Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-10 @ 2:56 PM
Study NCT ID:
NCT03098251
Status:
UNKNOWN
Last Update Posted:
2017-04-12
First Post:
2017-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of 3D Typing on Surgical Treatment of Hepatolithiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-11', 'studyFirstSubmitDate': '2017-03-20', 'studyFirstSubmitQcDate': '2017-03-27', 'lastUpdatePostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'residual ratio of biliary stone', 'timeFrame': '3 months', 'description': 'residual ratio of biliary stone diagnosed within 3 months'}], 'secondaryOutcomes': [{'measure': 'postoperative complications', 'timeFrame': '6 months', 'description': 'postoperative complications diagnosed within 6 months'}, {'measure': 'residual lesions', 'timeFrame': '6 months', 'description': 'residual lesions diagnosed within 6 months'}, {'measure': 'Health economics index', 'timeFrame': '3 months', 'description': 'Health economics index within 3 months'}, {'measure': 'mortality', 'timeFrame': '3 months', 'description': 'mortality occured within 3 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatolithiasis', 'Surgery']}, 'descriptionModule': {'briefSummary': 'According to a large amount of case affected with hepatolithiasis, we developed a typing system of Hepatolithiasis based on 3D digital conformation. And we hypothesized that it could predict a more precise construction of this disease, hence, typing by 3D conformation will improve the outcome of surgical treatment.The investigators will use a multicenter ambispective cohort study to test this hypothesis.', 'detailedDescription': 'According to a large amount of case affected with hepatolithiasis, we developed a typing system of Hepatolithiasis based on 3D digital conformation. And we hypothesized that it could predict a more precise construction of this disease, hence, typing by 3D conformation will improve the outcome of surgical treatment.The investigators will use a multicenter ambispective cohort study to test this hypothesis. In this cohort study, two group will be enrolled to compare the outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged from 18 to 65 years old\n* Without gender restriction\n* With a favorable liver function of Child-Pugh A to B\n* No contraindications to surgery and anesthesia\n* Diagnosed with Hepatolithiasis and Signed informed consent.\n\nExclusion Criteria:\n\n* Diffused type of Hepatolithiasis\n* Impairment in liver function\n* Severe disorders in vital organ\n* Accompanied with tumors.'}, 'identificationModule': {'nctId': 'NCT03098251', 'briefTitle': 'Effect of 3D Typing on Surgical Treatment of Hepatolithiasis', 'organization': {'class': 'OTHER', 'fullName': 'Southwest Hospital, China'}, 'officialTitle': 'Efficacy of 3D Typing and Routine Typing on Surgical Treatment of Hepatolithiasis', 'orgStudyIdInfo': {'id': 'SWHB017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D typing', 'description': 'typing the patient with 3D typing system and give treatment according preestablished algorism in our center.', 'interventionNames': ['Procedure: 3D typing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'routine typing', 'description': 'typing the patient with routine typing system and give treatment according preestablished algorism in our center.', 'interventionNames': ['Procedure: routine typing']}], 'interventions': [{'name': '3D typing', 'type': 'PROCEDURE', 'description': 'typing the patient with 3D typing system and give specific treatment', 'armGroupLabels': ['3D typing']}, {'name': 'routine typing', 'type': 'PROCEDURE', 'description': 'typing the patient with routine typing system and give specific treatment', 'armGroupLabels': ['routine typing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400038', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xiaobin Feng, MD', 'role': 'CONTACT'}], 'facility': 'Southwest Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Xiaobin Feng, MD', 'role': 'CONTACT', 'email': 'fengxiaobin200708@aliyun.com', 'phone': '+86-2368765297'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southwest Hospital, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical professor', 'investigatorFullName': 'feng xiaobin', 'investigatorAffiliation': 'Southwest Hospital, China'}}}}