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Detection of Ileoanal Pouch/Reservoir Adenomas

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05954949
Acronym
DARIAC
Enrollment
40
Registered
2023-07-20
Start date
2024-09-09
Completion date
2025-09-11
Last updated
2023-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomatous Polyps

Keywords

familial adenomatous polyposis, Ileoanal pouch/reservoir, adenomas, chromoendoscopy, indigocarmine, colectomy

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.

Interventions

PROCEDUREAdenomas 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

Sponsors

Jean Christophe Saurin
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Average number of ileal pouch/reservoir adenomas6 months after colonoscopyAverage 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

Contacts

Primary ContactJean-Christophe SAURIN, Pr
jean-christophe.saurin@chu-lyon.fr+33 (0)4 72 11 75 72
Backup ContactMaira MORENO, PhD
rechercheclinique@sfed.org+33 (0)4 72 11 75 13

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026