Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 1:37 AM
Study NCT ID:
NCT06310460
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of "PreCut-Papillectomy" in Difficult Biliary Cannulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-07', 'studyFirstSubmitDate': '2024-03-07', 'studyFirstSubmitQcDate': '2024-03-07', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of treatment success', 'timeFrame': 'During endoscopy', 'description': 'Rate of successful cannulation of the bile duct after PreCut-papillectomy'}, {'measure': 'Adverse event rate', 'timeFrame': 'Up to 30 days', 'description': 'Rate of adverse events, as classifed by ASGE classification'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cholangiopancreatography, Endoscopic Retrograde']}, 'descriptionModule': {'briefSummary': 'To evaluate the effectiveness and sefety of papillectomy to enable bile duct access during endoscopic retrograde cholangiography in patients with difficult biliary cannulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing ERCP with intented bile duct cannulation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Difficult cannulation of bile duct\n\nExclusion Criteria:\n\n* post-surgical upper GI anatomy\n* previous endoscopic retrograde cholangiopancreaticography or percutaneous transhepatic cholangiography\n* papilla within a diverticulum\n* coagulation disorder'}, 'identificationModule': {'nctId': 'NCT06310460', 'briefTitle': 'Evaluation of "PreCut-Papillectomy" in Difficult Biliary Cannulation', 'organization': {'class': 'OTHER', 'fullName': 'Kliniken Ludwigsburg-Bietigheim gGmbH'}, 'officialTitle': 'Prospective Monocentric Cohort Study to Evluate Pre-cut Papillectomy in Patients With Difficult Biliary Cannulation During Endoscopic Retrograde Cholangiopancreaticography', 'orgStudyIdInfo': {'id': 'PCP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Papillectomy', 'type': 'PROCEDURE', 'description': 'Papillectomy prior to bile duct cannulation during ERCP'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Andreas Wannhoff, Dr.', 'role': 'CONTACT', 'email': 'Andreas.Wannhoff@rkh-gesundheit.de', 'phone': '+49-7141-67204'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kliniken Ludwigsburg-Bietigheim gGmbH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}