A Trial of Somatostatin With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding
NCT ID: NCT01267669
Last Updated: 2010-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2005-11-30
2009-11-30
Brief Summary
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Aim: To compare EVL plus somatostatin versus EVL plus placebo in control of acute variceal bleeding.
Patients and methods: Consecutive cirrhotic patients with acute variceal bleeding from esophageal varices were enrolled in the trial. After emergency EVL, patients were randomized to receive either somatostatin (250 mcg/hr) or placebo infusion. Primary endpoint was treatment failure within 5 days. Treatment failure was defined as fresh hematemesis ≥2 hour after start of therapy or death.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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EVL plus Somatostatin
Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days
Somatostatin
Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days
EVL plus Placebo
Emergency EVL plus placebo infusion for 5 days
Placebo
Emergency EVL plus placebo infusion for 5 days
Interventions
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Somatostatin
Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days
Placebo
Emergency EVL plus placebo infusion for 5 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Having hematemesis and/or melena within 24 hour prior to admission
* Source of bleeding should be esophageal varices
Exclusion Criteria
* Age \<12 or \>75 years
* Hepatic encephalopathy grade 3 or 4
* Renal failure with serum creatinine \>2 mg/dL
* Any evidence of bleeding from additional source apart from esophageal varices (like gastric varices, portal hypertensive gastropathy, erosions or ulcers including variceal ulcers)
* Patients already on vasoactive drugs like somatostatin or terlipressin during the current episode of bleeding
* Patients already received EVL or EST elsewhere during the current episode of bleeding prior to presenting to our hospital
* Patients with history of surgery for portal hypertension or TIPS
* Concomitant severe cardio-pulmonary disease
* Concomitant malignancy
* HVPG not possible within 24 hrs of presentation
* Patients refusing to participate in the study.
12 Years
75 Years
ALL
No
Sponsors
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Govind Ballabh Pant Hospital
OTHER_GOV
Responsible Party
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Department of Gastroenterology, G B Pant Hospital, New Delhi, India
Principal Investigators
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Shiv K Sarin, MD, DM
Role: PRINCIPAL_INVESTIGATOR
G B Pant Hospital
Locations
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Department of Gastroenterology, G B Pant Hospital
New Delhi, National Capital Territory of Delhi, India
Countries
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References
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Kumar A, Jha SK, Mittal VV, Sharma P, Sharma BC, Sarin SK. Addition of Somatostatin After Successful Endoscopic Variceal Ligation Does not Prevent Early Rebleeding in Comparison to Placebo: A Double Blind Randomized Controlled Trial. J Clin Exp Hepatol. 2015 Sep;5(3):204-12. doi: 10.1016/j.jceh.2015.06.001. Epub 2015 Jun 16.
Other Identifiers
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2005-PHT-01
Identifier Type: -
Identifier Source: org_study_id