Randomized controlled phase III trial to investigate superiority of robot-assisted gastrectomy over laparoscopic gastrectomy for clinical stage T1-4aN0-3 Gastric Cancer patients (JCOG1907, MONA LISA study)
Phase 3
Recruiting
- Conditions
- clinical stage T1-4aN0-3 Gastric Cancer
- Registration Number
- JPRN-UMIN000039825
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1040
Inclusion Criteria
Not provided
Exclusion Criteria
1) Synchronous or metachronous (within 5 years) malignancies. 2) Infectious disease requiring systemic treatment. 3) Body temperature of 38 degrees Celsius or higher. 4) During pregnancy, within 28 days postpartum, or during lactation. 5) Severe mental disease. 6) Receiving continuous systemic corticosteroid or immunosuppressant treatment. 7) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration. 8) Poorly controlled valve disease, dilated or hypertrophic cardiomyopathy 9) HIV antibody positive 10) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema based on chest computed tomography
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of postoperative intra-abdominal infectious complications including leakage, pancreatic fistula, and abdominal abscess with Clavien-Dindo grade II and more
- Secondary Outcome Measures
Name Time Method Incidence of postoperative complications with Clavien-Dindo grade II and more, incidence of postoperative complications with Clavien-Dindo grade IIIA and more, incidence of postoperative intra-abdominal infectious complications with Clavien-Dindo grade IIIA and more, relapse-free survival, overall survival, proportion of robot-assisted gastrectomy completion, proportion of laparoscopic gastrectomy completion, proportion of conversion to open surgery, proportion of surgery-related death, short-term clinical outcomes after gastrectomy