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Clinical Trials in India / NCT06836778
Starting soon Not applicable

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 · tracked via the Priya Life Science India tracker
Sponsor
Institute of Liver and Biliary Sciences, India
Phase
Not applicable
Started
2025-02-20
Last updated
2025-02-20

Condition(s) studied

Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

Carvedilol TabletsEndoscopic Variceal Ligation

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)

Endoscopic Variceal Ligation: EVL every 3 weeks till eradication of varices followed by every 3 months.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Institute of Liver & Biliary Sciences (ILBS) New Delhi National Capital Territory of Delhi

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06836778 on ClinicalTrials.gov ↗ ← All trials in India