Recruiting soon

Carvedilol and Endoscopic Variceal Ligation for High-Risk Esophageal Varices in Hepatocellular Carcinoma

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Carvedilol Tablets

+ Endoscopic Variceal Ligation

DrugProcedure
Who is being recruted

Adenocarcinoma+8

+ Carcinoma

+ Digestive System Diseases

From 18 to 80 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2025
See protocol details

Summary

Principal SponsorInstitute of Liver and Biliary Sciences, India
Study ContactDr Sarthak Chanana, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 20, 2025

Actual date on which the first participant was enrolled.

This study is investigating the best way to prevent bleeding from enlarged veins in the esophagus, known as varices, in patients who have liver cancer and are at high risk for such bleeding. The research focuses on comparing two treatment approaches: using a medication called Carvedilol alone, or combining it with a procedure called endoscopic variceal ligation (EVL). Carvedilol is a type of drug known as a non-selective beta blocker, which can help reduce blood pressure in the veins. The study aims to find out which method is more effective in preventing variceal bleeding, which is a serious complication for patients with liver cancer. Participants in this study are adults between 18 and 80 years old, all of whom have liver cancer and high-risk esophageal varices. They are randomly assigned to one of two groups. One group receives only Carvedilol, starting with a low dose and gradually increasing to the maximum tolerable dose. The other group receives the same Carvedilol treatment along with EVL, a procedure done every three weeks until the varices are removed, and then every three months. Participants are monitored monthly for the first three months and again at the sixth month to assess the effectiveness of the treatments. The study's goal is to determine which approach better prevents bleeding and improves patient outcomes.

Official TitleComparative 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
NCT06836778
Principal SponsorInstitute of Liver and Biliary Sciences, India
Study ContactDr Sarthak Chanana, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaDigestive System DiseasesDigestive System NeoplasmsCarcinoma, HepatocellularLiver DiseasesLiver NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and Epithelial

Criteria

4 inclusion criteria required to participate
Age 18-80 years

Cirrhosis with HCC

High risk oesophageal varices (*large or small with RCS)

Valid consent

6 exclusion criteria prevent from participating
Patient With Liver transplant expected in next 2 weeks would be excluded

Any contra-indication to beta-blockers

Any EVL or Sclerotherapy within last 3 months

Any past history of TIPS or surgery for portal hypertension

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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)

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, IndiaOpen Institute of Liver & Biliary Sciences (ILBS) in Google Maps
Recruiting soonOne Study Center