Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT02302794
Status:
UNKNOWN
Last Update Posted:
2014-11-27
First Post:
2014-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter Clinical Trial on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061887', 'term': 'Conversion to Open Surgery'}, {'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1056}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-25', 'studyFirstSubmitDate': '2014-11-25', 'studyFirstSubmitQcDate': '2014-11-25', 'lastUpdatePostDateStruct': {'date': '2014-11-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year disease free survival rate', 'timeFrame': 'three years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Locally Advanced Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'evaluate the long-term efficacy and safety of oncology between D2 laparoscopic approach distal gastric resection (distal gastrectomy, D2 lymph node dissection) with the current standard surgical treatment model D2 open approach distal gastric resection (distal gastrectomy, D2 lymphadenectomy).', 'detailedDescription': 'Study type：Interventional Study phase：Phase III Objectives of Study：to evaluate the long-term efficacy and safety of oncology between D2 laparoscopic approach distal gastric resection (distal gastrectomy, D2 lymph node dissection) with the current standard surgical treatment model D2 open approach distal gastric resection (distal gastrectomy, D2 lymphadenectomy).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years \\~ 75 years;\n2. the primary adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma);\n3. clinical stage T2-4a, N0-3, M0 (according to AJCC-7th TNM staging);\n4. to perform distal gastrectomy, D2 lymph node dissection surgical can obtain R0 resection (multiple primary cancers also apply)\n5. ECOG performance status 0/1;\n6. ASA score I-III;\n7. patient informed consent.\n\nExclusion Criteria:\n\n1. pregnant or lactating women;\n2. serious mental illness;\n3. upper abdominal surgery (except laparoscopic cholecystectomy );\n4. gastric surgery (including for gastric ESD / EMR);\n5. imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm)\n6. other malignant diseases in 5 years;\n7. implemented or recommended neoadjuvant therapy in patients with gastric cancer ;\n8. have unstable angina or myocardial infarction within six months; (9) have cerebral infarction or cerebral hemorrhage within 6 months; (10) sustained systemic glucocorticoid treatment history within 1 month; (11) have other diseases needed operative treatment at the same time; (12) complications (bleeding, perforation, obstruction) required emergency surgery; (13) Pulmonary function tests FEV1 \\<50% of predicted value.'}, 'identificationModule': {'nctId': 'NCT02302794', 'briefTitle': 'A Multicenter Clinical Trial on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Long-term Outcomes Between Laparoscopy-assisted and Open Distal Subtotal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': 'ChiCTR-TRC-14004877'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'open surgery', 'description': 'Conventional procedure', 'interventionNames': ['Procedure: open surgery']}, {'type': 'EXPERIMENTAL', 'label': 'laparoscopic surgery', 'description': 'Minimum invasive procedure', 'interventionNames': ['Procedure: laparoscopic surgery']}], 'interventions': [{'name': 'open surgery', 'type': 'PROCEDURE', 'otherNames': ['group A', 'open'], 'description': 'Patients in this arm undergo radical resection of gastric cancer in open surgery.Open surgery is a conventional technique for gastric cancer patients.', 'armGroupLabels': ['open surgery']}, {'name': 'laparoscopic surgery', 'type': 'PROCEDURE', 'otherNames': ['group B', 'laparoscopic'], 'description': 'Patients in this arm undergo radical resection of gastric cancer in laparoscopic surgery.Laparoscopic surgery is a new and minimum invasive technique for gastric cancer patients.', 'armGroupLabels': ['laparoscopic surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guobin Wang, MD,PhD', 'role': 'CONTACT', 'email': 'wangguobin1954@126.com', 'phone': '+86 027 85726139'}, {'name': 'Xinghua Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Shi Wang, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Union Hospital, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Guobin Wang, MD,PhD', 'role': 'CONTACT', 'email': 'wangguobin1954@126.com', 'phone': '+86 027 85726139'}], 'overallOfficials': [{'name': 'Guobin Wang, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, {'name': 'Kaixiong Tao, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cai Kailin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate chief physician of gastrointestinal surgery', 'investigatorFullName': 'Cai Kailin', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}