Secondary Prophylaxis After Variceal Bleeding in Non-Responders
Secondary Prophylaxis After Variceal Bleeding in Non-Responders
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.
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.
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