Endoscopic Variceal Ligation (EVL)+ Drugs Versus Endoscopic Variceal Ligation (EVL) Alone For Secondary Prophylaxis - Full Text View

Sponsored by:	Govind Ballabh Pant Hospital
Information provided by:	Govind Ballabh Pant Hospital
ClinicalTrials.gov Identifier:	NCT00766805

Purpose

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.

Condition	Intervention
Portal Hypertension	Drug: EVL + Propranolol + Isosorbide 5 mononitrate Other: EVL alone

MedlinePlus related topics: Endoscopy High Blood Pressure

Drug Information available for: Propranolol Dexpropranolol Propranolol hydrochloride Isosorbide Isosorbide dinitrate Isosorbide-5-mononitrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Endoscopic Variceal Ligation Plus Propranolol And Isosorbide Mononitrate Versus Endoscopic Variceal Ligation Alone For Secondary Prophylaxis Of Variceal Bleeding: A Randomized Controlled Trial

Further study details as provided by Govind Ballabh Pant Hospital:

Primary Outcome Measures:

Primary end points of the study were bleeding and death. [ Time Frame: During the study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Enrollment:	177
Study Start Date:	October 2002
Study Completion Date:	June 2007
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
EVL + Drugs: Active Comparator Patients randomized to the EVL plus drugs therapy received EVL plus beta-blocker (propranolol) and nitrate (ISMN).	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.
EVL alone: Placebo Comparator Patients assigned to the EVL group underwent variceal band ligation alone till variceal obliteration.	Other: EVL alone

Arms

Assigned Interventions

EVL + Drugs: Active Comparator

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

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.

EVL alone: Placebo Comparator

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

Other: EVL alone

Eligibility

Ages Eligible for Study:	8 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766805

Locations

India, Delhi
Department of Gastroenterology, G B Pant Hospital
New Delhi, Delhi, India, 110002

Sponsors and Collaborators

Govind Ballabh Pant Hospital

More Information

Responsible Party:	Department of Gastroenterology, G B Pant Hospital, New Delhi, India ( Dr S K Sarin )
Study ID Numbers:	2008-PHT-01
Study First Received:	October 3, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00766805
Health Authority:	India: Ministry of Health

Study placed in the following topic categories:

Isosorbide
Liver Diseases
Isosorbide-5-mononitrate
Vascular Diseases
Isosorbide Dinitrate
Hypertension, Portal
Hemorrhage

Portal hypertension
Nitric Oxide
Digestive System Diseases
Propranolol
Neoplasm Metastasis
Hypertension

Additional relevant MeSH terms:

Neurotransmitter Agents
Vasodilator Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Diuretics, Osmotic
Diuretics
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Nitric Oxide Donors
Natriuretic Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on January 16, 2009