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 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

Liver Unit
Hospital Clinic
Villarroel 170
Barcelona
08036
Spain

Phone +34 (0)932275790
Email jbosch@clinic.ub.es

Study information

Study designRandomized controlled multicenter open study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific titleA 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 objectivesThe 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) studiedVariceal bleeding
InterventionControl group: nadolol + isosorbide mononitrate for the prevention of rebleeding
Experimental group: nadolol + isosorbide mononitrate + endoscopic banding ligation for the prevention of rebleeding.
Intervention typeOther
Primary outcome measureRebleeding from any source
Secondary outcome measures1. 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 date01/02/2003
Completion date01/02/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit75 Years
SexBoth
Target number of participants160 patients
Key inclusion criteria1. 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 criteria1. 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 enrolment01/02/2003
Date of final enrolment01/02/2005

Locations

Countries of recruitment

  • Spain

Study participating centre

Liver Unit
Barcelona
08036
Spain

Sponsor information

Individual Sponsor (Spain)
Not defined

Dr Jaime Bosch
Hepatic Hemodynamic Laboratory
Hospital Clinic
Villarroel 170
Barcelona
08036
Spain

Phone +34 (0)932275790
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article pub 01/08/2009 Yes No

Editorial Notes

25/10/2022: Internal review.