NCT06836778Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 20 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 27 Jan 2025
- Start date
- 20 Feb 2025
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06836778
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 20 Feb 2025 to the primary completion date, 31 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient With Liver transplant expected in next 2 weeks would be excluded
Other illness
- Any past history of TIPS or surgery for portal hypertension
- Patients with past history of variceal bleed.
Other
- Any contra-indication to beta-blockers
- Any EVL or Sclerotherapy within last 3 months
- HCC with BCLC-D
Who the study is looking for
- Age 18-80 years
- Cirrhosis with HCC
- High risk oesophageal varices (\*large or small with RCS)
- Valid consent
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Liver & Biliary Sciences (ILBS) Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.