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A study to assess the Endoscopic Treatment and Carvedilol Versus Carvedilol alone for Primary Prophylaxis of Patients With Hepatocellular Carcinoma and Esophageal Varice

Combination of Endoscopic Treatment and Carvedilol Versus Carvedilol alone for Primary Prophylaxis of Patients With Hepatocellular Carcinoma and Esophageal Varices- An open-label parallel group randomized control trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079115
Enrollment
220
Registered
2025-01-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: carvedilol at 3.125 mg twice daily and endoscopic band ligation: All patients in this arm will be started on carvedilol at 3.125 mg twice daily. The dose will be titrated every 7 days i

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 2. Cirrhotic patients with HCC (diagnosed based on the American Association for the Study of Liver Diseases criteria), including all BCLC classes 3. High-risk esophageal varices

Exclusion criteria

Exclusion criteria: of esophageal variceal bleeding 2. Patients planned to receive Atezolizumab plus Bevacizumab (immune checkpoint inhibitor plus anti-VEGF antibody based therapy) for the management of HCC 3. Patients classified as BCLC-D (based on the tumor burden, performance status of the patient and liver functions) 4. Patients with acute-on-chronic liver failure (based on EASL-CLIF consortium definition or APASL definition)(16,17) 5. Previous treatment for esophageal varices, including EBL, endoscopic injection sclerotherapy (EIS) or TIPSS 6. History of use of NSBBs 2 weeks before the enrolment 7. Contraindications to carvedilol (atrioventricular block, heart failure, chronic obstructive pulmonary disease, asthma or severe peripheral arterial disease) 8. Pregnancy 9. Not willing to give consent

Design outcomes

Primary

MeasureTime frame
1.To assess the cumulative incidence of first esophageal variceal bleeding among patients with HCC receiving carvedilol and EBL for primary prophylaxis as compared to carvedilol alone.Timepoint: 1 year—

Secondary

MeasureTime frame
1. To assess the cumulative incidence of upper gastrointestinal (UGI) bleeding 2. To compare the incidence of non-bleeding liver-related decompensations 3. To compare the overall survival between the two groups 4. To compare the rate of adverse events between the 2 groups 5. To compare the quality of life between the two groups Timepoint: 1. 1 year 2. 1 year 3. 1 year 4. 1 year 5. 1 year—

Countries

India

Contacts

Public ContactDr Shalimar

All India Institute of Medical Sciences

sjthedarknight@gmail.com9536045327

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026