Status:
NOT_YET_RECRUITING
the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer
Lead Sponsor:
Fujian Medical University
Collaborating Sponsors:
Chinese PLA General Hospital
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Gastric Cancer
Robotic Gastrectomy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 ...
Detailed Description
In the field of gastrectomy, Hashizume et al. first reported robotic gastrectomy in 2002. Since then, reports on the safety and feasibility of the application of robotic surgical system in the treatme...
Eligibility Criteria
Inclusion
- 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.
- 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.
- American Society of Anesthesiology (ASA) score class I, II, or III 6.Written informed consent
Exclusion
- Preoperative examination suggested disease staging cT1, N-/+, and M0 (according to AJCC-8th TNM tumor staging )
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy(except for ESD/EMR for gastric cancer )
- Enlarged or bulky regional lymph node over 3 cm by preoperative imaging
- History of other malignant disease within the past five years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement for simultaneous surgery for other disease(except laparoscopic cholecystectomy)
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1 (forced expiratory volume in one second)\<50% of predicted values
Key Trial Info
Start Date :
February 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 20 2027
Estimated Enrollment :
570 Patients enrolled
Trial Details
Trial ID
NCT05235932
Start Date
February 20 2022
End Date
February 20 2027
Last Update
February 11 2022
Active Locations (1)
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1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001