Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT00124202
Status:
COMPLETED
Last Update Posted:
2013-07-31
First Post:
2005-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of a Fatty Meal on Endoscopic Retrograde Cholangiopancreatography (ERCP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-29', 'studyFirstSubmitDate': '2005-07-25', 'studyFirstSubmitQcDate': '2005-07-25', 'lastUpdatePostDateStruct': {'date': '2013-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'a fatty meal in the study group and normal saline in control group', 'timeFrame': 'the procedure time for ERCP'}], 'secondaryOutcomes': [{'measure': 'follow up within 3 days for complication with relation to the cannulation time', 'timeFrame': 'within 3 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['a fatty meal', 'ERCP'], 'conditions': ['Biliary Tract Disease']}, 'descriptionModule': {'briefSummary': 'This study is to determine if a fatty meal would improve the ERCP procedure.', 'detailedDescription': 'A fatty meal is a potent stimulator of cholecystikinin (CCK) in human body. The biological effect of CCK is increasing bile secretion and relaxing the sphincter of Oddi. Theoretically, a fatty meal should facilitate the effect on cannulation at ERCP. If a fatty meal can make the major papilla cannulation easier, it may significantly shorten the procedure time for ERCP and even decrease complications of the procedure, since the complication rate of post-ERCP is positively related to the time of the procedure.\n\nComparison: Approximately one hour before ERCP procedure, patient will have a fatty meal in the study group and normal saline in control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients, 18 years and older, who are scheduled for ERCP at Emory University Hospital and signed consent before the procedure.\n\nExclusion Criteria:\n\n* Patients with a known allergy to milk or those who choose not to sign the consent.'}, 'identificationModule': {'nctId': 'NCT00124202', 'briefTitle': 'Effect of a Fatty Meal on Endoscopic Retrograde Cholangiopancreatography (ERCP)', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Effect of a Fatty Meal on Cannulation at Endoscopic Retrograde Cholangiopancreatography', 'orgStudyIdInfo': {'id': '229-2003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'a fatty meal vs normal saline', 'description': 'Approximately one hour before ERCP procedure, patient will have a fatty meal in the study group and normal saline in control group', 'interventionNames': ['Behavioral: a fatty meal']}], 'interventions': [{'name': 'a fatty meal', 'type': 'BEHAVIORAL', 'description': 'Approximately one hour before ERCP procedure, patient will have a fatty meal in the study group and normal saline in control group', 'armGroupLabels': ['a fatty meal vs normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine; Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Qiang Cai, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr. Qiang Cai MD/PhD', 'investigatorAffiliation': 'Emory University'}}}}