Carvedilol and Endoscopic Variceal Ligation for High-Risk Esophageal Varices in Hepatocellular Carcinoma
Carvedilol Tablets
+ Endoscopic Variceal Ligation
Adenocarcinoma+8
+ Carcinoma
+ Digestive System Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy 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
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, IndiaOpen Institute of Liver & Biliary Sciences (ILBS) in Google Maps