Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT03442205
Status:
UNKNOWN
Last Update Posted:
2018-03-01
First Post:
2018-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Common Bile Duct Stones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D042882', 'term': 'Gallstones'}], 'ancestors': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-28', 'studyFirstSubmitDate': '2018-02-17', 'studyFirstSubmitQcDate': '2018-02-17', 'lastUpdatePostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Adverse outcomes', 'timeFrame': '24 months', 'description': 'The patients developing complications/ the total patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Common Bile Duct Stone;', 'Laparoscopic Common Bile Duct Exploration;', 'ERCP;'], 'conditions': ['Common Bile Duct Stone']}, 'descriptionModule': {'briefSummary': 'ABSTRACT Introduction: Common bile duct (CBD) stone is a common clinical situation, especially in Asia area. Laparotomy and laparoscopic surgical procedure are often used for treatment. This study compares outcomes of different surgical procedures treating for the disease.\n\nMethods/design: This is a prospective, randomized, controlled multicenter trial with three treatment arms. One group underwent laparoscopic cholecystectomy (LC) + laparoscopic CBD exploration (LCBDE) + intraoperative endoscopic nasobiliary drainage ENBD + primary closure of CBD. The other underwent preoperative endoscopic retrograde cholangiopancreatography (ERCP) and subsequent LC and the third arm underwent laparoscopic cholecystectomy (LC) + laparoscopic CBD exploration (LCBDE) + primary closure of CBD. The duration of the entire trial is two years including prearrangement, follow-up and analyses.\n\nDiscussion: Despite the fact plenty evidences provided by meta-analyses suggests that these approaches would appear comparable. It is hopeful to fully address which would be the better approach with this RCT design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with age between 18 - 80 years.\n* Patients diagnosed with gallstones.\n* Patients diagnosed with common bile duct stone by one of the three exam (US、MRCP and CT).\n* Patients diagnosed with common bile duct stone by intro-operative cholangiography or transcystic exploration.\n* Patients understood the trial and accepted one of the three managements.\n\nExclusion Criteria:\n\n* Combined with Mirizzi syndrome and intrahepatic bile duct stones\n* Previous EST/endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic biliary drainage (PTBD)\n* History of upper abdominal surgery.\n* Serious heart, brain, lung, metabolic diseases history.\n* Pregnant women.\n* Unwillingness or inability to consent for the study.'}, 'identificationModule': {'nctId': 'NCT03442205', 'briefTitle': 'Treatment of Common Bile Duct Stones', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Randomized Clinical Trial Investigating the Best Method of Treatment of Common Bile Duct Stones', 'orgStudyIdInfo': {'id': 'TJDBPS03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'interventionNames': ['Procedure: LC + LCBDE + ENBD + primary closure of CBD']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'interventionNames': ['Procedure: ERCP technique + LC']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'interventionNames': ['Procedure: LC + LCBDE + primary closure of CBD']}], 'interventions': [{'name': 'LC + LCBDE + ENBD + primary closure of CBD', 'type': 'PROCEDURE', 'description': 'LC + LCBDE + ENBD + primary closure of CBD', 'armGroupLabels': ['Group A']}, {'name': 'ERCP technique + LC', 'type': 'PROCEDURE', 'description': 'ERCP technique + LC', 'armGroupLabels': ['Group B']}, {'name': 'LC + LCBDE + primary closure of CBD', 'type': 'PROCEDURE', 'description': 'LC + LCBDE + primary closure of CBD', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Renyi Qin, pHD', 'role': 'CONTACT', 'email': 'ryqin@tjh.tjmu.edu.cn', 'phone': '+8602783665314'}], 'facility': 'Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Hang Zhang, doctor', 'role': 'CONTACT', 'email': 'okashiiyo@126.com', 'phone': '+8602783665314'}], 'overallOfficials': [{'name': 'Renyi Qin, pHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tongji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Renyi Qin', 'investigatorAffiliation': 'Tongji Hospital'}}}}