Secondary Prophylaxis After Variceal Bleeding in Non-Responders

Condition(s) targeted: Gastrointestinal Hemorrhage; Portal Hypertension; Cirrhosis

Intervention: esofagic varices ligation (Procedure); Nadolol (Drug); Isosorbide mononitrate (Drug); Prazosin (Drug)

Phase: Phase 4

Status: Completed

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: Fundació 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)

Secondary outcome:

Mortallity

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.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Unidad de Sangrantes, HSCSP, Barcelona 08025, Spain

Starting date: November 2000
Ending date: June 2004
Last updated: March 20, 2007