Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-24 @ 1:49 PM
Study NCT ID:
NCT04164095
Status:
NOT_YET_RECRUITING
Last Update Posted:
2019-12-05
First Post:
2019-11-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multicenter Randomized Controlled Study of the Effect of Laparoscopic Preservation of the Pylorus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-03', 'studyFirstSubmitDate': '2019-11-12', 'studyFirstSubmitQcDate': '2019-11-12', 'lastUpdatePostDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EORTC-QLQ-C30', 'timeFrame': '5 years', 'description': 'score: 0-100. more global and functional scales is better. less symptom scales is better'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Quality of Life']}, 'descriptionModule': {'briefSummary': 'For the patients with early gastric cancer (T1), preoperative evaluation (gastroscope, ultrasound gastroscope and abdominal enhanced CT) showed that the tumor was located in the body of the stomach, and the margin was enough to retain the pylorus and non lymph node metastasis (N0). Lappg (D1 + lymph node dissection) and traditional laparoscopic distal gastrectomy (BII type anastomosis, D1 + lymph node dissection) were included A control study was conducted to evaluate the influence of two surgical methods on the long-term quality of life of patients after operation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years old \\< age \\< 75 years old;\n2. primary gastric lesions were diagnosed as gastric adenocarcinoma by biopsy;\n3. the preoperative clinical stage was T1N0M0 according to ajcc-7thtnm;\n4. it is predicted that R0 can be obtained by pylorogastric gastrectomy and D1 + lymph node dissection;\n5. preoperative ECoG physical state score 0 / 1;\n6. preoperative ASA score I-III;\n7. informed consent of patients.\n\nExclusion Criteria:\n\n1. pregnant or lactating women; suffering from serious mental illness;\n2. the history of upper abdominal surgery (except laparoscopic cholecystectomy);\n3. history of gastric surgery (including ESD / EMR for gastric cancer);\n4. preoperative imaging examination showed regional enlarged lymph nodes;\n5. having other malignant diseases within 5 years;\n6. patients with gastric cancer who have received new adjuvant therapy or recommended new adjuvant therapy;\n7. there was a history of unstable angina or myocardial infarction within 6 months;\n8. have a history of cerebral infarction or cerebral hemorrhage within 6 months;\n9. there was a history of continuous systemic corticosteroid therapy within 1 month;\n10. simultaneous surgical treatment of other diseases is needed;\n11. gastric cancer with complications (hemorrhage, perforation, obstruction) requires emergency surgery;\n12. FEV1 of pulmonary function examination was less than 50% of the predicted value.'}, 'identificationModule': {'nctId': 'NCT04164095', 'briefTitle': 'A Multicenter Randomized Controlled Study of the Effect of Laparoscopic Preservation of the Pylorus', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'A Multicenter Randomized Controlled Study of the Effect of Laparoscopic Preservation of the Pylorus and Vagus Nerve on the Postoperative Quality of Life in Patients With Early Gastric Cancer', 'orgStudyIdInfo': {'id': 'LVLM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lappg', 'interventionNames': ['Procedure: lappg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ladgbi', 'interventionNames': ['Procedure: lappg']}], 'interventions': [{'name': 'lappg', 'type': 'PROCEDURE', 'description': 'Preservation of pylorus and vagus nerve by laparoscopy', 'armGroupLabels': ['ladgbi', 'lappg']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Dalian Medical University', 'class': 'OTHER'}, {'name': 'Affiliated Hospital of Qinghai University', 'class': 'OTHER'}, {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Suzhou University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PROFESSOR', 'investigatorFullName': 'zhaogang', 'investigatorAffiliation': 'RenJi Hospital'}}}}