Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-02-20 @ 4:22 PM
Study NCT ID:
NCT05114369
Status:
COMPLETED
Last Update Posted:
2021-11-10
First Post:
2021-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Timing of Completion Radical Cholecystectomy Determine the Survival in Incidental Carcinoma Gallbladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005706', 'term': 'Gallbladder Neoplasms'}], 'ancestors': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-01', 'size': 580655, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-05T03:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-05', 'studyFirstSubmitDate': '2021-10-11', 'studyFirstSubmitQcDate': '2021-11-05', 'lastUpdatePostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival based on timing of completion radical cholecystectomy', 'timeFrame': '01.01.2009 to 31.12.2018', 'description': 'Overall and disease free survival'}], 'secondaryOutcomes': [{'measure': 'Determinants of factors associated with survival in incidental gallbladder carcinoma', 'timeFrame': '01.01.2009 to 31.12.2018', 'description': 'Factors related to primary surgery (residual disease, primary T stage), type of resection (Wedge resection, Segment 4B-5 excision or Common bile duct excision), tumor characteristics (differentiation and lymohovascular invasion) and final stage (AJCC 8th edition)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Incidental', 'Gallbladder cancer', 'Re-resection', 'Survival'], 'conditions': ['Gall Bladder Carcinoma', 'Survival']}, 'descriptionModule': {'briefSummary': 'Various factors determine the long term survival in this non-uniform cohort of incidental gallbladder cancer. Timing of re-intervention is suggested to play an important role in the outcome. Few centers are proponents of early surgery in order to prevent dissemination, while others have suggested an intentional delay of 3 months to filter out cases with aggressive pathology. In the present study, investigators intend to evaluate the factors affecting survival in incidental Gallbladder Cancer (IGBC) with special reference to timing of re-intervention.', 'detailedDescription': 'Surgical Gastroenterology department at our institute is a tertiary referral center for hepatobiliary malignancies; covering a large part of North and North-east India. The details and progress reports of patients of Gallbladder Cancer (GBC) being referred to and treated at the institute is maintained in a prospective manner on hospital data base. This includes demographic data, presenting complains, details of relevant investigations done outside and in the hospital, previous surgery, pre-hospital course, operative findings, post operative course and final histopathology. Being a retrospective analysis of data not affecting clinical outcomes, ethical approval was not taken. During the study period (Jan 2009 to Dec 2018), 1049 participants with diagnosis of GBC (including 91 IGBC participants) were admitted; 239/958 participants with diagnosis of GBC and 48/91 with diagnosis of GBC could undergo resection with curative intent. Information regarding adjuvant therapy, recurrence, and survival were retrieved through data maintained on follow up out-patient cards till December 2019. Few participants who stopped visiting the hospital were contacted telephonically or through letters. All available histopathology blocks and slides following the index cholecystectomy were re-reviewed by the pathologists in the institute. Tumor type, differentiation and primary T stage were documented for majority of cases. Interval between index cholecystectomy and date of re-operation was calculated for all the participants and divided into 3 groups: Early (\\<4weeks), Intermediate (4-12 weeks) and Late (\\>12 weeks). Primary objective was to assess the effect of tumor characteristics and the time gap (between index surgery and re-resection) on overall survival following curative (R0/R1) resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All incidental carcinoma gallbladder patients who were admitted for possible curative resection during the study period (Jan 2009 to Dec 2018)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll incidental carcinoma gallbladder patients who could undergo curative resection during the study period (Jan 2009 to Dec 2018)\n\nExclusion Criteria:\n\nMetastasis on preoperative investigation or on staging laparoscopy'}, 'identificationModule': {'nctId': 'NCT05114369', 'acronym': 'IGBC', 'briefTitle': 'Does Timing of Completion Radical Cholecystectomy Determine the Survival in Incidental Carcinoma Gallbladder', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sanjay Gandhi Postgraduate Institute of Medical Sciences'}, 'officialTitle': 'Does Timing of Completion Radical Cholecystectomy Determine the Survival Outcome in Incidental Carcinoma Gallbladder - a Single Center Retrospective Analysis', 'orgStudyIdInfo': {'id': '00'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early (<4weeks), Intermediate (4-12 weeks) and Late (>12 weeks)', 'description': 'Interval between index cholecystectomy and radical re-resection with curative intent', 'interventionNames': ['Procedure: Curative surgery']}], 'interventions': [{'name': 'Curative surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['Early (<4weeks), Intermediate (4-12 weeks) and Late (>12 weeks)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The final data sheet can be shared and not the individual data as the data was retrieved from online database'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanjay Gandhi Postgraduate Institute of Medical Sciences', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}