Back to resultsBanding 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
About this trial
This is an interventional prevention trial for Liver Cirrhosis
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
Sites / Locations
- Clinica Chirurgica 1^, Policlinico Universitario, Via Giustiniani 2
Outcomes
Primary Outcome Measures
variceal bleeding
Secondary Outcome Measures
Full Information
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
undefined (undefined)
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
Learn more about this trial
Banding Versus Propranolol for Primary Prophylaxis of Variceal Bleeding
We'll reach out to this number within 24 hrs