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Clinical Trials in China / NCT05235932
Starting soon Not applicable

the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer

NCT05235932 · tracked via the Priya Life Science China tracker
Sponsor
Fujian Medical University
Phase
Not applicable
Started
2022-02-20
Last updated
2022-02-11

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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)

Trial sites (1)

FacilityCityRegionStatus
Fujian Medical University Union Hospital Fuzhou Fujian

More Fujian Medical University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05235932 on ClinicalTrials.gov ↗ ← All trials in China