Indocyanine Green-guided Lymphadenectomy in Laparoscopic Total Mesorectal Excision for Low Rectal Cancer After Neoadjuvant Chemoradiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total number of harvested lymph nodes
研究概览
简要总结
The goal of this clinical trial is to assess the number of harvested locoregional lymph nodes in rectal cancer patients undergoing laparoscopic total mesorectal excision and indocyanine green (ICG)-guided lymphoadenectomy after neoadjuvant chemoradiation. The main questions it aims to answer are:
- Does the use of ICG increase the total number of harvested lymph nodes?
- Does the use of ICG increase the number of harvested extra-mesorectal lymph nodes?
Participants will intraoperatively receive a trans-anal administration of ICG near to rectal cancer; during laparoscopic surgery, ICG-fluorescent nodes beyond the mesorectum will be separately excised and sent for pathology. A comparison will be performed with a recent cohort of patients affected by rectal cancer treated with standard surgery without the use of ICG.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low or middle rectal adenocarcinoma
- •Indication for sphincter-saving surgery
- •Neoadjuvant chemoradiation
- •Indication for laparoscopic surgery
- •Signed informed consent
排除标准
- •Distant metastases at diagnosis, included peritoneal carcinomatosis
- •Squamous cell cancer
- •Allergy to indocyanine green
结局指标
主要结局
Total number of harvested lymph nodes
时间窗: 15 days
Number of harvested extra-mesorectal lymph nodes
时间窗: 15 days
次要结局
- Intraoperative and postoperative complications rates(15 days)
- Time of surgery(15 days)