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the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer
Condition(s) studied
Gastric CancerRobotic Gastrectomy
Investigational drug(s) / intervention(s)
Robotic radical total gastrectomy with D2 lymphadenectomyLaparoscopic 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: Without the robot system, Most surgical procedures are performed using laparoscopic equipment.
Study summary
To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of robotic radical total gastrectomy and laparoscopic radical total gastrectomy in patients with locally advanced middle and upper gastric adenocarcinoma (CT2-4A, N-/+, M0) .
Eligibility
Inclusion Criteria:
* 1.Age between 18 and 75 years 2.The primary gastric lesion was histopathologically diagnosed as middle and upper gastric adenocarcinoma (papillary adenocarcinoma PAP, tubular adenocarcinoma TUB, mucinous adenocarcinoma MUC, signed-ring cell carcinoma SIG, poorly differentiated adenocarcinoma POR) by endoscopic biopsy.
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:
1. Preoperative examination suggested disease staging cT1, N-/+, and M0 (according to AJCC-8th TNM tumor staging )
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
Primary outcome measure(s)
- 3-year disease free survival rate — 36 months
3-year disease free survival rate
Trial sites (1)
| Facility | City | Region | Status |
| Fujian Medical University Union Hospital |
Fuzhou |
Fujian |
|
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