Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-04-16 @ 5:21 AM
Study NCT ID:
NCT01267669
Status:
COMPLETED
Last Update Posted:
2010-12-28
First Post:
2010-12-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Somatostatin With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013004', 'term': 'Somatostatin'}], 'ancestors': [{'id': 'D010905', 'term': 'Pituitary Hormone Release Inhibiting Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-27', 'studyFirstSubmitDate': '2010-12-27', 'studyFirstSubmitQcDate': '2010-12-27', 'lastUpdatePostDateStruct': {'date': '2010-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment failure', 'timeFrame': '5 days', 'description': 'The primary endpoint was treatment failure, defined as the occurrence of any of the following within a period of 120 h (5 days) from the time of admission: (i) Fresh hematemesis ≥2 hr after EVL; or (ii) Death within 5 days.'}], 'secondaryOutcomes': [{'measure': 'In-hospital mortality', 'timeFrame': 'During the same admission', 'description': 'Death during the same admission to the hospital'}, {'measure': 'Transfusion requirement', 'timeFrame': 'During hospital stay', 'description': 'Amount of packed cell or FFP infusions received during the hospital stay'}, {'measure': 'ICU stay in days', 'timeFrame': 'During the hospital stay', 'description': 'Number of dys the patient spent in ICU'}, {'measure': 'Drug-related adverse effects', 'timeFrame': '5 days', 'description': 'Adverse effects due to somatostatin or placebo infusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Variceal bleeding', 'Endoscopic therapy', 'Band ligation', 'Somatostatin', 'Vasoactive drugs', 'Octreotide'], 'conditions': ['Acute Bleeding Esophageal Varices', 'Portal Hypertension', 'Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '26628838', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Background: Efficacy of endoscopic variceal sclerotherapy in achieving initial control of acute variceal bleeding and five-day haemostasis has been shown to significantly improve when vasoactive drug is added. However, there is limited data whether addition of somatostatin, to endoscopic variceal ligation (EVL) improves the efficacy of EVL.\n\nAim: To compare EVL plus somatostatin versus EVL plus placebo in control of acute variceal bleeding.\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of portal hypertension\n* Having hematemesis and/or melena within 24 hour prior to admission\n* Source of bleeding should be esophageal varices\n\nExclusion Criteria:\n\n* Non-cirrhotic cause of portal hypertension\n* Age \\<12 or \\>75 years\n* Hepatic encephalopathy grade 3 or 4\n* Renal failure with serum creatinine \\>2 mg/dL\n* Any evidence of bleeding from additional source apart from esophageal varices (like gastric varices, portal hypertensive gastropathy, erosions or ulcers including variceal ulcers)\n* Patients already on vasoactive drugs like somatostatin or terlipressin during the current episode of bleeding\n* Patients already received EVL or EST elsewhere during the current episode of bleeding prior to presenting to our hospital\n* Patients with history of surgery for portal hypertension or TIPS\n* Concomitant severe cardio-pulmonary disease\n* Concomitant malignancy\n* HVPG not possible within 24 hrs of presentation\n* Patients refusing to participate in the study.'}, 'identificationModule': {'nctId': 'NCT01267669', 'acronym': 'AVB-EVL+S', 'briefTitle': 'A Trial of Somatostatin With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Govind Ballabh Pant Hospital'}, 'officialTitle': 'A Double Blind Randomized Placebo-Controlled Trial of Somatostatin in Association With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding', 'orgStudyIdInfo': {'id': '2005-PHT-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EVL plus Somatostatin', 'description': 'Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days', 'interventionNames': ['Drug: Somatostatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'EVL plus Placebo', 'description': 'Emergency EVL plus placebo infusion for 5 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Somatostatin', 'type': 'DRUG', 'otherNames': ['Somatosan', 'Somastin'], 'description': 'Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days', 'armGroupLabels': ['EVL plus Somatostatin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Emergency EVL plus placebo infusion for 5 days', 'armGroupLabels': ['EVL plus Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110 002', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Department of Gastroenterology, G B Pant Hospital', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'overallOfficials': [{'name': 'Shiv K Sarin, MD, DM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'G B Pant Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Govind Ballabh Pant Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr S K Sarin', 'oldOrganization': 'Department of Gastroenterology, G B Pant Hospital, New Delhi, India'}}}}