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NCT05954949 Clinical Trial

Detection of Ileoanal Pouch/Reservoir Adenomas

Adenomatous Polyps Clinical Trial

— DARIAC  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05954949
Other study ID # SFED 160
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 9, 2024
Est. completion date September 11, 2025

Study information
Verified date September 2023
Source Hôpital Edouard Herriot
Contact Jean-Christophe SAURIN, Pr
Phone +33 (0)4 72 11 75 72
Email jean-christophe.saurin@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date September 11, 2025
Est. primary completion date September 10, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Jean Christophe Saurin

Outcome
Type Measure Description Time frame Safety issue
Primary Average number of ileal pouch/reservoir adenomas 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 6 months after colonoscopy
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