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

NCT ID: NCT06836778

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-20
• Study Completion Date: 2026-01-31

Brief Summary

Esophageal varices are common in patients with hepatocellular carcinoma (HCC), with an incidence rate of 63% at the time of HCC diagnosis. Following an acute variceal bleed, the 6-week mortality rate for HCC patients is as high as 26%. Mortality rates escalate notably in HCC patients experiencing acute variceal bleeding, especially with increasing cancer severity indicated by BLCL status. Research suggests that the cumulative incidence rate of variceal bleeding at one year in patients receiving primary prophylaxis is almost half that of patients not receiving any prophylaxis.

Beta blockers are the standard therapy for primary prophylaxis in patients with portal hypertension to prevent variceal bleeding. Endoscopic band ligation has also shown promising results in recent studies. However, the combined impact of beta blockers and esophageal band ligation on lowering the incidence of variceal bleeding remains unstudied.

The aim of this study is to compare the efficacy of carvedilol monotherapy versus combination therapy with carvedilol and endoscopic band ligation in patients with HCC for primary prophylaxis of high-risk esophageal varices.

Detailed Description

Study population: All patients aged ≥ 18 years and ≤ 80 years admitted in Institute of Liver and Biliary Sciences, New Delhi with HCC of any cause and high risk esophageal varices and are giving written consent for participation in the study.

Study design - Single center, Open label, Randomized controlled trial Study period - 6 months Intervention - The patients will be randomized into Group -A (NSBB arm) and Group-B (EVL + NSBB arm). Both the group will receive the remaining treatment as per protocol Group A: 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 if SBP< 90 , H,R<55) Group B: 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 if SBP< 90 , H,R<55) + EVL every 3 weeks till eradication of varices followed by every 3 months.

Monitoring and assessment: Monitoring and evaluation would be done once a month for first 3 months then at 6th month.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NSBB+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 if Systolic BP\< 90 , H,R\<55) + EVL every 3 weeks till eradication of varices followed by every 3 months

Group Type: EXPERIMENTAL

Carvedilol Tablets

Intervention Type: DRUG

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 if Systolic BP\< 90 , H,R\<55)

Endoscopic Variceal Ligation

Intervention Type: PROCEDURE

EVL every 3 weeks till eradication of varices followed by every 3 months.

NSBB

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 if Systolic BP\< 90 , H,R\<55)

Group Type: ACTIVE_COMPARATOR

Carvedilol Tablets

Intervention Type: DRUG

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 if Systolic BP\< 90 , H,R\<55)

Interventions

Carvedilol Tablets

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 if Systolic BP\< 90 , H,R\<55)

Intervention Type: DRUG

Endoscopic Variceal Ligation

EVL every 3 weeks till eradication of varices followed by every 3 months.

Intervention Type: PROCEDURE

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, India

Countries

India

Central Contacts

Dr Sarthak Chanana, MD

Role: CONTACT

xs2sarthak@gmail.com

01146300000

Dr Ashok Chaoudhury, DM

Role: CONTACT

doctor.ashokchoudhury@gmail.com

01146300000

Facility Contacts

Dr Sarthak Chanana, MD

Role: primary

xs2sarthak@gmail.com

01146300000

Other Identifiers

ILBS-HCC-08

Identifier Type: -

Identifier Source: org_study_id