Non-exposure Simple Suturing Endoscopic Full-Thickness Resection (NESS-EFTR) With Laparoscopic Sentinel Lymph Node Navigation for EGC (Senorita3-phase 2)
试验速览
- 阶段
- 2 期
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- complete resection rate (%) of tumor
研究概览
简要总结
Laparoscopic sentinel lymph node dissection and stomach preserving surgery in early gastric cancer is less invasive method which can increase quality of life. Current stomach preserving surgery after sentinel lymph node dissection produce transmural communication and expose the tumor to the peritoneum during operation. An endoscopic full-thickness resection method with a simple suturing technique that does not expose the gastric mucosa to the peritoneum (non-exposure simple suturing endoscopic full-thickness resection, NESS-EFTR) was recently developed.
This is the phase2 study to identify the efficacy of NESS-EFTR with sentinel node navigation in early gastric cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •single lesion of adenocarcinoma in preoperative endoscopic biopsy
- •clinical stage T1N0 in the preoperative evaluation of endoscopy and computed tomography
- •tumor size: less than 3cm
- •location: 3cm far from the pylorus or cardia
- •aged 20 to 80
- •ECOG 0 or 1
- •patient who signed the agreement
- •patient who is suspected to underwent laparoscopy assisted gastrectomy
排除标准
- •absolute indication of endoscopic submucosal resection
- •inoperable due to poor cardiac, pulmonary function
- •having allergic reaction, previous upper abdominal surgery except laparoscopic cholecystectomy, previous radiation therapy to upper abdomen
- •diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and thyroid cancer
研究组 & 干预措施
NESS-EFTR
Non-exposure Simple Suturing Endoscopic Full-Thickness Resection (NESS-EFTR) With Laparoscopic Sentinel Lymph Node Navigation (basin dissection)
干预措施: NESS-EFTR with sentinel lymph node navigation (Procedure)
结局指标
主要结局
complete resection rate (%) of tumor
时间窗: 2 weeks
the definition of complete resection is 'Tumor exist in single resected piece (en bloc resection) with clear resection margin'.
次要结局
未报告次要终点
研究者
Chan Gyoo Kim
M.D.
National Cancer Center, Korea