Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-31 @ 2:07 PM
Study NCT ID:
NCT01080833
Status:
COMPLETED
Last Update Posted:
2010-03-19
First Post:
2010-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of ERCP Mechanical Simulator (EMS) Practice on Endoscopic Retrograde Cholangiopancreatography (ERCP) Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-18', 'studyFirstSubmitDate': '2010-03-01', 'studyFirstSubmitQcDate': '2010-03-03', 'lastUpdatePostDateStruct': {'date': '2010-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic biliary cannulation and deep biliary cannulation success rates', 'timeFrame': '12 months', 'description': 'The ability of the trainees to perform solo diagnostic biliary cannulation and deep biliary cannulation'}], 'secondaryOutcomes': [{'measure': 'Trainer assessment', 'timeFrame': '12 months', 'description': 'Subjective competency (5-point score) graded by supervising physicians.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['EMS', 'ERCP', 'Training', 'Trainees'], 'conditions': ['Training']}, 'referencesModule': {'references': [{'pmid': '17531642', 'type': 'BACKGROUND', 'citation': 'Leung JW, Lee JG, Rojany M, Wilson R, Leung FW. Development of a novel ERCP mechanical simulator. Gastrointest Endosc. 2007 Jun;65(7):1056-62. doi: 10.1016/j.gie.2006.11.018.'}]}, 'descriptionModule': {'briefSummary': 'Trainees who are offered ERCP Mechanical Simulator (EMS) training in addition to routine training (study group) will demonstrate improved clinical outcomes compared to those undergoing routine ERCP training only (control group).', 'detailedDescription': "Hypothesis #1: Trainees who are offered simulator training in addition to routine training (study group) will demonstrate improved clinical outcomes compared to those undergoing routine ERCP training only (control group).\n\nHypothesis #2: Trainees who are initially in the control arm, but receive the simulator training after the initial 30 procedures (delayed intervention) will have significantly greater improvement of clinical outcomes in the second phase of the study (steeper learning curve) compared to the initial period.\n\nSTUDY DESIGN \\& OUTCOMES\n\n* Controlled randomized observational study.\n* Immediate intervention (simulator training in the beginning of or just prior to the trainees' ERCP rotation) and delayed intervention (simulator training after 30 clinical procedures) will be studied\n* Primary outcome: diagnostic biliary cannulation and deep biliary cannulation success rates Secondary outcomes: cannulation time, subjective competency score (5-point scale) graded by supervising physicians."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gastrointestinal fellows receiving ERCP training\n\nExclusion Criteria:\n\n* Gastrointestinal fellows who are not receiving ERCP training'}, 'identificationModule': {'nctId': 'NCT01080833', 'acronym': 'ERCP', 'briefTitle': 'Effect of ERCP Mechanical Simulator (EMS) Practice on Endoscopic Retrograde Cholangiopancreatography (ERCP) Training', 'organization': {'class': 'OTHER', 'fullName': 'East Bay Institute for Research and Education'}, 'officialTitle': "Effect of Simulator Practice on Trainees' ERCP (Endoscopic Retrograde Cholangiopancreatography) Performance in the Early Learning Period: a Multi-center Randomized Controlled Observational Study", 'orgStudyIdInfo': {'id': 'EBIRE-GI-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ERCP mechanical simulator practice', 'description': 'Trainees who are offered ERCP Mechanical Simulator (EMS) training in addition to routine training (study group)', 'interventionNames': ['Device: ERCP mechanical simulator practice']}, {'type': 'NO_INTERVENTION', 'label': 'No ERCP mechanical simulator practice', 'description': 'Trainees undergoing routine ERCP training only (control group).'}], 'interventions': [{'name': 'ERCP mechanical simulator practice', 'type': 'DEVICE', 'description': 'Trainees will receive ERCP mechanical simulator practice in addition to routine ERCP training', 'armGroupLabels': ['ERCP mechanical simulator practice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Joseph W Leung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sacramento VA Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'East Bay Institute for Research and Education', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, Davis', 'class': 'OTHER'}, {'name': 'University of California, Irvine', 'class': 'OTHER'}, {'name': 'University of Arizona', 'class': 'OTHER'}, {'name': 'Phoenix VA Health Care System', 'class': 'FED'}, {'name': 'University of New Mexico', 'class': 'OTHER'}, {'name': 'United States Naval Medical Center, San Diego', 'class': 'FED'}, {'name': 'Kaiser Permanente', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Joseph Leung, MD', 'oldOrganization': 'EBIRE'}}}}