Pilot Study of Non-exposure Simple Suturing EFTR (NESS-EFTR) With Sentinel Lymph Node Navigation for Early Gastric Cancer (Senorita3-pilot)
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Complete resection
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, NESS) was recently developed.
This is the pilot study to prove the feasibility 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 in differentiated type, less than 2cm in undifferentiated type
- •location: 2cm 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
- •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
This arm will be received non-exposure simple suturing endoscopic full-thickness resection after sentinel lymph node navigation
干预措施: NESS-EFTR (Procedure)
结局指标
主要结局
Complete resection
时间窗: 3 months
single piece resection with clear resection margin
次要结局
未报告次要终点
研究者
Chan Gyoo Kim
Senior scientist
National Cancer Center, Korea