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 |
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DOI | https://doi.org/10.1186/ISRCTN26221020 |
Secondary identifying numbers | LEB-VE2002 |
- Submission date
- 28/12/2005
- Registration date
- 24/03/2006
- Last edited
- 25/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jaime Bosch
Scientific
Scientific
Liver Unit
Hospital Clinic
Villarroel 170
Barcelona
08036
Spain
Phone | +34 (0)932275790 |
---|---|
jbosch@clinic.ub.es |
Study information
Study design | Randomized controlled multicenter open study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Prevention |
Scientific 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 |
Study objectives | 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(s) | Date of approval by the ethics committee: 23/Sep/2002. Number: 02-0294. |
Health condition(s) or problem(s) studied | 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 |
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 study start date | 01/02/2003 |
Completion date | 01/02/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 75 Years |
Sex | Both |
Target number of participants | 160 patients |
Key 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 |
Key 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 |
Date of first enrolment | 01/02/2003 |
Date of final enrolment | 01/02/2005 |
Locations
Countries of recruitment
- Spain
Study participating centre
Liver Unit
Barcelona
08036
Spain
08036
Spain
Sponsor information
Individual Sponsor (Spain)
Not defined
Not defined
Dr Jaime Bosch
Hepatic Hemodynamic Laboratory
Hospital Clinic
Villarroel 170
Barcelona
08036
Spain
Phone | +34 (0)932275790 |
---|---|
jbosch@clinic.ub.es |
Funders
Funder type
Government
Health Investigation Fund (Fondo de Investigación Sanitaria), Ministry of Health, PI020739.
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | pub | 01/08/2009 | Yes | No |
Editorial Notes
25/10/2022: Internal review.