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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Adenomas detection rate with the different observation methods | Films 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.