跳至主要内容
临床试验/NCT05805020
NCT05805020招募中不适用

Is There a Concordance Between the Cellvizio With an Intravenous Injection of Fluorescein and the Pathology to Determine the Microscopic Inflammation at the Ileal Resection Margins in Crohn's Ileal Disease

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2022年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
41
试验地点
1
主要终点
concordance between the Cellvizio pictures and the pathology incidence

研究概览

简要总结

Crohn disease is an inflammatory bowel disease. A surgical procedure is required in about 80% of cases. Surgery doesn't cure from Crohn's disease but the type of surgery remains important as there are several intraoperative risk factors for recurrence. Among these factors the microscopic inflammation at the resection margins. This is a crucial point, if the resection is too large there is a risk of short bowel syndrome, if the resection is too short (microscopic inflammation at resection site), there is a higher risk of postoperative recurrence (75% vs 46% at 18 months). Surgeons have to do a limited resection (2cm from macroscopic crohn disease). However this macroscopic non inflammatory resection margin can be microscopically inflammatory (up to 80%). Thus it is useful to evaluate if there is a microscopic inflammation at the resection margin. Moreover there is an increase interest for the role of the mesentery for recurrence but its role remains unclear. It is of interest to clarify the border between the inflammatory and non-inflammatory mesentery. Cellvizio is a confocal laser endomicroscopy providing the possibility of obtaining in vivo high-magnification images of the gut epithelium. This allows real-time examination of the gastrointestinal mucosa at the cellular and subcellular level. Cellvizio has never been used during surgery for Crohn disease.

The aim of this study is to evaluate the intraoperative use of Cellvizio (using the CelioFlex microsonde) with an intravenous injection of fluorescein to determine the best ileal resection margins in Crohn disease.

研究设计

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

  • Patients who need a ileocaecal resection for a Crohn disease whatever is the phenotype of the Crohn's disease

排除标准

  • Patients<18 years old,
  • pregnancy or breastfeeding,
  • patients who have an ileocolic resection for a surgical recurrence of the Crohn's disease.
  • Patients operated in emergency for a peritonitis,
  • patients who have a contra-indication for fluorescein injection or severe allergia to any drug

结局指标

主要结局

concordance between the Cellvizio pictures and the pathology incidence

时间窗: 2 years

concordance between the Cellvizio pictures and the pathology for microscopic inflammation at the ileal resection margin.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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