the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer
NCT ID: NCT05235932
Last Updated: 2022-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
570 participants
INTERVENTIONAL
2022-02-20
2027-02-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Robotic radical total gastrectomy with D2 lymphadenectomy
After exploration and randomization, patients received robotic radical total gastrectomy with D2 lymphadenectomy
Robotic radical total gastrectomy with D2 lymphadenectomy
Most surgical procedures are performed using the robot system.
Laparoscopic radical total gastrectomy with D2 lymphadenectomy
After exploration and randomization, patients received laparoscopic radical total gastrectomy with D2 lymphadenectomy
Laparoscopic radical total gastrectomy with D2 lymphadenectomy
Without the robot system, Most surgical procedures are performed using laparoscopic equipment.
Interventions
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Robotic radical total gastrectomy with D2 lymphadenectomy
Most surgical procedures are performed using the robot system.
Laparoscopic radical total gastrectomy with D2 lymphadenectomy
Without the robot system, Most surgical procedures are performed using laparoscopic equipment.
Eligibility Criteria
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Inclusion Criteria
3.Preoperative clinical stages were CT2-4A、 N-/+、and M0 (according to AJCC-8th TNM tumor staging) 4.Excepting to perform radical total gastrectomy and D2 lymph node dissection can achieve R0 resection.
5.American Society of Anesthesiology (ASA) score class I, II, or III 6.Written informed consent
Exclusion Criteria
2. Women during pregnancy or breast-feeding
3. Severe mental disorder
4. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
5. History of previous gastrectomy(except for ESD/EMR for gastric cancer )
6. Enlarged or bulky regional lymph node over 3 cm by preoperative imaging
7. History of other malignant disease within the past five years
8. History of previous neoadjuvant chemotherapy or radiotherapy
9. History of unstable angina or myocardial infarction within past six months
10. History of cerebrovascular accident within past six months
11. History of continuous systematic administration of corticosteroids within one month
12. Requirement for simultaneous surgery for other disease(except laparoscopic cholecystectomy)
13. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
14. FEV1 (forced expiratory volume in one second)\<50% of predicted values
18 Years
75 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
Lanzhou Military Region General Hospital
UNKNOWN
Gansu Provincial Hospital
OTHER
Southwest Hospital, China
OTHER
First Affiliated Hospital of Guangxi Medical University
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Second Xiangya Hospital of Central South University
OTHER
Hebei Medical University Fourth Hospital
OTHER
The Affiliated Hospital of Qingdao University
OTHER
The Second Affiliated Hospital of Dalian Medical University
OTHER
Fujian Medical University
OTHER
Responsible Party
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Chang-Ming Huang, Prof.
Professor
Principal Investigators
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Chang-ming Huang, MD
Role: STUDY_CHAIR
Fujian Medical University Union Hospital
Locations
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Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Countries
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Central Contacts
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Other Identifiers
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2022-02
Identifier Type: -
Identifier Source: org_study_id
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