NCT06836778

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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)
PROCEDURE	Endoscopic Variceal Ligation	EVL every 3 weeks till eradication of varices followed by every 3 months.

Timeline

• Start date: 2025-02-20
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2025-02-20
• Last updated: 2025-02-20

Locations

1 site across 1 country: India