- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01000779
Comparison of Endoscopic Variceal Ligation (EVL) With Propranolol in Non Cirrhotic Portal Hypertension (NCPH)
Comparison of Endoscopic Variceal Ligation (EVL) and Propranolol in Secondary Prophylaxis of Variceal Bleeding in Patients With Non Cirrhotic Portal Hypertension (NCPH): A Prospective Randomized Controlled Trial
Background: Variceal bleeding is a major cause of morbidity and mortality in patients with Non Cirrhotic Portal Hypertension (NCPH). Beta blockers (BB) and endoscopic variceal ligation (EVL) have been used to prevent rebleeding in these patients, largely based on data from cirrhotic patients. Endotherapy in the form of EST has been well studied in preventing rebleed in patients with NCPH. Initial studies showed that EST significantly reduced the rebleeding rate in patients of NCPH. Data from these studies suggests a rebleed rate of approximately 25% at 2yr and 35% at 5 years.
Beta blockers have been found to be quite effective in both primary as well as secondary prophylaxis of variceal bleeding in cirrhotic and are accepted mode of treatment. In contrast to liver cirrhosis, published data on the effect of beta blocker therapy on NCPH are scanty. Animal data and human data suggests that beta blockers reduce portal pressure in patients with NCPH. In two placebo controlled trials of propranolol on secondary prophylaxis of variceal bleeding in non cirrhotic patients. both studies demonstrated the efficacy of propranolol in decreasing rebleed rate. However, no comparisons hae been made with EVL till date.
Hypothesis: The investigators hypothesis that In patients with NCPH, treatment with beta blockers will lead to reduction in portal pressure and decrease in portosystemic shunting leading to reduction in variceal rebleeding Aim of the study: Aim: To compare the efficacy and safety of Propranolol and EVL in the prevention of variceal rebleeding in patients with NCPH.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Delhi
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New Delhi, Delhi, India, 110002
- Department of Gastroenterology, GB Pant Hospital,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with Non Cirrhotic Portal Hypertension (NCPH) presenting to our Liver Diseases Follow-up Clinic with history of hemetemesis and/or malena within the past 6 weeks and proven to have esophageal varices as the bleeding source on upper GI endoscopy
Exclusion Criteria:
- A history of surgery for portal hypertension
- Patients already on a EST, EVL, or glue injection program before presenting to our hospital
- Patients already on beta blockers for primary prophylaxis of variceal bleed
- Severe cardiopulmonary or renal disease
- Bradycardia (basal heart rate, <50 beats per minute [bpm]) or complete heart block
- A history of severe side effects or contraindications to β- blockers, like bronchial asthma, diabetes mellitus, heart failure, peripheral vascular disease, prostatic hypertrophy, or arterial hypotension (systolic blood pressure <90 mm Hg)
- Refusal to give informed written consent to participate in the trial
- Patients bleeding from gastric varices or Portal Hypertensive Gastropathy (PHG).
- Patients who had a failure of primary hemostasis during acute bleed were also excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Endoscopic Variceal Ligation
endoscopic therapy to obliterate varices
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to obliterate esophageal varices
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Active Comparator: Propranolol
drugs to decrease portal pressure
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upto 320mg/day maximum
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rebleed, death
Time Frame: At least 3 months after last enrollment
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At least 3 months after last enrollment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse effects of EVL or drug therapy, variceal eradication on EVL, variceal recurrence after eradication on EVL, decrease in variceal grade in the propranolol limb
Time Frame: At least 3 months after last enrollment
|
At least 3 months after last enrollment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shiv K Sarin, MD, DM, G.B. Pant Hospital, New Delhi, India
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Liver Diseases
- Hypertension
- Hypertension, Portal
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Propranolol
Other Study ID Numbers
- NG001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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