Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT05356156
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-05-02
First Post:
2022-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Safe Study of Routine Closure of Mesenteric Defects Versus Non-closure After Radical Gastrectomy
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1968}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-29', 'studyFirstSubmitDate': '2022-04-23', 'studyFirstSubmitQcDate': '2022-04-29', 'lastUpdatePostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of internal hernia within 3 years after surgery', 'timeFrame': '3 years', 'description': 'Internal hernia were identified by surgical exploration or abdominal computed tomography (CT) from surgical and medical records during the postoperative 3 years of follow-up.'}], 'secondaryOutcomes': [{'measure': 'The incidence of intraoperative complications', 'timeFrame': 'up to 2 hours after surgery', 'description': 'The intraoperative complications occur from the beginning of skin cutting to the completion of sewn skin, including surgical complications, anesthesia related complications and pneumoperitoneum related complications.'}, {'measure': 'Incidence of postoperative intestinal obstruction', 'timeFrame': '3 years', 'description': 'Refers to the incidence of postoperative intestinal obstruction observed during follow-up period.'}, {'measure': 'Overall survival at 3 years after surgery', 'timeFrame': '3 years', 'description': 'The overall survival of patients with gastric or esophagogastric junction adenocarcinoma are evaluated at 3 years after radical gastrectomy.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'To compare the incidence of internal hernia, overall survival and short-term surgical safety of routine closure of the surgically created mesenteric defects versus non-closure for patients with adenocarcinoma of the gastric or esophagogastric junction who underwent radical gastrectomy (D1+/D2 lymph node dissection).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-75 years；\n* Primary lesion is diagnosed with endometrial biopsy as adenocarcinoma of the stomach or esophagogastric junction, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), mixed adenocarcinoma, etc.；\n* The gastric primary lesion is located in the antrum, body or fundus of stomach or the esophagogastric junction. It is expected that radical gastrectomy with D1+/D2 lymph node dissection achieves R0 resection (multiple primary cancers are also applicable)；\n* BMI(Body Mass Index) \\< 30 kg/m2；\n* No history of upper abdominal surgery (except for laparoscopic cholecystectomy)；\n* No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.；\n* Preoperative ECOG (Eastern Cooperative Oncology Group) performance status score 0 or 1；\n* Preoperative ASA (American Society of Anesthesiologists) scoring I-III；\n* Sufficient vital organ functions；\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Women during pregnancy or lactation；\n* Suffer from other malignant tumors within 5 years；\n* Preoperative body temperature ≥ 38°C or complicated with infectious diseases requiring systemic treatment；\n* Severe mental illness；\n* Severe respiratory disease；\n* Severe liver and kidney dysfunction；\n* History of unstable angina or myocardial infarction within 6 months；\n* History of cerebral infarction or cerebral hemorrhage within 6 months；\n* Continuous application of glucocorticoid within 1 month (except for topical application)；\n* Accompanied by gastric cancer complications (bleeding, perforation, obstruction, etc.) ；\n* The patient has participated in or is participating in other clinical studies (within 6 months).'}, 'identificationModule': {'nctId': 'NCT05356156', 'briefTitle': 'The Safe Study of Routine Closure of Mesenteric Defects Versus Non-closure After Radical Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'A Multicenter, Randomized, Controlled Clinical Trial of the Safety of Mesenteric Defects Closure After Radical Gastrectomy', 'orgStudyIdInfo': {'id': 'JSGCU-2203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Closure of the mesenteric defects', 'description': 'Closure of the mesenteric defects will be performed after radical gastrectomy in patients with gastric or esophagogastric junction adenocarcinoma.', 'interventionNames': ['Procedure: Closure of the mesenteric defects']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-closure of the mesenteric defects', 'description': 'Non-closure of the mesenteric defects will be performed after radical gastrectomy in patients with gastric or esophagogastric junction adenocarcinoma.', 'interventionNames': ['Procedure: Non-closure of the mesenteric defects']}], 'interventions': [{'name': 'Closure of the mesenteric defects', 'type': 'PROCEDURE', 'description': 'The surgically created mesenteric defects will be closed after radical gastrectomy with D1+/D2 lymph node dissection.', 'armGroupLabels': ['Closure of the mesenteric defects']}, {'name': 'Non-closure of the mesenteric defects', 'type': 'PROCEDURE', 'description': 'The surgically created mesenteric defects will not be closed after radical gastrectomy with D1+/D2 lymph node dissection.', 'armGroupLabels': ['Non-closure of the mesenteric defects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Zekuan Xu, M.D., Ph.D.', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Zekuan Xu, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'xuzekuan@njmu.edu.cn', 'phone': '+86-025-68306844'}], 'overallOfficials': [{'name': 'Zekuan Xu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}