Status:
NOT_YET_RECRUITING
Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer
Lead Sponsor:
Fujian Medical University
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 total robotic versus robotic assisted distal gastrectomy for patients with gastric cancer (cT1-4a, N0/+, M0).
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 from over 18 to under 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT1-4a (clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- expected to perform distal gastrectomy with D1+/D2 lymph node dissection to obtain R0 resection surgicall results.
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
- American Society of Anesthesiology (ASA) class I to III
- Written informed consent
Exclusion
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastric surgery (except Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection (ESD/EMR) for gastric cancer)
- Gastric multiple primary carcinoma
- Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
- History of other malignant disease within the past 5 years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within the past 6 months
- History of cerebrovascular accident within the past 6 months
- History of continuous systematic administration of corticosteroids within 1 month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- Forced expiratory volume in 1 second (FEV1)\<50% of the predicted values
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04795063
Start Date
March 1 2021
End Date
January 1 2027
Last Update
March 12 2021
Active Locations (1)
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1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001