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临床试验/NCT05954949
NCT05954949尚未招募不适用

Detection of Ileoanal Pouch/ Reservoir Adenomas by Routine Chromoendoscopy With Indigocarmine

Jean Christophe Saurin0 个研究点目标入组 40 人开始时间: 2024年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
主要终点
Average number of ileal pouch/reservoir adenomas

研究概览

简要总结

The detection of adenomas is the basis for the follow-up of patients with familial adenomatous polyposis, after colectomy, with a remnant rectum or an ileal pouch. The optimal method for the adenomas detection is not defined yet. Despite the proven effectiveness of indigo-carmine in different indications dye chromoendoscopy is not used in a consensual way at the international level. The situation of the ileal pouch is specific as adenomas have a usually flat shape and are much more difficult to identify than in the situation of a remnant rectum, even in the situation of > 5 mm adenomas that should be resected.

Our hypothesis is that indigo-carmine can improve adenomas detection, including > 5 mm adenomas, in patients with a an ileal pouch after colectomy improving the effectiveness of surveillance programs and potentially reducing the risk of cancer in this population.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

入选标准

  • Patients with familial adenomatous polyposis
  • Ileo-anal anastomosis with pouch reservoir
  • Quality of the final preparation = 3 (excellent) on the studied area
  • Films made under optimal conditions for the 3 staining methods

排除标准

  • Patient with no familial adenomatous polyposis
  • Patient without Ileo-anal anastomosis reservoir
  • Insufficient quality of the final preparation <3
  • Absence of films made under optimal conditions for the 3 staining methods

结局指标

主要结局

Average number of ileal pouch/reservoir adenomas

时间窗: 6 months after colonoscopy

Average number of ileal pouch/reservoir adenomas detected according to the endoscopic mode (staining or not, virtual or not) based on a paired review of the films with final consensus in case of discordance

次要结局

未报告次要终点

研究者

发起方
Jean Christophe Saurin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jean Christophe Saurin

Principal Investigator, Medical Doctor

Hôpital Edouard Herriot

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