Single-arm phase II trial to evaluate safety of laparoscopic total gastrectomy with spleen-preserving splenic hilar dissection for proximal gastric cancer invading the greater curvature(JCOG1809, LTG-SPRING-PII)
Phase 2
Recruiting
- Conditions
- cT2 (MP) - T4a (SE) gastric cancer invading the greater curvature
- Registration Number
- JPRN-UMIN000037580
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 85
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 CT
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of pancreatic fistula and/or abdominal abscess
- Secondary Outcome Measures
Name Time Method Blood loss, operation time, surgery-related death, overall complication, number of removed splenic hilar nodes, number of metastatic splenic hilar nodes, conversion to open surgery, conversion to splenectomy, relapse-free survival, overall survival