NL-OMON24349招募中不适用
A pilot study to assess the safety and feasibility of fluorescent sentinel lymph node identification in colon carcinoma using Indocyanine green.
Meander Medical Centre, Department of Surgery0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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
入排标准
入选标准
- •Oral and written informed consent (IC);
- •- Aged 18 years and older;
- •- Pathologically confirmed and/or suspected T1-T2 colon carcinoma without (suspected) lymph node metastases.
排除标准
- •- Distant metastasis;
- •- cT3- T 4 disease based on pre-operative assessment;
- •- Metastatic or T 4 disease discovered during intraoperative staging;
- •- A tumour too large to pass endoscopically;
- •- Pregnancy, lactation or a planned pregnancy during the course of the study.
- •- Known allergy to any of the compound used for SLN identification (ICG, iodine or sodium iodide);
- •- Suspected or proven lymph node metastasis;
- •- Previous colon surgery;
- •- Contra-indication for robotic surgery;
- •- Ink marking close to the tumour;
- •- Severe kidney- or liver failure;
- •- Hyperthyroidism or an autonomously functioning thyroid adenoma.
研究者
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