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
  Purpose

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


Condition Intervention Phase
Liver Cirrhosis
Esophageal Varices
Procedure: endoscopic variceal banding
Drug: propranolol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Study Comparing Ligation With Propranolol for Primary Prophylaxis of Variceal Bleeding in Candidates for Liver Transplantation

Resource links provided by NLM:


Further study details as provided by University of Padova:

Primary Outcome Measures:
  • variceal bleeding

Estimated Enrollment: 120
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337740

Locations
Italy
Clinica Chirurgica 1^, Policlinico Universitario, Via Giustiniani 2
Padova, Italy, 35128
Sponsors and Collaborators
University of Padova
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00337740     History of Changes
Other Study ID Numbers: TCPSVECE/9/01PD
Study First Received: June 14, 2006
Last Updated: April 20, 2012
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Esophageal and Gastric Varices
Hemorrhage
Liver Cirrhosis
Fibrosis
Varicose Veins
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on August 26, 2014