跳至主要内容
临床试验/JPRN-UMIN000000476
JPRN-UMIN000000476已完成未知

Multi-center clinical trial for diagnostic value of sentinel node biopsy to detect lymph node metastasis in gastric cancer - Sentinel biopsy for gastric cancer

Japanese Society for sentinel node navigation surgery0 个研究点目标入组 500 人开始时间: 2006年9月1日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
500

研究概览

简要总结

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)

研究设计

研究类型
Interventional

入排标准

年龄范围
ot applicable 至 ot applicable(—)
性别
All

入选标准

  • 未提供

排除标准

  • Pregnancy Drug allergy Asthma

研究者

发起方
Japanese Society for sentinel node navigation surgery

相似试验