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

NCT00766805 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2008-10-06

No results posted yet for this study

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.

Conditions

  • Portal Hypertension

Interventions

DRUG

EVL + Propranolol + Isosorbide 5 mononitrate

Treatment was started with propranolol at a dose of 40 mg twice a day. The heart rate and blood pressure were checked after 12 to 24 hours. The dose of propranolol was increased at increments of 20 to 40 mg per day until the patient achieved a heart rate of 55 bpm, or a maximum dose of 320 mg/day was achieved.ISMN was added at a dose of 10 mg twice a day. The dose was escalated at increments of 10-20 mg/day till a maximum dose of 40 mg/day was reached.

OTHER

EVL alone

Sponsors & Collaborators

  • Govind Ballabh Pant Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2006-12-31
Completion
2007-06-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00766805 on ClinicalTrials.gov