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

Govind Ballabh Pant Hospital

Status: Completed

Conditions: Portal Hypertension

Treatments: Drug: EVL + Propranolol + Isosorbide 5 mononitrate; Other: EVL alone

Study type: Interventional

Funder types: Other

Identifiers

NCT00766805

2008-PHT-01

Details and patient eligibility

About

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.

Enrollment: 177 patients

Sex: All

Ages: 8 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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177 participants in 2 patient groups, including a placebo group

EVL + Drugs

Active Comparator group

Description:

Patients randomized to the EVL plus drugs therapy received EVL plus beta-blocker (propranolol) and nitrate (ISMN).

Treatment:

Drug: EVL + Propranolol + Isosorbide 5 mononitrate

EVL alone

Placebo Comparator group

Description:

Patients assigned to the EVL group underwent variceal band ligation alone till variceal obliteration.

Treatment:

Other: EVL alone