In Vivo Study to Determine the Efficacy of Sentinel Node Mapping in Patients With Colon Carcinoma Using Near-infrared Laparoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Number of fluorescent lymph nodes
研究概览
简要总结
The sentinel lymph node (SLN) procedure is a standard staging technique in several types of cancer. One of the major problems of SLN mapping in colorectal cancer is the lack of an optimal dye and technique for identification of the nodes. In this study the investigators used the Near-Infrared (NIR) dye Indocyanin Green (ICG) to identify nodes with a newly developed NIR laparoscope. The investigators compared two different injection techniques; subserosal and submucosal injection.
Patients planned for a laparoscopic resection of a colorectal carcinoma without distant metastases were included. Dye was injected in the subserosa or submucosa of the bowel. Ten minutes after injection the investigators searched for fluorescent nodes with the NIR laparoscope. Fluorescent nodes were harvested and analyzed by the pathologist using H&E and additional immunohistochemistry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Oral and written Informed Consent (IC)
- •Age 18 years and older
- •Patients histological or radiological suspicion of colon cancer
- •Surgical resection of the tumor
- •Regular Pre-operative work-up
排除标准
- •Gross lymph node involvement
- •Distant metastases
- •Advanced disease with invasion of adjacent structures
- •Prior colorectal surgery
- •Metastatic or T4 disease discovered during intraoperative staging
- •Contraindications to laparoscopy
- •Rectal cancer
- •Allergy to iodine
- •Patients at higher risk for anaphylactic reactions
研究组 & 干预措施
SLN identification with NIR-dye-subserosa injection
Near-Infrared (NIR) dye Indocyanin Green (ICG) to identify nodes with a newly developed NIR laparoscope. The investigators compared two different injection techniques; subserosal and submucosal injection.
干预措施: Near-Infrared (NIR) dye Indocyanin Green (ICG) (Procedure)
SLN identification with NIR-dye-submucosal injection
Near-Infrared (NIR) dye Indocyanin Green (ICG) to identify nodes with a newly developed NIR laparoscope. The investigators compared two different injection techniques; subserosal and submucosal injection.
干预措施: Near-Infrared (NIR) dye Indocyanin Green (ICG) (Procedure)
结局指标
主要结局
Number of fluorescent lymph nodes
时间窗: 4 hours
次要结局
- Number of Lymph nodes with metastasis(4 hours)
研究者
M.Ankersmit
MD
Amsterdam UMC, location VUmc