Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-03-05 @ 11:31 AM
Study NCT ID:
NCT00222092
Status:
COMPLETED
Last Update Posted:
2011-08-24
First Post:
2005-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Somatostatin, Octreotide, Pentoxyfilline in the Prevention of Post-ERCP Pancreatitis and Molecular Markers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2006-09'}, 'lastUpdateSubmitDate': '2011-08-23', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2011-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['post-ERCP pancreatitis', 'prophylaxis', 'prognosis', 'natural course', 'molecular markers'], 'conditions': ['Post-ERCP Acute Pancreatitis']}, 'descriptionModule': {'briefSummary': 'Octreotide, somatostatin and pentoxyfilline commercially available drugs that are used in various clinical situations. They are safe and known for years. Octreotide and somatostatin have been used in many studies for the prophylaxis and treatment of pancreatitis and post-ERCP pancreatitis, while pentoxyfilline has shown effect on patients with alcoholic hepatitis, obstructive vasculitis etc. The aim of the study is to evaluate the efficacy of any of those treatments for the prophylaxis and treatment of post-ERCP pancreatitis. In addition some molecular markers of acute and chronic inflammation will be measured before and after the endoscopic procedures according to the study protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing endoscopic retrograde cholangiopancreatography', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing endoscopic retrograde cholangiopancreatography\n\nExclusion Criteria:\n\n* children, pregnant or breastfeeding women\n* patients with coagulation disorders\n* inability to access the papilla of Vater due to technical difficulties (previous surgery, malignant obstruction)'}, 'identificationModule': {'nctId': 'NCT00222092', 'briefTitle': 'Somatostatin, Octreotide, Pentoxyfilline in the Prevention of Post-ERCP Pancreatitis and Molecular Markers', 'organization': {'class': 'OTHER', 'fullName': 'University of Ioannina'}, 'officialTitle': 'Effect of Octreotide, Somatostatin, Pentoxyfilline or Placebo in the Prevention and the Course of Post-ERCP Pancreatitis and Study of Molecular Markers in Post-ERCP Pancreatitis', 'orgStudyIdInfo': {'id': 'SIG-2005'}}, 'contactsLocationsModule': {'locations': [{'zip': '45110', 'city': 'Ioannina', 'country': 'Greece', 'facility': 'Hepato-Gastroenterology Unit, Medical School of Ioannina - Greece', 'geoPoint': {'lat': 39.66341, 'lon': 20.85187}}], 'overallOfficials': [{'name': 'Dimitrios Sigounas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ioannina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ioannina', 'class': 'OTHER'}}}}