Clinical trial · Observational
Detection of Ileoanal Pouch/Reservoir Adenomas
Detection of Ileoanal Pouch/ Reservoir Adenomas by Routine Chromoendoscopy With Indigocarmine
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomatous Polyps | Adenomatous Polyp | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adenomas detection rate with the different observation methods | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ileoanal pouch adenomas detection assessment
- description
- 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.
- interventionNames
- Procedure: Adenomas detection rate with the different observation methods
Primary outcomes (1)
- measure
- Average number of ileal pouch/reservoir adenomas
- timeFrame
- 6 months after colonoscopy
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available