A phase II study of laparoscopy assisted distal gastrectomy with nodal dissection for clinical stage I gastric cancer (JCOG0703)
Phase 2
- Conditions
- clinical stage I gastric cancer
- Registration Number
- JPRN-UMIN000000874
- Lead Sponsor
- Japan Clinical Oncology Group(JCOG)
- Brief Summary
See the datails via "URL releasing results" above. Also the details can be seen in the JCOG website: http://www.jcog.jp/en/trials/index.html
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 170
Inclusion Criteria
Not provided
Exclusion Criteria
1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ. 2) Women during pregnancy or breast-feeding. 3) Severe mental disease. 4) Continuous systemic steroid therapy. 5) History of myocardial infarction or unstable angina pectoris within six months. 6) Uncontrollable hypertension. 7) Uncontrollable diabetes millutus or administration of insulin. 8) Severe respiratory disease requiring continuous oxygen therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of anastomotic leakage or pancreatic fistula
- Secondary Outcome Measures
Name Time Method overall survival, recurrence-free survival, proportion of LADG completion, proportion of conversion to open surgery, adverse events, short-term clinical outcomes