterology and Hepatology, Faculty of Medicine, Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age 18 years or older 2.Hepatocellular carcinoma, BCLC stage 0 to D 3.Medium to large esophageal varices 4.Patients with cirrhosis of any Child-Pugh class

Exclusion criteria

Exclusion criteria: 1.History of esophageal variceal bleeding (portal hypertensive gastropathy or ectopic varices not excluded) 2.Previous treatment of esophageal varices 3.Use of non-selective beta blockers within 2 weeks 4.Contraindications to non-selective beta blockers 5.Pregnancy

Design outcomes

Primary

MeasureTime frame
Esophageal varice bleeding 6 month Event bleeding

Secondary

MeasureTime frame
Secondary Objectives: Compare survival, non-variceal upper GI bleeding, liver decompensation, and treatment-related adverse events between Carvedilol and EBL groups 6 month number of events

Countries

Thailand

Contacts

Public ContactThanatarn Sathidatekoonchorn

Chulalongkorn university

irnent2@gmail.com026494000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026