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Detection of Ileoanal Pouch/Reservoir Adenomas

NCT05954949 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2023-09-25

No results posted yet for this study

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

  • Adenomatous Polyps

Interventions

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

Sponsors & Collaborators

  • Jean Christophe Saurin

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-09
Primary Completion
2025-09-10
Completion
2025-09-11

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05954949 on ClinicalTrials.gov