Clinical Trials in China / NCT04795063
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Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer
NCT04795063 · tracked via the Priya Life Science China tracker
Condition(s) studied
Gastric CancerRobotic Gastrectomy
Investigational drug(s) / intervention(s)
Total Robotic Distal GastrectomyRobotic-Assisted Distal Gastrectomy
Total Robotic Distal Gastrectomy: All the surgical procedures are performed using the robot system.
Robotic-Assisted Distal Gastrectomy: After finishing the lymphadenectomy, the digestive tract reconstruction is performed extracorporal.
Study 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).
Eligibility
Inclusion Criteria:
1. Age from over 18 to under 75 years
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
3. cT1-4a (clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
4. expected to perform distal gastrectomy with D1+/D2 lymph node dissection to obtain R0 resection surgicall results.
5. Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
6. American Society of Anesthesiology (ASA) class I to III
7. Written informed consent
Exclusion Criteria:
1. Women during pregnancy or breast-feeding
2. Severe mental disorder
3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
4. History of previous gastric surgery (except Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection (ESD/EMR) for gastric cancer)
5. Gastric multiple primary carcinoma
6. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
7. History of other malignant disease within the past 5 years
8. History of previous neoadjuvant chemotherapy or radiotherapy
9. History of unstable angina or myocardial infarction within the past 6 months
10. History of cerebrovascular accident within the past 6 months
11. History of continuous systematic administration of corticosteroids within 1 month
12. Requirement of simultaneous surgery for other disease
13. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
14. Forced expiratory volume in 1 second (FEV1)\<50% of the predicted values
Primary outcome measure(s)
- Morbidity rates — 30 days
This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian |
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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 NCT04795063 on ClinicalTrials.gov ↗ ← All trials in China