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

Not Applicable

Completed

• Conditions: Portal Hypertension
• Interventions: Drug: EVL + Propranolol + Isosorbide 5 mononitrate; Other: EVL alone

• Registration Number: NCT00766805
• Lead Sponsor: Govind Ballabh Pant Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2006-12
• Study Completion: 2007-06
• Status Verified: 2008-10
• Study First Submitted: 2008-10-03
• Study First Submitted QC: 2008-10-03
• Last Update Submitted: 2008-10-03
• Study First Posted: 2008-10-06
• Last Update Posted: 2008-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EVL + Drugs	EVL + Propranolol + Isosorbide 5 mononitrate	Patients randomized to the EVL plus drugs therapy received EVL plus beta-blocker (propranolol) and nitrate (ISMN).
EVL alone	EVL alone	Patients assigned to the EVL group underwent variceal band ligation alone till variceal obliteration.

Primary Outcome Measures

Name	Time	Method
Primary end points of the study were bleeding and death.	During the study period

Secondary Outcome Measures

Name	Time	Method
Complications, UGI bleeding due to causes not related to PHT, and adverse effects that required the discontinuation of therapy.	During the study period

Trial Locations

Locations (1)

Department of Gastroenterology, G B Pant Hospital; 🇮🇳 New Delhi, Delhi, India