Detection of Ileoanal Pouch/ Reservoir Adenomas by Routine Chromoendoscopy With Indigocarmine
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
- 否
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
Jean Christophe Saurin
Principal Investigator, Medical Doctor
Hôpital Edouard Herriot
