Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT01538368
Status:
COMPLETED
Last Update Posted:
2012-02-24
First Post:
2012-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance Cholangio-pancreatography (MRCP) for Suspected Bilio-pancreatic Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-23', 'studyFirstSubmitDate': '2012-02-20', 'studyFirstSubmitQcDate': '2012-02-23', 'lastUpdatePostDateStruct': {'date': '2012-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endoscopic management', 'timeFrame': '1 day', 'description': 'Did the MRCP-interpretation by the gastroenterologist alter the scheduled endoscopic interventions ?'}], 'secondaryOutcomes': [{'measure': 'MRCP-interpretation', 'timeFrame': '1 day', 'description': 'Are there differences in the MRCP-interpreatation beween the radiologist and the gastroenterologist.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MRCP', 'ERCP', 'EUS', 'Image interpretation', 'MRCP findings', 'endoscopic intervention(s)'], 'conditions': ['Suspected Bilio-pancreatic Disease']}, 'descriptionModule': {'briefSummary': 'The interpretation of Magnetic Resonance Cholangio-pancreatography (MRCP)-findings is primarily performed by radiologists who only in some cases have experience with the interpretation of endoscopic retrograde cholangiopancreatography (ERCP)-images. It is unclear if MRCP-interpretation by the radiologist is sufficient to decide which additional endoscopic procedures might be necessary in an individual case or if an additional MRCP-interpretation by the endoscopist renders any clinical impact.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'During 1/2007 until 12/2009 consecutive patients who were referred for dedicated endoscopic procedures regarding suspected alterations of the pancreato-biliary ductal system (nearly exclusively for EUS and/or ERCP) to our unit based on actual MRCP-findings were enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or older who were referred for pancreato-biliary endoscopy to our unit based on actual MRCP-findings. In all cases MRCP should have been performed within 4 weeks prior admittance and a written radiological report as well as the digital images must be available.\n\nExclusion Criteria:\n\n* Patients who had any endoscopic interventions in our institution before and also patients who underwent MRCP at our hospital were excluded.'}, 'identificationModule': {'nctId': 'NCT01538368', 'briefTitle': 'Magnetic Resonance Cholangio-pancreatography (MRCP) for Suspected Bilio-pancreatic Disease', 'organization': {'class': 'OTHER', 'fullName': 'Deutsche Klinik fuer Diagnostik'}, 'officialTitle': 'Magnetic Resonance Cholangio-pancreatography (MRCP) for Suspected Bilio-pancreatic Disease: Should the Endoscopist Take a Second Look?', 'orgStudyIdInfo': {'id': 'TWehrmann'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deutsche Klinik fuer Diagnostik', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Divison of Gastroenterology, DKD Wiesbaden', 'investigatorFullName': 'Till Wehrmann', 'investigatorAffiliation': 'Deutsche Klinik fuer Diagnostik'}}}}