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Banding Versus Propranolol for Primary Prophylaxis of Variceal Bleeding

Primary Purpose

Liver Cirrhosis, Esophageal Varices

Status
Terminated
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
endoscopic variceal banding
propranolol
Sponsored by
University of Padova
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Cirrhosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: liver cirrhosis child pugh>=B7 studied for transplantation age between 18 an 65 ys no previous bleeding from varices signed informed consent Exclusion Criteria: esophageal varices less than F2 blue gastric varices previous variceal surgical or radiological or endoscopical treatment hepatocarcinoma portal vein thrombosis severe heart, respiratory or renal failure contraindications to betablockers treatment with nitrates, calcium antagonist or anti-arhythmic drugs that can not be suspended Pregnancy neoplasias non cooperation

Sites / Locations

  • Clinica Chirurgica 1^, Policlinico Universitario, Via Giustiniani 2

Outcomes

Primary Outcome Measures

variceal bleeding

Secondary Outcome Measures

Full Information

First Posted
June 14, 2006
Last Updated
April 20, 2012
Sponsor
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT00337740
Brief Title
Banding Versus Propranolol for Primary Prophylaxis of Variceal Bleeding
Official Title
Randomized Study Comparing Ligation With Propranolol for Primary Prophylaxis of Variceal Bleeding in Candidates for Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Terminated
Why Stopped
From the interim analysis resulted that more than 1000 patients were required to demonstrate a significant difference between the 2 treatments.
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators

Name of the Sponsor
University of Padova

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Esophageal Varices

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
endoscopic variceal banding
Intervention Type
Drug
Intervention Name(s)
propranolol
Primary Outcome Measure Information:
Title
variceal bleeding

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: liver cirrhosis child pugh>=B7 studied for transplantation age between 18 an 65 ys no previous bleeding from varices signed informed consent Exclusion Criteria: esophageal varices less than F2 blue gastric varices previous variceal surgical or radiological or endoscopical treatment hepatocarcinoma portal vein thrombosis severe heart, respiratory or renal failure contraindications to betablockers treatment with nitrates, calcium antagonist or anti-arhythmic drugs that can not be suspended Pregnancy neoplasias non cooperation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenzo Norberto, prof, M.D.
Organizational Affiliation
University of Padova, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Umberto Cillo, prof. M.D.
Organizational Affiliation
University of Padova, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Grigoletto, prof, M.D.
Organizational Affiliation
Biostatistic and Epidemiology Unit, Department of Enviromental Medicine and Public Health, University of Padova, Italy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Davide D'Amico, prof, MD
Organizational Affiliation
Padova University, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Clinica Chirurgica 1^, Policlinico Universitario, Via Giustiniani 2
City
Padova
ZIP/Postal Code
35128
Country
Italy

12. IPD Sharing Statement

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Banding Versus Propranolol for Primary Prophylaxis of Variceal Bleeding

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