Multi-center clinical trial for diagnostic value of sentinel node biopsy to detect lymph node metastasis in gastric cancer
- Conditions
- Early gastric cancer
- Registration Number
- JPRN-UMIN000000476
- Lead Sponsor
- Japanese Society for sentinel node navigation surgery
- Brief Summary
433 patients enrolled in the study, and 397 were deemed eligible on the basis of surgical findings. SN biopsy was performed in all the patients, and the SN detection rate was 97.5% (393 of 387). Sensitivity to predict lymph node metastasis was 93% (53 of 57), and accuracy of lymph node status based on SN concept was 99% (383 of 387). Only four negative-false cases were observed, and pathological analysis revealed that three of those biopsies were deeper than pT2 or tumors>4cm, and in one of pT1N0 case, SN metastasis was limited within the region of SN basins. We observed no serious adverse events related to endoscopic tracer injection and SN mapping procedure. (J Clin Oncol. 2013: 31:3704-10)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 500
Not provided
Pregnancy Drug allergy Asthma
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity to detect lymph node metastasis based on sentinel node biopsy
- Secondary Outcome Measures
Name Time Method Detection rate of sentinel nodes, The distribution and the number of sentinel nodes Incidence of adverse effect