Contact information
Type
Scientific
Primary contact
Prof Jaime Bosch
ORCID ID
Contact details
Liver Unit
Hospital Clinic
Villarroel 170
Barcelona
08036
Spain
+34 (0)932275790
jbosch@clinic.ub.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LEB-VE2002
Study information
Scientific title
Acronym
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.
Ethics approval
Date of approval by the ethics committee: 23/Sep/2002. Number: 02-0294.
Study design
Randomized controlled multicenter open study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Variceal bleeding
Intervention
Control group: nadolol + isosorbide mononitrate for the prevention of rebleeding
Experimental group: nadolol + isosorbide mononitrate + endoscopic banding ligation for the prevention of rebleeding.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Rebleeding from any source
Secondary outcome measures
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
Overall trial start date
01/02/2003
Overall trial end date
01/02/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160 patients
Participant 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
Recruitment start date
01/02/2003
Recruitment end date
01/02/2005
Locations
Countries of recruitment
Spain
Trial participating centre
Liver Unit
Barcelona
08036
Spain
Sponsor information
Organisation
Individual Sponsor (Spain)
Sponsor details
Dr Jaime Bosch
Hepatic Hemodynamic Laboratory
Hospital Clinic
Villarroel 170
Barcelona
08036
Spain
+34 (0)932275790
jbosch@clinic.ub.es
Sponsor type
Not defined
Website
Funders
Funder type
Government
Funder name
Health Investigation Fund (Fondo de Investigación Sanitaria), Ministry of Health, PI020739.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 pub in http://www.ncbi.nlm.nih.gov/pubmed/19218249
Publication citations
-
Pub
García-Pagán JC, Villanueva C, Albillos A, Bañares R, Morillas R, Abraldes JG, Bosch J, , Nadolol plus isosorbide mononitrate alone or associated with band ligation in the prevention of recurrent bleeding: a multicentre randomised controlled trial., Gut, 2009, 58, 8, 1144-1150, doi: 10.1136/gut.2008.171207.