Secondary Prophylaxis After Variceal Bleeding in Non-Responders (KT-2000)
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.
Procedure: esofagic varices ligation
Drug: Isosorbide mononitrate
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|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.|
- Compared efficacy (at least 6 moths of follow-up)
|Study Start Date:||November 2000|
|Study Completion Date:||June 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450164
|Unidad de Sangrantes, HSCSP|
|Barcelona, Spain, 08025|
|Principal Investigator:||Candid - Villanueva, Dr.||Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau|