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From the interim analysis resulted that more than 1000 patients were required to demonstrate a significant difference between the 2 treatments.
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Whether beta-blockers or banding is the best therapy for primary prophylaxis of variceal bleeding is subject to debate. A randomized comparison between the two treatments was performed in candidates for liver transplantation. Patients with Child B and C cirrhosis with high risk varices and no previous variceal bleeding are randomized to propranolol or variceal bleeding. Primary end point is variceal bleeding
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic variceal banding | Procedure | |||
| propranolol | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| variceal bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Norberto, prof, M.D. | University of Padova, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic | Principal Investigator |
| Umberto Cillo, prof. M.D. | University of Padova, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic | Principal Investigator |
| Francesco Grigoletto, prof, M.D. | Biostatistic and Epidemiology Unit, Department of Enviromental Medicine and Public Health, University of Padova, Italy | Study Director |
| Davide D'Amico, prof, MD | Padova University, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Chirurgica 1^, Policlinico Universitario, Via Giustiniani 2 | Padova | 35128 | Italy |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D004932 | Esophageal and Gastric Varices |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D006975 | Hypertension, Portal |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |