Detection of Ileoanal Pouch/Reservoir Adenomas

NCT ID: NCT05954949

Last Updated: 2023-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-09

Study Completion Date

2025-09-11

Brief Summary

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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

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Conditions

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Adenomatous Polyps

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Ileoanal pouch adenomas detection assessment

Every patient who needs follow up lower digestive examination for familial adenomatous polyposis after colectomy can join this study with ileal pouch adenomas detection by experienced endoscopist.

Adenomas detection rate with the different observation methods

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jean Christophe Saurin

OTHER

Sponsor Role lead

Responsible Party

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Jean Christophe Saurin

Principal Investigator, Medical Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Jean-Christophe SAURIN, Pr

Role: CONTACT

+33 (0)4 72 11 75 72

Maira MORENO, PhD

Role: CONTACT

+33 (0)4 72 11 75 13

Other Identifiers

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SFED 160

Identifier Type: -

Identifier Source: org_study_id

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