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Clinical Trials in China / NCT04795063
Starting soon Not applicable

Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer

NCT04795063 · tracked via the Priya Life Science China tracker
Sponsor
Fujian Medical University
Phase
Not applicable
Started
2021-03-01
Last updated
2021-03-12

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

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

Trial sites (1)

FacilityCityRegionStatus
Fujian Medical University Union Hospital Fuzhou Fujian

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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 NCT04795063 on ClinicalTrials.gov ↗ ← All trials in China