Clinical Trials Directory

Trials / Unknown

UnknownNCT05954949

Detection of Ileoanal Pouch/Reservoir Adenomas

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

Status
Unknown
Phase
Study type
Observational
Enrollment
40 (estimated)
Sponsor
Jean Christophe Saurin · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREAdenomas detection rate with the different observation methodsFilms performed in white light high definition, NBI and indigo-carmine dye, will be compared blindly to detecte number of adenomas with the different observation methods

Timeline

Start date
2024-09-09
Primary completion
2025-09-10
Completion
2025-09-11
First posted
2023-07-20
Last updated
2023-09-25

Source: ClinicalTrials.gov record NCT05954949. Inclusion in this directory is not an endorsement.