Detection of Ileoanal Pouch/Reservoir Adenomas

Not yet recruiting

• Conditions: Adenomatous Polyps

• Registration Number: NCT05954949
• Lead Sponsor: Jean Christophe Saurin

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-11
• Study First Submitted QC: 2023-07-11
• Study First Posted: 2023-07-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-25
• Study Start: 2024-09-09
• Primary Completion: 2025-09-10
• Study Completion: 2025-09-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average number of ileal pouch/reservoir adenomas	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