Detection of Ileoanal Pouch/Reservoir Adenomas

Trial Title: Detection of Ileoanal Pouch/Reservoir Adenomas

NCT ID: NCT05954949

Condition: Adenomatous Polyps

Conditions: Official terms:
Adenoma
Adenomatous Polyps

Conditions: Keywords:
familial adenomatous polyposis
Ileoanal pouch/reservoir
adenomas
chromoendoscopy
indigocarmine
colectomy

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Procedure
Intervention name: Adenomas detection rate with the different observation methods
Description: 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
Arm group label: Ileoanal pouch adenomas detection assessment

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.

Criteria for eligibility:

Study pop:
Adults with familial adenomatous polyposis after colectomy

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - 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 Exclusion Criteria: - 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

Gender: All

Minimum age: 18 Years

Maximum age: 90 Years

Healthy volunteers: No

Start date: September 9, 2024

Completion date: September 11, 2025

Lead sponsor:
Agency: Jean Christophe Saurin
Agency class: Other

Source: Hôpital Edouard Herriot

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05954949