Non-selective Beta Blockers Versus EVL for Primary Prophylaxis of Esophageal Variceal Bleeding in Patients With Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis.
Overview[ - collapse ][ - ]
| Purpose | Every patient with HCC with main portal vein thrombosis will be screened for presence of large esophageal varices and will be randomised 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. |
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| Condition | Hepatocellular Carcinoma With Portal Vein Thrombosis |
| Intervention | Procedure: Endoscopic Variceal Ligation Drug: Carvedilol |
| Phase | N/A |
| Sponsor | Institute of Liver and Biliary Sciences, India |
| Responsible Party | Institute of Liver and Biliary Sciences, India |
| ClinicalTrials.gov Identifier | NCT01659346 |
| First Received | August 4, 2012 |
| Last Updated | December 16, 2013 |
| Last verified | December 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 4, 2012 |
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| Last Updated Date | December 16, 2013 |
| Start Date | August 2012 |
| Estimated Primary Completion Date | August 2014 |
| Current Primary Outcome Measures | First Variceal Bleeding [Time Frame: 2 years] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Non-selective Beta Blockers Versus EVL for Primary Prophylaxis of Esophageal Variceal Bleeding in Patients With Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis. |
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| Official Title | 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 |
| Brief Summary | Every patient with HCC with main portal vein thrombosis will be screened for presence of large esophageal varices and will be randomised 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Hepatocellular Carcinoma With Portal Vein Thrombosis |
| Intervention | Procedure: Endoscopic Variceal Ligation Endoscopic Variceal Ligation every 3 weeks till eradication. Drug: Carvedilol Carvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
|---|---|
| Estimated Enrollment | Not Provided |
| Estimated Completion Date | August 2014 |
| Estimated Primary Completion Date | August 2014 |
| Eligibility Criteria | 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Dr SM Shasthry, MD 011-46300000 shasthry@gmail.com |
| Location Countries | India |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01659346 |
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| Other Study ID Numbers | ILBS-HCC-01 |
| Has Data Monitoring Committee | No |
| Information Provided By | Institute of Liver and Biliary Sciences, India |
| Study Sponsor | Institute of Liver and Biliary Sciences, India |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Dr SM Shasthry, MD Institute of Liver and Biliary Sciences |
| Verification Date | December 2013 |
Locations[ + expand ][ + ]
| Institute of Liver and Biliary Sciences | New Delhi, Delhi, India, 110070 Contact: Dr SM Shasthry, MD | 011-46300000 | shasthry@gmail.comNot yet recruiting |
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