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Completed

NCT Number: NCT00766805

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

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.

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Key information

Conditions

Portal Hypertension Digestive System Diseases Hypertension, Portal Liver Diseases

Age range

8 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterology, G B Pant Hospital

New Delhi, National Capital Territory of Delhi, 110002, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EVL + Propranolol + Isosorbide 5 mononitrate

Drug

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.

EVL alone

Other

Primary outcomes

  1. Primary end points of the study were bleeding and death.

    Time frame: During the study period

Secondary outcomes

  1. Complications, UGI bleeding due to causes not related to PHT, and adverse effects that required the discontinuation of therapy.

    Time frame: During the study period

Sponsors and collaborators

Lead sponsor

Govind Ballabh Pant Hospital

Other Gov

Registry information

Official study title

Endoscopic Variceal Ligation Plus Propranolol And Isosorbide Mononitrate Versus Endoscopic Variceal Ligation Alone For Secondary Prophylaxis Of Variceal Bleeding: A Randomized Controlled Trial

Acronym: Secondary

Important dates

Study start
2002
Primary completion
2006
Study completion
2007
First posted
Oct 6, 2008
Registry last updated
Oct 6, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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