Endoscopic Variceal Ligation (EVL)+ Drugs Versus Endoscopic Variceal Ligation (EVL) Alone For Secondary Prophylaxis

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Govind Ballabh Pant Hospital
• Treatments: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate; Propranolol

Criteria

Inclusion Criteria:

• Patients presenting to G B Pant Hospital, New Delhi, with history of hematemesis and/or melena and proven to have esophageal varices as the bleeding source on upper GI endoscopy were included in the study.

Exclusion Criteria:

• A history of undergoing endoscopic sclerotherapy (EST), EVL, or cyanoacrylate injection;

• A history of surgery for portal hypertension;

• Coexisting malignancy;

• Severe cardiopulmonary or renal disease;

• A history of severe side-effects or contraindications to beta-blockers like bronchial asthma, uncontrolled diabetes mellitus, heart failure, peripheral vascular disease, prostatic hypertrophy, arterial hypotension (systolic blood pressure < 100 mm Hg), bradycardia (basal heart rate <55 beats per minute), or complete heart block; and

• Refusal to give consent to participate in the trial.