Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT04052633
Status:
COMPLETED
Last Update Posted:
2019-08-12
First Post:
2019-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Success of Intraoperative Cholangiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D042883', 'term': 'Choledocholithiasis'}], 'ancestors': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D003137', 'term': 'Common Bile Duct Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-07', 'studyFirstSubmitDate': '2019-03-30', 'studyFirstSubmitQcDate': '2019-08-07', 'lastUpdatePostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of intraoperative cholangiography', 'timeFrame': '6 months', 'description': 'number of successful cannulation'}], 'secondaryOutcomes': [{'measure': 'technical success of intraoperative cholangiography', 'timeFrame': '6 months', 'description': 'grades of technical success ( easy, , minimal difficulties, major difficulties)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['c arm cholangiography', 'cholecystectomy'], 'conditions': ['Cholecystolithiasis', 'Choledocholithiasis']}, 'referencesModule': {'references': [{'pmid': '18392894', 'type': 'BACKGROUND', 'citation': 'Nassar AH, El Shallaly G, Hamouda AH. Optimising laparoscopic cholangiography time using a simple cannulation technique. Surg Endosc. 2009 Mar;23(3):513-7. doi: 10.1007/s00464-008-9853-8. Epub 2008 Apr 4.'}, {'pmid': '17285384', 'type': 'BACKGROUND', 'citation': 'Hamouda AH, Goh W, Mahmud S, Khan M, Nassar AH. Intraoperative cholangiography facilitates simple transcystic clearance of ductal stones in units without expertise for laparoscopic bile duct surgery. Surg Endosc. 2007 Jun;21(6):955-9. doi: 10.1007/s00464-006-9127-2. Epub 2007 Feb 7.'}, {'pmid': '19118424', 'type': 'BACKGROUND', 'citation': 'Karthikesalingam A, Markar SR, Weerakkody R, Walsh SR, Carroll N, Praseedom RK. Radiation exposure during laparoscopic cholecystectomy with routine intraoperative cholangiography. Surg Endosc. 2009 Aug;23(8):1845-8. doi: 10.1007/s00464-008-0279-0. Epub 2009 Jan 1.'}, {'pmid': '26585194', 'type': 'BACKGROUND', 'citation': 'Jolley J, Lomelin D, Simorov A, Tadaki C, Oleynikov D. Resident involvement in laparoscopic procedures does not worsen clinical outcomes but may increase operative times and length of hospital stay. Surg Endosc. 2016 Sep;30(9):3783-91. doi: 10.1007/s00464-015-4674-z. Epub 2015 Nov 19.'}, {'pmid': '22183717', 'type': 'BACKGROUND', 'citation': 'Ford JA, Soop M, Du J, Loveday BP, Rodgers M. Systematic review of intraoperative cholangiography in cholecystectomy. Br J Surg. 2012 Feb;99(2):160-7. doi: 10.1002/bjs.7809. Epub 2011 Dec 19.'}, {'pmid': '20706739', 'type': 'BACKGROUND', 'citation': 'Overby DW, Apelgren KN, Richardson W, Fanelli R; Society of American Gastrointestinal and Endoscopic Surgeons. SAGES guidelines for the clinical application of laparoscopic biliary tract surgery. Surg Endosc. 2010 Oct;24(10):2368-86. doi: 10.1007/s00464-010-1268-7. Epub 2010 Aug 13. No abstract available.'}, {'pmid': '29953458', 'type': 'RESULT', 'citation': 'Iranmanesh P, Tobler O, De Sousa S, Andres A, Frossard JL, Morel P, Toso C. Feasibility, benefit and risk of systematic intraoperative cholangiogram in patients undergoing emergency cholecystectomy. PLoS One. 2018 Jun 28;13(6):e0199147. doi: 10.1371/journal.pone.0199147. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the present study was to evaluate the success of routine use of intraoperative cholangiography (IOC ) and to examine the factors that are hindering the performance of intraoperative c-arm cholangiography.', 'detailedDescription': 'From January 2018 to August 2018 all consecutive elective and emergency cholecystectomies performed were entered in a prospective database. IOC has been instructed to be performed routinely when feasible during cholecystectomy since 1998. All elective operations were performed either by residents or specialist surgeons. For this study the investigators collected the radiation exposure values from exposure and pulsed fluoroscopy. Fluoroscopy time (s) was recorded.The operating surgeon was asked to fulfill a questionnaire directly after the cholecystectomy. The technical success and reasons for possible deferral of IOC were documented.Patient data from unsuccessful or deferred cholangiography cases was checked 6 months after cholecystectomy for possible symptomatic residual choledocholithiasis.Laparoscopic cholecystectomies were performed both by residents and specialist surgeons.\n\nEthics: The study was approved by the hospital administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all consecutive cholecystectomy patients during January 2018 to August 2018 which are operated with open or laparoscopic cholecystectomy for symptomatic cholelithiasis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all consecutive cholecystectomy patients during January 2018 to August 2018\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04052633', 'briefTitle': 'Success of Intraoperative Cholangiography', 'organization': {'class': 'OTHER', 'fullName': 'Jyväskylä Central Hospital'}, 'officialTitle': 'Success of Routine Intraoperative Cholangiography', 'orgStudyIdInfo': {'id': 'IOC1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cholangiography success', 'description': 'From January 2018 to August 2018 all consecutive elective and emergency cholecystectomies performed with intraoperative success of cholangiography', 'interventionNames': ['Radiation: intraoperative cholangiography']}, {'label': 'Cholangiography failure', 'description': 'From January 2018 to August 2018 all consecutive elective and emergency cholecystectomies performed with intraoperative failure of cholangiography', 'interventionNames': ['Radiation: intraoperative cholangiography']}], 'interventions': [{'name': 'intraoperative cholangiography', 'type': 'RADIATION', 'description': 'success or failure of cholangiography', 'armGroupLabels': ['Cholangiography failure', 'Cholangiography success']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40620', 'city': 'Jyväskylä', 'country': 'Finland', 'facility': 'Central Finland Central Hospital', 'geoPoint': {'lat': 62.24147, 'lon': 25.72088}}], 'overallOfficials': [{'name': 'Anne Mattila, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'consultant surgeon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jyväskylä Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Olli Helminen', 'investigatorAffiliation': 'Jyväskylä Central Hospital'}}}}