Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-31 @ 9:57 PM
Study NCT ID:
NCT04308993
Status:
COMPLETED
Last Update Posted:
2020-03-16
First Post:
2020-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Percutaneous Endoscopic Biliary Exploration in Complex Biliary Stone Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041761', 'term': 'Cholecystolithiasis'}], 'ancestors': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008096', 'term': 'Lithotripsy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D059708', 'term': 'Ultrasonic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-12', 'studyFirstSubmitDate': '2020-03-06', 'studyFirstSubmitQcDate': '2020-03-12', 'lastUpdatePostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'obstructive jaundice', 'timeFrame': 'one day', 'description': 'biochemical evidence (Liver function test) of improvement'}], 'primaryOutcomes': [{'measure': 'symptoms', 'timeFrame': 'at least one year follow up', 'description': 'success rate of biliary stone clearance or asymptomatic derbies'}], 'secondaryOutcomes': [{'measure': 'ultrasound', 'timeFrame': 'one month', 'description': 'evidence of stone clearance'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biliary Stones']}, 'descriptionModule': {'briefSummary': 'Patients with complex biliary stone disease are challenging to treat. The investigator present their experience in using urological interventions to treat challenging biliary stones.\n\nMethods:\n\nFifteen patients with biliary calculi underwent 21 interventions using either extracorporeal shock wave lithotripsy (ESWL), percutaneous transhepatic choledochoscopy, percutaneous transcystic choledochoscopy, or a combination of these.', 'detailedDescription': 'The investigator conducted a retrospective review to investigate the outcomes of urological treatments for biliary calculi from January 1, 1999, to August 31, 2016, focusing on percutaneous endoscopic methods and/or ESWL. The primary outcomes of interest were symptom- and stone-free rates, length of hospital stay, and complications. Our institutional ethics review board approved the study (IRB-2018-01-119). Due to the retrospective nature of the study, the need for informed consent was waived. One endourologist evaluated all patients preoperatively.\n\nUrological intervention techniques The three different approaches used (ESWL, PTHC, and PTCC) are described below.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Most patients were elderly (median age, 60 years). The male-to-female ratio was higher than the norm for biliary stones (1:1.4). The most common reasons for failure of conventional endoscopic retrograde cholangiopancreatography (ERCP) were high American Society of Anesthesia (ASA) score (8 patients 53%), technical failure of ERCP (4 patients, 27%), previous Roux-en-Y gastric bypass (two patients, 13%), and post-common bile duct (CBD) injury with T-tube insertion (one patient, 7%). The stone sites were the CBD, gallbladder, and intrahepatic bile duct in nine (60%), three (20%), and three (20%) patients, respectively', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* complete records\n\nExclusion Criteria:\n\n* lost follow up'}, 'identificationModule': {'nctId': 'NCT04308993', 'briefTitle': 'Percutaneous Endoscopic Biliary Exploration in Complex Biliary Stone Disease', 'organization': {'class': 'OTHER', 'fullName': 'Imam Abdulrahman Bin Faisal University'}, 'officialTitle': 'Percutaneous Endoscopic Biliary Exploration in Complex Biliary Stone Disease: Cohort Study', 'orgStudyIdInfo': {'id': 'IAU-PEBE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'percutaneous transhepatic choledochoscopy', 'type': 'PROCEDURE', 'otherNames': ['extracorporeal shock wave lithotripsy (ESWL)'], 'description': 'percutaneous transhepatic choledochoscopy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imam Abdulrahman Bin Faisal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of Surgery', 'investigatorFullName': 'Hanan Mesfer Alghamdi', 'investigatorAffiliation': 'Imam Abdulrahman Bin Faisal University'}}}}