Carvedilol drug Versus Combination of carvedilol drug and Endoscopic Variceal Ligation (a procedure) for liver cancer patients.

Comparative Study of Carvedilol Monotherapy Versus Combination Therapy With Endoscopic Variceal Ligation (EVL) for Primary Prophylaxis of Variceal Bleeding in Patients With Hepatocellular Carcinoma With High-Risk Esophageal Varices: A Randomized Trial. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079806

Enrollment

100

Registered

2025-01-30

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Health Condition 1: K769- Liver disease, unspecified

Interventions

Intervention1: NSBB with EVL: Non-selective beta blocker (Carvedilol 3.125 mg BD for 3 days followed by 6.25 mg BD , maximum dose would be 12.5 mg BD , same shall be switch to maximum tolerable dose i

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-80 years 2. Cirrhosis with HCC 3. High risk oesophageal varices (large or small with RCS) 4. Valid consent

Exclusion criteria

Exclusion criteria: 1. Any contra-indication to beta-blockers 2. Any EVL or Sclerotherapy within last 3 months 3. Any past history of TIPS or surgery for portal hypertension 4. HCC with BCLC-D 5. Patients with past history of variceal bleed. 6. Patient With Liver transplant expected in next 2 weeks would be excluded

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of combination of Carvedilol with EVL over Carvedilol in prevention of index variceal bleed in a period of 6 months follow up among cirrhosis patients with HCC and high risk esophageal varices.Timepoint: 6 months	—

Secondary

Measure	Time frame
To study the impact of PVTT on Variceal bleedTimepoint: 6 months;Post EVL Ulcer bleed incidence and outcomeTimepoint: 6 months;To study effect of beta blocker on non invasive test for portal hypertension -LSM, SSM, APRI Score, ALBI Score and FIB-4,D-Dimer.Timepoint: 6 months;To study impact of locoregional therapy like SBRT on variceal bleed.Timepoint: 6 months;To study the impact of TKI/Immunotherapy on variceal bleed.Timepoint: 6 months	—

Measure

Time frame

To study the impact of PVTT on Variceal bleedTimepoint: 6 months;Post EVL Ulcer bleed incidence and outcomeTimepoint: 6 months;To study effect of beta blocker on non invasive test for portal hypertension -LSM, SSM, APRI Score, ALBI Score and FIB-4,D-Dimer.Timepoint: 6 months;To study impact of locoregional therapy like SBRT on variceal bleed.Timepoint: 6 months;To study the impact of TKI/Immunotherapy on variceal bleed.Timepoint: 6 months

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Countries

India

Contacts

Public ContactDr Ashok Choudhury

Institute of Liver and Biliary Sciences

doctor.ashokchoudhury@gmail.com01146300000

Outcome results

None listed

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