Secondary Prophylaxis After Variceal Bleeding in Non-Responders

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Gastrointestinal Hemorrhage, Portal Hypertension, Cirrhosis

Intervention / Treatment
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* Procedure: esofagic varices ligation
* Drug: Nadolol
* Drug: Isosorbide mononitrate
* Drug: Prazosin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: esofagic varices ligation|nan|
|Drug: Nadolol|nan|
|Drug: Isosorbide mononitrate|nan|
|Drug: Prazosin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compared efficacy (at least 6 moths of follow-up) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortallity |  |  | 
| Rebleeding |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Variceal bleeding, Secondary profilaxis, Hemodynamic, Portal hypertension