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临床试验/NCT03718078
NCT03718078Unknown不适用

Essai Clinique Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d'ExérèsE (PERSÉE) appliquée à la Chirurgie Hépatique

Mauna Kea Technologies2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
malignant pCLE criteria

研究概览

简要总结

This study aims at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during laparoscopic hepatic masses resection for intra-operative characterisation of hepatic masses and surgical margins assessment.

详细描述

Colorectal cancer is the third most common cancer and third leading cause of cancer deaths in the Western countries. In France, 45.000 new patients develop colorectal cancer every year. The liver is the most common organ targeted by CRLM, representing 50%. Approximately, 15-25% of colorectal cancer patients have synchronous CRLM at initial workup, and 20-30% patients sustain subsequent liver metastases within few years following diagnosis.

The strategy for colorectal cancer liver metastasis resection and liver cancer has evolved to a parenchymatic sparing procedure. This technic aims to minimize surgical margins width while removing the tumor. Therefore, the current standard for resection margins is a margin width superior to 1mm. However, there is still a debate concerning the margin width. Indeed, with modern chemotherapy, several studies reported no statistical differences in the overall survival between R0 patients and R1 patients treated with chemotherapy. However, in order to preserve patients from chemotherapy treatments' adverse effects an intra-operative microscopic assessment of surgical margins should be set up in order to reduce R1 margins occurrence.

Ex vivo study:

Surgical specimens obtained during hepatectomy will be imaged to generate an atlas of pCLE images.

In vivo study:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • Over 18 years
  • Scheduled for a surgical resection of hepatic masses
  • Provided signed informed consent

排除标准

  • Allergy to Indocyanine green (ICG)
  • Kidney failure
  • Pregnancy or breastfeeding

研究组 & 干预措施

Confocal Laser Endomicroscopy

Experimental

lt includes patients will undergo probe-based Confocal Laser Endomicroscopy during laparoscopic hepatic masses resection.

干预措施: Confocal Laser Endomicroscopy (Device)

结局指标

主要结局

malignant pCLE criteria

时间窗: 1 year

Definition of pCLE criteria for normal and malignant hepatic tissues

次要结局

  • Audio/video telecommunication quality(1 year)
  • Number of participants with CLE imaging-related adverse events as assessed by CTCAE v5.0(1 year)
  • pathological pCLE criteria(1 year)
  • Ease of use of the endomicroscopy device(1 year)
  • Stability and reproducibility of images/sequences during procedures(1 year)
  • pCLE criteria diagnostic performance(1 year)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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