Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-27 @ 10:06 AM
Study NCT ID:
NCT05663450
Status:
COMPLETED
Last Update Posted:
2022-12-23
First Post:
2022-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extended Resection After Positive Intraoperative Pathology in Gastric Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D000072662', 'term': 'Margins of Excision'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D065308', 'term': 'Morphological and Microscopic Findings'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 679}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-20', 'studyFirstSubmitDate': '2022-12-12', 'studyFirstSubmitQcDate': '2022-12-20', 'lastUpdatePostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of R1-resection during oncologic surgery', 'timeFrame': 'intraoperative pathology', 'description': 'Rate of incomplete tumour resection (macroscopic: R2; microscopic: R1) during the surgical resection of gastric cancer patients'}], 'secondaryOutcomes': [{'measure': 'Post-surgical survival', 'timeFrame': 'months (median follow-up: 29 months)', 'description': 'post-surgical survival after radical surgical resection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['excision margin; prognosis; gastric cancer; resection'], 'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '37222663', 'type': 'DERIVED', 'citation': 'Plum PS, Barutcu AG, Pamuk A, Mallmann C, Chon SH, Chiapponi C, Dubbers M, Hellmich M, Moenig SP, Quaas A, Hoelscher AH, Bruns CJ, Alakus H. Extension of resection after positive intraoperative pathology during surgery for gastric and gastroesophageal junction adenocarcinoma: a retrospective cohort study. Int J Surg. 2023 Aug 1;109(8):2324-2333. doi: 10.1097/JS9.0000000000000484.'}]}, 'descriptionModule': {'briefSummary': 'Of 737 consecutive patients undergoing (sub)total gastrectomy for gastric or GEJ adenocarcinoma, 679 cases with curative intent surgery between 05/1996 and 03/2019 were included. Patients were categorized into: i) R0 without further resection (direct R0), ii) R0 after positive IOC and extension of resection (converted R0) and iii) R1.', 'detailedDescription': 'This retrospective cohort study was performed at our tertiary referral center at the University Hospital of Cologne, Germany. Since 1st May 1996 medical charts of patients who undergo surgery for gastric or GEJ adenocarcinomas are collected in a department internal database for research analyses (Chairman since 05/2016 CJ Bruns, from 5/1996-4/2016 AH Hölscher).\n\nIn this study, patients undergoing curative surgery between 1st May 1996 and 31st March 2019 with (sub)total gastrectomy for gastric or GEJ adenocarcinoma were included. Palliative resections and resections with transthoracic esophagectomy and gastric pull-up were excluded.\n\nDemographics, perioperative treatment, survival and clinicopathologic data were obtained. Medical records were reviewed and complications were categorized according to Clavien-Dindo classification.\n\nDepending on IOCs, extended resection and final pathology report a treatment flow-chart was created (Figure 1): Patients were grouped on a) IOC received (yes/no), b) IOC positive (yes/no), c) extended resection (yes/no), d) second IOC (IOC2; yes/no), e) IOC2 positive (yes/no) and final pathology results (R0/R1). The decision to perform IOC and to carry out extended resection in case of positive IOC was at the discretion of the treating surgeon. Patients were then categorized into 3 subgroups according to final R status: R0 after extended resection (i.e. converted R0), R0 without extended resection (i.e. direct R0) and R1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '66 Years', 'minimumAge': '59 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This retrospective cohort study was performed at our tertiary referral center at the University Hospital of Cologne, Germany. Since 1st May 1996 medical charts of patients who undergo surgery for gastric or GEJ adenocarcinomas are collected in a department internal database for research analyses (Chairman since 05/2016 CJ Bruns, from 5/1996-4/2016 AH Hölscher).\n\nIn this study, patients undergoing curative surgery between 1st May 1996 and 31st March 2019 with (sub)total gastrectomy for gastric or GEJ adenocarcinoma were included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 18 years\n* tumor resection via total gastrectomy and subtotal esophagectomy\n\nExclusion Criteria:\n\n* no additional other solid or hematological neoplasias in the medical history\n* pregnancy\n* surgical procedures in palliative intention'}, 'identificationModule': {'nctId': 'NCT05663450', 'briefTitle': 'Extended Resection After Positive Intraoperative Pathology in Gastric Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Cologne'}, 'officialTitle': 'Extension of Resection After Positive Intraoperative Pathology During Surgery of Gastric and Gastroesophageal Junction Adenocarcinoma', 'orgStudyIdInfo': {'id': 'HA_Pos_Margins_Gastrectomy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with direct R0 (in primary intraoperative pathology consultation)', 'description': 'patients undergoing (sub)total gastrectomy for gastric or GEJ adenocarcinoma with R0 without further resection (direct R0)'}, {'label': 'patients with converted R0 (in second intraoperative pathology consultation)', 'description': 'patients undergoing (sub)total gastrectomy for gastric or GEJ adenocarcinoma with R0 after positive IOC and extension of resection (converted R0)'}, {'label': 'patients with remaining R1 (after final intraoperative pathology consultation)', 'description': 'patients undergoing (sub)total gastrectomy for gastric or GEJ adenocarcinoma with R1 resection.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hakan Alakus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Cologne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data is available by the responsible PI on reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor and Senior Physician; Department of General, Visceral, Cancer and Transplantation Surgery', 'investigatorFullName': 'Hakan Alakus', 'investigatorAffiliation': 'University Hospital of Cologne'}}}}