EUCTR2019-003179-20-NL进行中（未招募）1 期
‘A pilot study to assess the safety and feasibility of fluorescent sentinel lymph node identification in colon carcinoma using Indocyanine green’ - FLUOR–ICG–SLN(pilot)
Meander Medical Centre0 个研究点目标入组 10 人开始时间: 2020年3月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Oral and written informed consent (IC)
- •- Aged 18 years and older
- •- Pathologically confirmed and/or suspected colon carcinoma
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- Distant metastases
- •- Suspicion of T3-T4 disease based on pre-operative assessment.
- •- Metastatic or T4 disease discovered during intraoperative staging
- •- A tumour too large to pass endoscopically
- •- Pregnant patients
- •- Known allergy to any of the compound used for SLN identification (ICG, Iodine)
- •- Suspected or proven lymph node metastasis
- •- Previous colon surgery
- •- Contra-indication for robotic surgery
- •- Ink marking close to the tumour
研究者
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