Condition category
Circulatory System
Date applied
28/12/2005
Date assigned
24/03/2006
Last edited
13/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

2009 pub in http://www.ncbi.nlm.nih.gov/pubmed/19218249

Publication citations

  1. 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.

Additional files

Editorial Notes