Banding Versus Propranolol for Primary Prophylaxis of Variceal Bleeding

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2006 by University of Padova. Recruitment status was Recruiting

First Received on June 14, 2006. Last Updated on June 15, 2006 History of Changes

Sponsor:	University of Padova
Information provided by:	University of Padova
ClinicalTrials.gov Identifier:	NCT00337740

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 III

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:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis Esophagus Disorders Liver Transplantation Varicose Veins

Drug Information available for: Propranolol hydrochloride Propranolol Dexpropranolol

U.S. FDA Resources

Further study details as provided by University of Padova:

Primary Outcome Measures:

variceal bleeding

Estimated Enrollment:	120
Study Start Date:	September 2001

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

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

Contacts

Contact: Lorenzo Norberto, prof

0039-0498212211

lorenzo.norberto@unipd.it

Locations

Italy
Clinica Chirurgica 1^, Policlinico Universitario, Via Giustiniani 2	Recruiting
Padova, Italy, 35128
Contact: Lorenzo Norberto, prof 0039-0498212211 lorenzo.norberto@unipd.it
Principal Investigator: Lorenzo Norberto, prof., M.D.
Principal Investigator: Umberto Cillo, prof. M.D.
Sub-Investigator: Giacomo Zanus, M.D.
Sub-Investigator: Lino Polese, M.D.
Sub-Investigator: Patrizia Burra, MD

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:	June 15, 2006
Health Authority:	Italy: Ministry of Health

Additional relevant MeSH terms:

Esophageal Diseases
Esophageal and Gastric Varices
Hemorrhage
Liver Cirrhosis
Fibrosis
Varicose Veins
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases

Propranolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents

ClinicalTrials.gov processed this record on February 09, 2012