Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-03-05 @ 1:33 AM
Study NCT ID:
NCT04072250
Status:
COMPLETED
Last Update Posted:
2019-09-13
First Post:
2019-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgery for Recurrent Intrahepatic Cholangiocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018281', 'term': 'Cholangiocarcinoma'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006498', 'term': 'Hepatectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-11', 'studyFirstSubmitDate': '2019-08-26', 'studyFirstSubmitQcDate': '2019-08-26', 'lastUpdatePostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '1977~2014', 'description': 'Including overall survival and disease free survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Recurrent intrahepatic cholangiocarcinoma', 'Intrahepatic cholangiocarcinoma', 'Repeat hepatectomy', 'Metastasectomy'], 'conditions': ['Cholangiocarcinoma, Intrahepatic', 'Recurrence Cholangiocarcinoma', 'Re-hepatectomy']}, 'descriptionModule': {'briefSummary': 'The investigators retrospectively reviewed the participants suffering from recurrent intrahepatic cholangiocarcinoma after curative resection and aimed to explore the predictive factors for recurrence and clarify the potential benefit of repeat hepatectomy or/with metastasectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Between January 1977 and December 2014, 452 patients underwent curative-intent, different extent of hepatectomy for ICC in the Department of General Surgery, Chang Gung Memorial Hospital, Linkou branch, Taiwan. Only 216 patients fulfilled selection criteria aforementioned.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* R0 resection for intrahepatic cholangiocarcinoma at initial diagnosis.\n\nExclusion Criteria:\n\n* (1)Patient with R1 or R2 resection\n* (2)Distant metastasis noted when laparotomy\n* (3)Surgical mortality'}, 'identificationModule': {'nctId': 'NCT04072250', 'briefTitle': 'Surgery for Recurrent Intrahepatic Cholangiocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Surgery for Recurrent Intrahepatic Cholangiocarcinoma: a Promise or an Excess?', 'orgStudyIdInfo': {'id': '201701127B0'}}, 'armsInterventionsModule': {'interventions': [{'name': 'hepatectomy', 'type': 'PROCEDURE', 'description': 'Hepatectomy for patients with recurrent intrahepatic cholanigocarcinoma'}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital Linkou Branch', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}