Endoscopic Variceal Ligation (EVL)+ Drugs Versus Endoscopic Variceal Ligation (EVL) Alone For Secondary Prophylaxis
Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
Summary
Background: Both endoscopic variceal ligation (EVL) and propranolol are valuable methods for
secondary prophylaxis of variceal bleeding. Addition of ISMN to propranolol improves the
efficacy of drug therapy. It is hypothesized that a combination of EVL and portal pressure
reducing drugs should significantly be better than EVL alone.
Patients and Methods: Patients with history of variceal bleed were randomized to EVL plus
drugs (propranolol and ISMN) or EVL alone. EVL was repeated every 3-4 weeks until variceal
eradication. Propranolol dose was adjusted to reduce the resting heart rate to 55 bpm. Dose
of ISMN was 40 mg/d. Primary end points were rebleed or death. Secondary end points included
complications of portal hypertension and the development of serious adverse effects to
therapy.