Detection of Ileoanal Pouch/Reservoir Adenomas
DARIAC
Detection of Ileoanal Pouch/ Reservoir Adenomas by Routine Chromoendoscopy With Indigocarmine
1 other identifier
observational
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2024
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2023
CompletedFirst Posted
Study publicly available on registry
July 20, 2023
CompletedStudy Start
First participant enrolled
September 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2025
CompletedSeptember 25, 2023
September 1, 2023
1 year
July 11, 2023
September 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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.
Interventions
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
Eligibility Criteria
Adults with familial adenomatous polyposis after colectomy
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator, Medical Doctor
Study Record Dates
First Submitted
July 11, 2023
First Posted
July 20, 2023
Study Start
September 9, 2024
Primary Completion
September 10, 2025
Study Completion
September 11, 2025
Last Updated
September 25, 2023
Record last verified: 2023-09