Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-02-24 @ 2:07 PM
Study NCT ID:
NCT04153058
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2019-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of Robotic Versus Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III AEG
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': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-04', 'studyFirstSubmitDate': '2019-10-20', 'studyFirstSubmitQcDate': '2019-11-03', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year disease free survival rate', 'timeFrame': '36 months', 'description': '3-year disease free survival rate'}], 'secondaryOutcomes': [{'measure': '3-year overall survival rate', 'timeFrame': '36 months', 'description': '3-year overall survival rate'}, {'measure': '3-year recurrence pattern', 'timeFrame': '36 months', 'description': '3-year recurrence pattern'}, {'measure': 'overall postoperative morbidity rates', 'timeFrame': '30 days', 'description': 'overall postoperative morbidity rates'}, {'measure': 'intraoperative morbidity rates', 'timeFrame': '1 day', 'description': 'intraoperative morbidity rates'}, {'measure': 'overall postoperative serious morbidity rates', 'timeFrame': '30 days', 'description': 'overall postoperative serious morbidity rates'}, {'measure': 'number of retrieved lymph nodes', 'timeFrame': '14 days', 'description': 'number of retrieved lymph nodes'}, {'measure': 'Time to first ambulation', 'timeFrame': '30 days', 'description': 'Time to first ambulation is used to access the postoperative recovery course.'}, {'measure': 'Time to first flatus', 'timeFrame': '30 days', 'description': 'Time to first flatus is used to access the postoperative recovery course.'}, {'measure': 'Time to first liquid diet', 'timeFrame': '30 days', 'description': 'Time to first liquid diet is used to access the postoperative recovery course.'}, {'measure': 'Time to soft diet', 'timeFrame': '30 days', 'description': 'Time to soft diet is used to access the postoperative recovery course.'}, {'measure': 'Duration of hospital stay', 'timeFrame': '30 days', 'description': 'Duration of hospital stay is used to access the postoperative recovery course.'}, {'measure': 'The amount of abdominal drainageare', 'timeFrame': '30 days', 'description': 'The amount of abdominal drainageare is used to access the postoperative recovery course.'}, {'measure': 'postoperative nutritional status', 'timeFrame': '3, 6, 9 and 12 months', 'description': 'Weight and height will be combined to report BMI in kg/m\\^2. The variation of BMI in kg/m\\^2 on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.'}, {'measure': 'Hospitalization costs', 'timeFrame': '30 days', 'description': 'Hospitalization costs'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophagogastric Junction Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the clinical outcomes of the robotic assisted radical gastrectomy for advanced Siewert II/III esophagogastric junction adenocarcinoma（cT2-4a, N-/+, M0）', 'detailedDescription': "In recent years, the incidence of gastric cancer has been decreasing year by year in the world, but the incidence of adenocarcinoma of the esophagogastric junction (AEG) has shown a significant upward trend, especially in Western countries such as Europe and the United States. The prognosis of AEG is poor, therefore, it is extremely necessary to establish AEG's best diagnosis and treatment strategies to improve the long-term outcome of AEG. Robotic surgery has been developed with the aim of improving surgical quality and overcoming the limitations of conventional laparoscopy in the performance of complex mini-invasive procedures. The study is designed to explore the clinical outcomes of the robotic assisted radical gastrectomy for advanced Siewert II/III esophagogastric junction adenocarcinoma (cT2-4a, N-/+, M0) by comparing with laparoscopic assisted."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from over 18 to under 75 years\n* Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy\n* cT2-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition\n* Expected to perform total gastrectomy with D2+No.19+No.20 lymph node dissction to obtain R0 resection sugicall results.\n* Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale\n* ASA (American Society of Anesthesiology) class I to III\n* Written informed consent\n\nExclusion Criteria:\n\n* Women during pregnancy or breast-feeding\n* Severe mental disorder\n* History of previous upper abdominal surgery (except laparoscopic cholecystectomy)\n* History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)\n* Gastric multiple primary carcinoma\n* Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging\n* History of other malignant disease within the past 5 years\n* History of previous neoadjuvant chemotherapy or radiotherapy\n* History of unstable angina or myocardial infarction within the past 6 months\n* History of cerebrovascular accident within the past 6 months\n* History of continuous systematic administration of corticosteroids within 1 month\n* Requirement of simultaneous surgery for other disease\n* Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer\n* FEV1\\<50% of the predicted values'}, 'identificationModule': {'nctId': 'NCT04153058', 'briefTitle': 'Clinical Outcomes of Robotic Versus Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III AEG', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Medical University'}, 'officialTitle': 'Randomized Controlled Trials on Clinical Outcomes of Robotic Versus Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma', 'orgStudyIdInfo': {'id': 'FUGES-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robotic Assisted AEG Radical Gastrectomy', 'description': 'Robotic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma', 'interventionNames': ['Procedure: Robotic Assisted AEG Radical Gastrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopic Assisted AEG Radical Gastrectomy', 'description': 'Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma', 'interventionNames': ['Procedure: Laparoscopic Assisted AEG Radical Gastrectomy']}], 'interventions': [{'name': 'Robotic Assisted AEG Radical Gastrectomy', 'type': 'PROCEDURE', 'description': 'Robotic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma', 'armGroupLabels': ['Robotic Assisted AEG Radical Gastrectomy']}, {'name': 'Laparoscopic Assisted AEG Radical Gastrectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma', 'armGroupLabels': ['Laparoscopic Assisted AEG Radical Gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350001', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian Medical University Union Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'overallOfficials': [{'name': 'Chang-Ming Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fujian Medical University Union Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chang-Ming Huang, Prof.', 'investigatorAffiliation': 'Fujian Medical University'}}}}