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

NCT06836778 | Not Yet Recruiting

• 1 other identifier: ILBS-HCC-08
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Proportion of patients of cirrhosis with HCC and high risk oesophageal varices on carvedilol developing variceal bleed with or without EVL in 6months follow up.

  6 months

Secondary Outcomes (6)

• Proportion of patient developing variceal bleed while on therapy with Tyrosine Kinase Inhibitors despite on carvedilol with or without EVL

  6 months

• Proportion of patient developing variceal bleed while on therapy with immunotherapy despite on carvedilol with or without EVL.

  6 months

• Percentage of patient of cirrhosis with HCC and Portal Vein Tumoral Thrombosis developing variceal bleed while on carvedilol with or without EVL.

  6 months

• Proportion of patients having post-EVL ulcer bleed after endoscopic variceal ligation.

  6 months

• Proportion of patients with change in non invasive test for portal hypertension in both groups.

  6 months

Study Arms (2)

NSBB+EVL

EXPERIMENTAL

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

Drug: Carvedilol Tablets; Procedure: Endoscopic Variceal Ligation

NSBB

ACTIVE COMPARATOR

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)

Drug: Carvedilol Tablets

Interventions

Carvedilol Tablets 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)

NSBB; NSBB+EVL

Endoscopic Variceal Ligation PROCEDURE

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

NSBB+EVL

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years
• Cirrhosis with HCC
• High risk oesophageal varices (\*large or small with RCS)
• Valid consent

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Dr Sarthak Chanana, MD

CONTACT

01146300000; xs2sarthak@gmail.com

Dr Ashok Chaoudhury, DM

CONTACT

01146300000; doctor.ashokchoudhury@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 20, 2025
• Study Start: February 20, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: February 20, 2025

Record last verified: 2025-01

Locations

IN (1)