Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-31 @ 10:24 PM
Study NCT ID:
NCT05068635
Status:
COMPLETED
Last Update Posted:
2021-10-06
First Post:
2021-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of Distal Gastrectomy for the Treatment of Gastric Cancer (a Case Series)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-24', 'studyFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2021-09-24', 'lastUpdatePostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who died for gastric cancer after distal gastrectomy', 'timeFrame': 'Fourty four months', 'description': 'Mortality rate for patients who underwent distal gastrectomy for gastric cancer'}, {'measure': 'Number of patients who developped morbidity after subgastrectmy for gastric cancer', 'timeFrame': 'Forty for months', 'description': 'Mortality rate for patients who underwent distal gastrectomy for gastric cancer'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastric cancer, gastric adenocarcinoma, total gastrectomy, subtotal gastrectomy, distal gastrectomy.'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'Case series of a retrospective study of patients operated for distal adenocarcinoma of the stomach, either by total gastrectomy or distal gastrectomy at Ibn Rochd University Hospital in Casablanca, with the analysis of outcome of patients on a follow up periode of three years and eight months.', 'detailedDescription': 'Thirty (30) patients were treated for gastric cancer and were included in this study. The average age was 64 years, the sex ratio 1.5. Twenty eight patients underwent a distal gastrectomy and 2 patients underwent total gastrectomy. The median number of lymph nodes resected was 6 following distal gastrectomy versus 26 after total gastrectomy. Resection margins were clean except for three patients who underwent a distal gastrectomy. Postoperative complicationsoccured in 05 patients. They were mainly infectious, anastomotic leakage. Two 2 cases of postoperative mortality (\\<30 days) among patients with distal gastrectomy was noted. A progression to metastasis was found in 3 patients with subtotal gastrectomy, two of whom had insufficient lymph node clearance, compared to no cases of metastasis in patients with total gastrectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study concerns patients who have been treated in our service for gastric cancer from fifteen years to unlimited age', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Patients bwith gastric cancer with histologic confirmation\n\nExclusion Criteria: Incomplete patients records'}, 'identificationModule': {'nctId': 'NCT05068635', 'briefTitle': 'Evaluation of the Efficacy of Distal Gastrectomy for the Treatment of Gastric Cancer (a Case Series)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Ibn Rochd'}, 'officialTitle': 'Evaluation of the Efficacy of Distal Gastrectomy for the Treatment of Gastric Cancer (a Case Series)', 'orgStudyIdInfo': {'id': 'SK2021'}}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sylvestre KABURA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Sylvestre KABURA', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Ibn Rochd'}}}}