Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 11:13 AM
Study NCT ID:
NCT07490132
Status:
RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Retrograde Cholangiopancreatography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '25 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-18', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Underwent ERCP', 'timeFrame': '25 years', 'description': 'Patients undergoing ERCPs at Methodist Dallas Medical Center.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastro-Intestinal Disorder']}, 'descriptionModule': {'briefSummary': 'The risk of post-endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis(PEP) is influenced by patient and procedure-related factors. Strategies to decrease PEP(Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis) are of great importance.', 'detailedDescription': 'The primary objective of this study is to provide a mechanism to store the following information about patients undergoing ERCPs at Methodist Dallas Medical Center. This registry will be permissive of quality improvement and research studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent ERCP and in MDI(Methodist Digestive Institute) registry.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients \\>15 years Included in MDI's Registry Underwent ERCP between January 1, 2000 through December 31, 2025\n\nExclusion Criteria:\n\nPatients \\<15 years Patients in which cannulation was via a surgical anastomosis Patients in which cannulation was not attempted due to gastric outlet obstruction, the main papilla not found, or the minor papilla was not found will be excluded."}, 'identificationModule': {'nctId': 'NCT07490132', 'briefTitle': 'Endoscopic Retrograde Cholangiopancreatography', 'organization': {'class': 'OTHER', 'fullName': 'Methodist Health System'}, 'officialTitle': 'Endoscopic Retrograde Cholangiopancreatography Patient Registry', 'orgStudyIdInfo': {'id': '046.GID.2024.D'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Underwent ERCP', 'description': 'Underwent ERCP between January 1, 2000 through December 31, 2025', 'interventionNames': ['Other: Patients undergoing ERCPs at Methodist Dallas Medical Center']}], 'interventions': [{'name': 'Patients undergoing ERCPs at Methodist Dallas Medical Center', 'type': 'OTHER', 'description': 'The registry will include all patients who meet registry inclusion. Enrollment will terminate once 25 years of data are captured: January 1, 2000 through December 31, 2025.', 'armGroupLabels': ['Underwent ERCP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75203', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Colette Ngo Ndjom', 'role': 'CONTACT', 'email': 'ClinicalResearch@mhd.com', 'phone': '214-947-1289'}, {'name': 'Kavya Mankulangara', 'role': 'CONTACT', 'email': 'ClinicalResearch@mhd.com', 'phone': '214-947-4604'}], 'facility': 'Methodist Dallas Medical Center- Clinical Research Institute', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Crystee Cooper, DHEd', 'role': 'CONTACT', 'email': 'ClinicalResearch@mhd.com', 'phone': '214-947-1280'}, {'name': 'Kavya Mankulangara', 'role': 'CONTACT', 'email': 'ClinicalResearch@mhd.com', 'phone': '214-947-4604'}], 'overallOfficials': [{'name': 'Prashant Kedia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Methodist Health System'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'The investigator will make all possible efforts to ensure compliance with all policies regarding sharing of Protected Health Information or research information. Only de-identified Protected Health Information will be shared in relevant research mediums.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Methodist Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}