Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-29 @ 10:58 AM
Study NCT ID:
NCT02806661
Status:
UNKNOWN
Last Update Posted:
2016-06-20
First Post:
2016-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Vagus Nerve-preserving RADG and Conventional RADG for AGC
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-17', 'studyFirstSubmitDate': '2016-04-16', 'studyFirstSubmitQcDate': '2016-06-17', 'lastUpdatePostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence rate', 'timeFrame': 'up to 36 months', 'description': 'Recurrence rate in 3 years after operating.'}], 'secondaryOutcomes': [{'measure': '3-years survival rate', 'timeFrame': 'up to 36 months', 'description': 'Survival rate in 3 years after operating.'}, {'measure': 'The rate of Calculus of gallbladder', 'timeFrame': 'up to 12 months', 'description': 'The rate of gallbladder calculus in 1 year after operating, which is diagnosed by ultrasound.'}, {'measure': 'Number of retrieving lymph nodes', 'timeFrame': 'up to 1 week', 'description': 'The number of dissecting lymph nodes during operating.'}, {'measure': 'Inflammatory factors', 'timeFrame': '6 h, 12 h, 24 h, and 72h after operating', 'description': 'Detecting Interleukin -10 (IL-10), C-reactive protein (CRP) and Tumor Necrosis Factor (TNF-a) in 6 h, 12 h, 24 h, and 72h after operating.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Robotic surgery', 'Vagus nerve preserving'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'Through comparative observation of robot vagus nerve preserving distal gastric cancer radical surgery and conventional robot distal gastric cancer radical surgery (not reserved vagus nerve) operative and postoperative indicators, and evaluating the feasibility and safety of vagus nerve preserving distal gastric cancer radical surgery in advanced gastric cancer. Which can provide the evidences for the clinical development of the preserving function gastric cancer surgery.', 'detailedDescription': 'Compare the robot vagus nerve preserving distal gastric cancer radical surgery and conventional robot distal gastric cancer radical surgery (not reserved vagus nerve). Observe the operative and postoperative indicators, and evaluate the feasibility and safety of vagus nerve preserving distal gastric cancer radical surgery in advanced gastric cancer. Which can provide the evidences for the clinical development of the preserving function gastric cancer surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, aged less than 70 years and more than 18 years;\n2. Underwent gastroscopy and biopsy - preoperative definite for advanced gastric cancer invasion depth is T2, T3;\n3. The lesion is in the middle and lower stomach;\n4. Magix routine upper gastrointestinal barium meal, endoscopic ultrasonography, abdominal CT and chest X ray examination, clearly no nerve invasion and adjacent organ invasion and distant metastasis;\n5. The preoperative examination of lung, liver, heart, renal insufficiency, surgical contraindication;\n6. The preoperative abdominal CT or abdominal ultrasound without biliary disease and gallbladder stones;\n7. No history of gastrointestinal dysfunction and other malignant tumor history;\n8. The patients voluntarily participate in the study and signed informed consent.\n\nExclusion Criteria:\n\n1. Older than 70 years old or because of chemotherapy surgery and complications after intolerance;\n2. The vagus nerve invasion or invasion of adjacent organs or confirmed the presence of distant metastasis;\n3. Have a history of abdominal surgery or chemotherapy before surgery;\n4. The recent cardiovascular hemorrhagic or ischemic disease;\n5. The amount of abnormal glucose tolerance or diabetes;\n6. Not suitable for robotic surgery, such as body short that mechanical arm can not have enough activity range;\n7. The history of biliary calculi or gastrointestinal dysfunction;\n8. The other is not suitable for receiving robot surgery;\n9. Participated in other clinical studies in the last month;\n10. Other researchers not suitable for participation in the study of (HIV infection and intravenous drug addict), or other effects of this clinical study results analysis of the situation.'}, 'identificationModule': {'nctId': 'NCT02806661', 'briefTitle': 'Comparison of Vagus Nerve-preserving RADG and Conventional RADG for AGC', 'organization': {'class': 'OTHER', 'fullName': 'Southwest Hospital, China'}, 'officialTitle': 'Comparison of Vagus Nerve-preserving Robot-assisted Distal Gastrectomy (RADG) and Conventional Robot-assisted Distal Gastrectomy for Advanced Gastric Cancer (AGC)', 'orgStudyIdInfo': {'id': 'RADG160416'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VPRDG for AGC', 'description': 'Vagus nerve-preserving Robot-assisted distal subtotal gastrectomy (VPRDG) with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.', 'interventionNames': ['Procedure: Vagus nerve-preserving Robot-assisted Gastrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CRDG FOR AGC', 'description': 'Conventional Robot-assisted distal subtotal gastrectomy (CRDG) with D2 lymphadenectomy without preserving vagus nerve will be performed for the treatment of patients assigned to this group.', 'interventionNames': ['Procedure: Conventional Robot-assisted Gastrectomy']}], 'interventions': [{'name': 'Vagus nerve-preserving Robot-assisted Gastrectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['VPRDG for AGC']}, {'name': 'Conventional Robot-assisted Gastrectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['CRDG FOR AGC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400038', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Southwest Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Yingxue Hao, M.D.', 'role': 'CONTACT', 'email': 'haoyingxue@hotmail.com', 'phone': '086-2368754167'}], 'overallOfficials': [{'name': 'Yingxue Hao, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southwest Hospital, Third Military Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Yes, the investigators can share the data with other.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yingxue Hao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yingxue Hao', 'investigatorAffiliation': 'Southwest Hospital, China'}}}}