Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-02-03 @ 4:41 AM
Study NCT ID:
NCT02050659
Status:
COMPLETED
Last Update Posted:
2015-03-10
First Post:
2014-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omentectomy in Radical Gastrectomy for Gastric Cancer Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-16', 'releaseDate': '2025-08-28'}], 'estimatedResultsFirstSubmitDate': '2025-08-28'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-09', 'studyFirstSubmitDate': '2014-01-28', 'studyFirstSubmitQcDate': '2014-01-29', 'lastUpdatePostDateStruct': {'date': '2015-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tumorload in the greater omentum', 'timeFrame': 'at the time of pathologic investigation'}]}, 'conditionsModule': {'conditions': ['Omentum', 'Stomach Neoplasms']}, 'referencesModule': {'references': [{'pmid': '27550526', 'type': 'DERIVED', 'citation': 'Jongerius EJ, Boerma D, Seldenrijk KA, Meijer SL, Scheepers JJ, Smedts F, Lagarde SM, Balague Ponz O, van Berge Henegouwen MI, van Sandick JW, Gisbertz SS. Role of omentectomy as part of radical surgery for gastric cancer. Br J Surg. 2016 Oct;103(11):1497-503. doi: 10.1002/bjs.10149. Epub 2016 Aug 23.'}]}, 'descriptionModule': {'briefSummary': 'In patients with gastric cancer, traditionally a complete omentectomy is performed as part of a radical gastrectomy with a modified D2 lymph node dissection. The omentectomy increases operation time significantly, especially in laparoscopic procedures. Patients remain more vulnerable for peritoneal infections and intestinal adhesions following omentectomy. Furthermore one can debate whether a complete omentectomy is indicated from an oncologic viewpoint. In the present study we prospectively evaluated the presence of tumor load in the greater omentum of patients with potentially curative gastric cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with a castric carcinoma who received an in potentially curative gastric resection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* an in potentially curative gastric cancer\n* age \\> 18 year\n\nExclusion Criteria:\n\n* palliative resection\n* age \\< 18 year'}, 'identificationModule': {'nctId': 'NCT02050659', 'acronym': 'OMEGA', 'briefTitle': 'Omentectomy in Radical Gastrectomy for Gastric Cancer Trial', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Omentectomy in Radical Gastrectomy for Gastric Cancer Trial', 'orgStudyIdInfo': {'id': 'OMEGA'}}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Centre', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'S.S. Gisbertz', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-28', 'type': 'RELEASE'}, {'date': '2025-09-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Suzanne S. Gisbertz, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}