Clinical trial · Interventional
Non-selective Beta Blockers Versus EVL for Primary Prophylaxis of Esophageal Variceal Bleeding in Patients With Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis.
A Prospective Randomized Controlled Trial Comparing Non-selective Beta Blockers Versus EVL for Primary Prophylaxis of Esophageal Variceal Bleeding in Patients With Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to high mortality
Summary
Brief summary (as posted)
Every patient with HCC (Hepato-Cellular Carcinoma) with main portal vein thrombosis will be screened for presence of large esophageal varices and will be randomized between non-selective beta blocker versus primary endoscopic variceal ligation. They will be followed to assess the rate of reduction of index bleed rate as well as survival difference between the groups.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma With Portal Vein Thrombosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carvedilol | Drug | — | UNRESOLVED |
| Endoscopic Variceal Ligation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endoscopic Variceal Ligation
- description
- Endoscopic Variceal Ligation every 3 weeks till eradication
- interventionNames
- Procedure: Endoscopic Variceal Ligation
- type
- ACTIVE_COMPARATOR
- label
- Carvedilol
- description
- Carvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD
- interventionNames
- Drug: Carvedilol
Primary outcomes (1)
- measure
- First Variceal Bleeding
- timeFrame
- 1.5 years
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients of cirrhosis with Hepatocellular carcinoma and portal vein thrombosis * Presence of large oesophageal varices or small with high risk Exclusion Criteria: * Any contra-indication to beta-blockers * Any Endoscopic Variceal Ligation or Sclerotherapy within last 3 months * High risk gastric varices * Any past history of Transhepatic Intrajugular Portosystemic Shunt or surgery for portal hypertension * Significant cardio or pulmonary co-morbidity * Any extrahepatic malignancy * Patients with past history of variceal bleed * Patients with non-tumor portal vein thrombosis * Refusal to participate in the study
References
Publications (0)
Data not yet available