Secondary Prophylaxis After Variceal Bleeding in Non-Responders

NCT ID: NCT00450164

Last Updated: 2007-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-11-30
• Study Completion Date: 2004-06-30

Brief Summary

Controlled and randomized study comparing combined treatment (nadolol and endoscopic ligation) versus nadolol associated with isosorbide mononitrate or prazosin according to hemodynamic response, in the prevention of esofagic verices rebleeding.

Detailed Description

The present is a prospective, randomized, open label study, in parallel groups, in which the patients with hemorrhage caused by esofagic varices will be randomized in two groups of treatment, after control of acute hemorrhage.

All the patients included will receive standard medical treatment with beta - blockers and endoscopic ligation of the esofagic varices.

The control group will be constituted by the patients assigned to receive endoscopic ligation and nadolol (N).

The experimental group will be constituted by patients assigned to receive treatment according to the hemodynamic response.

All patients included in the experimental group will receive pharmacologic treatment with nadolol combined with Isosorbide Mononitrate (MNI) or Prazosin (PZ).

In both groups it will practice a basal hepatic hemodynamic study in the 4th-5th day after their admitance (after achieve hemodynamic stability for at least 48 h and with hemorrhage controlled) and a second control hepatic hemodynamic study 3-4 weeks after the beginning of the pharmacologic treatment, once adjusted doses.

In the experimental group, the responders to N + MNI will keep on this treatment, but nonrespondent in the hemodynamic study will switch treatment to N + PZ and a third hepatic hemodynamic study will be performed 3 to 4 weeks after the dosage adjustement.

The randomization will be stratified according to the degree of hepatic failure measured by Child-Pugh classification (classes A and B versus C) The design is random to avoid bias in the selection of the patients.

Conditions

Gastrointestinal Hemorrhage; Portal Hypertension; Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

esofagic varices ligation

Intervention Type: PROCEDURE

Nadolol

Intervention Type: DRUG

Isosorbide mononitrate

Intervention Type: DRUG

Prazosin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Any Patient with endoscopically assessed Variceal Bleeding (esofagic and gastric)
• Cirrhosis
• Patient agreement to be included in the study onsentiment signed

Exclusion Criteria

• Any associated comorbidity with life expectancy lesser than 6 months
• Patient refusement to be included in the study.
• Pregnancy
• Failure to control acute bleeding
• Previous prophylaxis treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role: lead

Principal Investigators

Candid - Villanueva, Dr.

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Locations

Unidad de Sangrantes, HSCSP

Barcelona, Barcelona, Spain

Countries

Spain

Other Identifiers

KT-2000

Identifier Type: -

Identifier Source: org_study_id