Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2026-03-06 @ 2:46 AM
Study NCT ID:
NCT05402618
Status:
COMPLETED
Last Update Posted:
2022-06-02
First Post:
2022-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimally Invasive Versus Open Surgery for PHC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018285', 'term': 'Klatskin Tumor'}], 'ancestors': [{'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 783}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-30', 'studyFirstSubmitDate': '2022-05-26', 'studyFirstSubmitQcDate': '2022-05-30', 'lastUpdatePostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative length of stay', 'timeFrame': 'up to 90 days', 'description': 'defined as the time from being admitted to hospital to discharge'}, {'measure': 'Overall survival', 'timeFrame': 'through study completion, an average of 5 year', 'description': 'defined as the duration from the first day after surgery to either the date of death or the last follow-up'}], 'secondaryOutcomes': [{'measure': 'Operation time', 'timeFrame': 'intraoperative', 'description': 'defined as the time from skin incision or trocar placement to complete skin closure'}, {'measure': 'postoperative complications', 'timeFrame': 'up to 90 days', 'description': 'Postoperative complications were reviewed within 90 days after surgery and graded according to Clavien-Dindo (CD) classification system.Postoperative biliary leakage, hemorrhage, and liver failure were defined and classified according to the criteria set out by the International Study Group of Liver Surgery (ISGLS). Wound infection was defined as purulent drainage from the incision or/and positive findings of culture of the fluid or tissue aseptically obtained from the incision.'}, {'measure': 'Reoperation within 90 days', 'timeFrame': 'up to 90 days', 'description': 'defined as any reoperation within 90 days'}, {'measure': 'Mortality', 'timeFrame': 'up to 90 days', 'description': 'defined as any death within 30 days and 90 days, respectively'}, {'measure': 'Readmission within 90 days', 'timeFrame': 'up to 90 days', 'description': 'defined as any readmission within 90 days'}, {'measure': 'Operative details', 'timeFrame': 'intraoperative', 'description': 'including blood transfusion, vascular resection, number of resected lymph nodes'}, {'measure': 'R0 resection', 'timeFrame': 'intraoperative', 'description': 'defined as tumor-free margins in all the reported surgical margins (biliary and circumferential margins)'}, {'measure': 'Intraoperative blood loss', 'timeFrame': 'intraoperative', 'description': 'recorded by the anesthetist using a vacuum system'}, {'measure': 'Vessel reconstruction', 'timeFrame': 'intraoperative', 'description': 'defined as any repair or replacement of major vessels during surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laparoscopic', 'minimally invasive', 'open resection'], 'conditions': ['Perihilar Cholangiocarcinoma']}, 'referencesModule': {'references': [{'pmid': '37138243', 'type': 'DERIVED', 'citation': 'Wang M, Qin T, Zhang H, Li J, Deng X, Zhang Y, Zhao W, Fan Y, Li D, Chen X, Feng Y, Zhu S, Xing Z, Yu G, Xu J, Xie J, Dou C, Ma H, Liu G, Shao Y, Chen W, Liu J, Liu J, Yin X, Qin R. Laparoscopic versus open surgery for perihilar cholangiocarcinoma: a multicenter propensity score analysis of short- term outcomes. BMC Cancer. 2023 May 3;23(1):394. doi: 10.1186/s12885-023-10783-9.'}]}, 'descriptionModule': {'briefSummary': 'Brief Summary: This is a multicentric, retrospective, real-world study to investigate the surgical outcomes of minimally invasive surgery compared with open surgery for Perihilar Cholangiocarcinoma (PHC), with the perioperative characteristics and long-term overall survival being compared. We aimed to find out whether the minimally invasive surgery is safe or feasible for PHC. And we also want to find out patients with what kind of characteristic can be benefit from the minimally invasive surgery compared with the open approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A retrospective review of a real-world institutional databases from 10 hospitals in China identified PHC patients who underwent curative LS or OP surgery (including R0 and R1) form January 2012 and January 2019.Patients with pathologically confirmed PHC and without any evidence of distant metastasis by preoperative examinations were included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHistologically confirmed PHC.\n\nExclusion Criteria:\n\n1. Peritoneal seeding or metastasis to the liver, para-aortic lymph nodes, or distant sites;\n2. Non-adenocarcinoma histology;\n3. Incomplete clinical data.'}, 'identificationModule': {'nctId': 'NCT05402618', 'briefTitle': 'Minimally Invasive Versus Open Surgery for PHC', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Minimally Invasive Versus Open Surgery for Perihilar Cholangiocarcinoma(PHC)：A Multicenter Real-world Study', 'orgStudyIdInfo': {'id': 'TJDBPS10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'minimally invasive surgery', 'interventionNames': ['Other: No intervention']}, {'label': 'open surgery', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'This is an observational study without any intervention.', 'armGroupLabels': ['minimally invasive surgery', 'open surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Renyi Qin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Renyi Qin', 'investigatorAffiliation': 'Tongji Hospital'}}}}