Adenomatous PolypsDARIACNCT05954949
Detection of Ileoanal Pouch/Reservoir Adenomas
An observational study of Adenomatous Polyps, run by Jean Christophe Saurin.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Adenomatous Polyps
- What is being tested?
- Adenomas detection rate with the different observation methods
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 9 Sep 2024to 11 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with familial adenomatous polyposis after colectomy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Detection of Ileoanal Pouch/ Reservoir Adenomas by Routine Chromoendoscopy With Indigocarmine
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
- Being tested
- Adenomas detection rate with the different observation methods
- Keywords
- familial adenomatous polyposis, Ileoanal pouch/reservoir, adenomas, chromoendoscopy, indigocarmine, colectomy
- Medical subject headings
- Adenomatous Polyps, Adenomatous Polyposis Coli, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenomas detection rate with the different observation methodsProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Adenomas detection rate with the different observation methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start9 Sep 2024 (estimated)
- Primary completion10 Sep 2025 (estimated)
- Study completion11 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenomatous PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jean Christophe Saurin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jean Christophe Saurin, Hôpital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954949
- Sponsor's protocol ID
- SFED 160
- Acronym
- DARIAC
- Status last verified
- Sep 2023
- First submitted
- 11 Jul 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Ileoanal Pouch/ Reservoir Adenomas by Routine Chromoendoscopy With Indigocarmine
- ClinicalTrials.gov ID
- NCT05954949
- Acronym / sponsor ID
- DARIAC / SFED 160
- Conditions
- Adenomatous Polyps
- Keywords
- familial adenomatous polyposis, Ileoanal pouch/reservoir, adenomas, chromoendoscopy, indigocarmine, colectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jean Christophe SaurinUniversity, hospital or other
- Study start
- 9 Sep 2024 (estimated)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 11 Sep 2025 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ileoanal pouch adenomas detection assessment | – | Procedure: Adenomas detection rate with the different observation methodsEvery 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with familial adenomatous polyposis after colectomy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adenomas detection rate with the different observation methodsFilms 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 | Procedure or surgery | Ileoanal pouch adenomas detection assessment |
Primary outcome
Average number of ileal pouch/reservoir adenomas
Time frame: 6 months after colonoscopy
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenomatous Polyps, run by Jean Christophe Saurin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Christophe SAURIN, Pr (+33 (0)4 72 11 75 72, jean-christophe.saurin@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average number of ileal pouch/reservoir adenomas (time frame: 6 months after colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.