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Banding Versus Propranolol for Primary Prophylaxis of Variceal Bleeding

This study has been terminated.
(From the interim analysis resulted that more than 1000 patients were required to demonstrate a significant difference between the 2 treatments.)
Sponsor:
Information provided by:
University of Padova
ClinicalTrials.gov Identifier:
NCT00337740
First received: June 14, 2006
Last updated: April 20, 2012
Last verified: September 2006

June 14, 2006
April 20, 2012
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variceal bleeding
Same as current
Complete list of historical versions of study NCT00337740 on ClinicalTrials.gov Archive Site
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Banding Versus Propranolol for Primary Prophylaxis of Variceal Bleeding
Randomized Study Comparing Ligation With Propranolol for Primary Prophylaxis of Variceal Bleeding in Candidates for Liver Transplantation

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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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Liver Cirrhosis
  • Esophageal Varices
  • Procedure: endoscopic variceal banding
  • Drug: propranolol
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
120
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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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00337740
TCPSVECE/9/01PD
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University of Padova
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Principal Investigator: 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
Study Director: Francesco Grigoletto, prof, M.D. Biostatistic and Epidemiology Unit, Department of Enviromental Medicine and Public Health, University of Padova, Italy
Study Chair: Davide D'Amico, prof, MD Padova University, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic
University of Padova
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP