Secondary Prophylaxis After Variceal Bleeding in Non-Responders
Information source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastrointestinal Hemorrhage; Portal Hypertension; Cirrhosis
Intervention: esofagic varices ligation (Procedure); Nadolol (Drug); Isosorbide mononitrate (Drug); Prazosin (Drug)
Phase: Phase 4
Sponsored by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official(s) and/or principal investigator(s):
Candid - Villanueva, Dr., Principal Investigator, Affiliation: FundaciĆ³ Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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.
Official title: Secondary Prophylaxis After Variceal Bleeding: Combined Treatment With Endoscopic Ligation and Nadolol Against Nadolol Associated With Mononitrate of Isosorbide or Prazosin According to Hemodynamic Response.
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Compared efficacy (at least 6 moths of follow-up)
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.
Minimum age: 18 Years.
Maximum age: 80 Years.
- Any Patient with endoscopically assessed Variceal Bleeding (esofagic and gastric)
- Patient agreement to be included in the study onsentiment signed
- Any associated comorbidity with life expectancy lesser than 6 months
- Patient refusement to be included in the study.
- Failure to control acute bleeding
- Previous prophylaxis treatment
Locations and Contacts
Unidad de Sangrantes, HSCSP, Barcelona 08025, Spain
Starting date: November 2000
Ending date: June 2004
Last updated: March 20, 2007