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A randomized phase IV clinical trial comparing Nadolol and Isosorbide Mononitrate (ISMN) with the combination of Endoscopic Banding Ligation plus Nadolol and ISMN in the prevention of variceal rebleeding
ISRCTN ISRCTN26221020
DOI 10.1186/ISRCTN26221020
ClinicalTrials.gov identifier
EudraCT number
Public title A randomized phase IV clinical trial comparing Nadolol and Isosorbide Mononitrate (ISMN) with the combination of Endoscopic Banding Ligation plus Nadolol and ISMN in the prevention of variceal rebleeding
Scientific title
Acronym N/A
Serial number at source LEB-VE2002
Study hypothesis The combination of endoscopic banding ligation with drug therapy improves the results of drug therapy alone in the prevention of rebleeding in patients with cirrhosis who have suffered an acute variceal bleeding. The assumptions for the sample size were that the control group would have a 32% incidence of rebleeding at one-year, and that this would be reduced to 15% in the experimental group. Since this is a one sided hypothesis, we calculated that with an alpha of 5% and a beta of 20%, at least 160 patients would be required to detect such a difference.
Lay summary
Ethics approval Date of approval by the ethics committee: 23/Sep/2002. Number: 02-0294.
Study design Randomized controlled multicenter open study
Countries of recruitment Spain
Disease/condition/study domain Variceal bleeding
Participants - inclusion criteria 1. Age between 18-75
2. Diagnosis of cirrhosis
3. Hematemesis or melena within 7 days prior to inclusion
4. Esophageal or gastroesophageal varices as the source of bleeding
5. Written informed consent
6. Exclusion of pregnancy in woman of child-bearing potential
Participants - exclusion criteria 1. Hepatocellular carcinoma >5 cm or multinodular
2.Creatinine >2 mg/dl
3. Child-Pugh ≤13 points
4. Contraindications to beta-adrenergic blockers
5. Contraindications to ISMN
6. Banding ligation in the 3 months before the present episode of variceal bleeding
7. Previous portosystemic derivative therapy
8. Bleeding from fundal or ectopic varices
9. Total portal vein thrombosis or portal vein cavernomatosis
10. The patient was already on beta-adrenergic blockers and ISMN for the prevention of variceal bleeding
Anticipated start date 01/02/2003
Anticipated end date 01/02/2005
Status of trial Completed
Patient information material
Target number of participants 160 patients
Interventions Control group: nadolol + isosorbide mononitrate for the prevention of rebleeding
Experimental group: nadolol + isosorbide mononitrate + endoscopic banding ligation for the prevention of rebleeding.
Primary outcome measure(s) Rebleeding from any source
Secondary outcome measure(s) 1. Rebleeding from esophageal varices
2. Rebleeding from other portal hypertensive sources
3. Death
4. Death from variceal bleeding
5. Death from rebleeding
6. Frequency of severe adverse events
7. Relation between changes in hepatic venous pressure gradient and clinical events
8. Development of any complication of portal hypertension or death
9. Changes in variceal size
10. Transfusion requirements
11. Requirement for alternative therapies
12. Costs
Sources of funding Health Investigation Fund (Fondo de Investigación Sanitaria), Ministry of Health, PI020739.
Trial website
Publications 2009 pub in http://www.ncbi.nlm.nih.gov/pubmed/19218249
Contact name Prof  Jaime  Bosch
  Address Liver Unit
Hospital Clinic
Villarroel 170
  City/town Barcelona
  Zip/Postcode 08036
  Country Spain
  Tel +34 (0)932275790
  Fax +34 (0)932279856
  Email jbosch@clinic.ub.es
Sponsor Individual Sponsor (Spain)
  Address Dr Jaime Bosch
Hepatic Hemodynamic Laboratory
Hospital Clinic
Villarroel 170
  City/town Barcelona
  Zip/Postcode 08036
  Country Spain
  Tel +34 (0)932275790
  Fax +34 (0)932279856
  Email jbosch@clinic.ub.es
Date applied 28/12/2005
Last edited 13/07/2009
Date ISRCTN assigned 24/03/2006
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