Adenoma ColonCOCORICONCT04112563
COmparison of White Light and Linked COlor Imaging for Detection of RIght COlon Polyps
A study testing exploration in white light (WLI) and Exploration in LCI in people with Adenoma Colon and Colon Polyp, run by Société Française d'Endoscopie Digestive at 1 site in France.
Trial summary
Comparison of the number of adenomas missed by the first exploration of the right colon by LCI (linked color imaging) or by white light during a colonoscopy, according to the order of randomization. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Adenoma Colon, Colon Polyp, Colonoscopy
- What is being tested?
- exploration in white light (WLI) and Exploration in LCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 686 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 29 Dec 2022
- Phase
- Interventional
- 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
Who may be able to join
- Patient consecutively admitted for routine colonoscopy
Who cannot join
- History of recto-colic resection
- Inadequate preparation (none under Boston score <2)
- Patient referred for resection of a known polyp
- known Inflammatory Bowel Disease (IBD) or known polyposis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COmparison of White Light and Linked COlor Imaging for Detection of RIght COlon Polyps: A Multi Center Prospective Randomized Tandem Colonoscopy Study
Comparison of the number of adenomas missed by the first exploration of the right colon by LCI (linked color imaging) or by white light during a colonoscopy, according to the order of randomization.
Read the detailed description
All patients consecutively admitted for routine colonoscopy will be included in this prospective randomized crossover study. After randomization, a first exploration of the right colon will be performed in linked color imaging (LCI) or white light imaging (WLI) depending of the randomization. Every polyp will be resected as soon it will be detected. After this first examination, colon will be explored a second time with a light system different from the one used for the first exploration. If a polyp will be detected during the second exploration, it will be counted as a polyp missed by the first exploration method.
A- Inclusion criteria:
- Patient consecutively admitted to one of the endoscopy units for routine colonoscopy (screening, positive FIT, personal or family history of polyp or cancer, symptoms)
- Patient whose age is greater than or equal to 18 years and less than 90 years
- Score: ASA 1, ASA 2, ASA 3
- No participation in another clinical study
- Signed informed consent
Exclusion criteria:
History of recto-colic resection Inadequate preparation (none under Boston score <2) Patient referred for resection of a polyp in place, known IBD (inflammatory bowel disease) or known polyposis
B- Exclusion criteria:
- History of recto-colonic resection
- Inadequate preparation (none under Boston score <2)
- Patient referred for resection of a known polyp
- Inflammatory Bowel Disease
- family polyposis
- Score: ASA 4, ASA 5
- Pregnant woman
- Patient with coagulation abnormalities preventing polyp resection: TP <50%, Platelets <50000 / mm3, effective anticoagulation in progress, clopidogrel in progress
- Patient unable to personally consent
- No signed informed consent
Purposes of the study:
Compare, when exploring the number of adenomas missed by the first exploration of the right colon by LCI or by white light, according to the order of randomization.
Evaluation criteria :
Main criterion:
- Missed right colon adenomas by first exploration in LCI-WLI and WLI-LCI groups
Secondary criteria
- Rate of polyps missed by the first exploration
- Serrated polyp rate missed by the first exploration
- Advanced adenoma rate missed by the first exploration
- Comparison of ADR, SPDR, given by the first exploration technique decided by randomization
Number of patients:
The expected rate of "missed adenomas" of the colon is about 20%, based on published data. Considering as relevant an 8% reduction in this rate of "missed adenomas" of the right colon by the LCI, the expected rate for LCI is therefore 12%.
With a risk of the first species of 5% (bilateral test), a power of 80%, 329 patients per group should be included in the study. Taking into account the rate lost to follow-up of 5%, we expect a total of 700 patients.
Duration of the study:
1-2 years
- Conditions
- Adenoma Colon, Colon Polyp, Colonoscopy
- Being tested
- exploration in white light (WLI), Exploration in LCI
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exploration in white light (WLI)Procedure or surgery
Exploration of the right colon done in white light (WLI)
Exploration in LCIProcedure or surgery
Exploration of the right colon in linked color imaging (LCI)
| Study group | Role | What they receive |
|---|---|---|
| WLI-LCI group | Active comparator | a first exploration of the right colon will be done in white light (WLI) then a second exploration will be done in LCI Receives: Procedure: exploration in white light (WLI); Procedure: Exploration in LCI |
| LCI-WLI group | Active comparator | a first exploration of the right colon will be done in LCI and a second exploration will be done in white light (WLI) Receives: Procedure: exploration in white light (WLI); Procedure: Exploration in LCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of missed adenomas during the first exploration of the right colon
Number of polyps diagnosed on the second exploration and not removed (because not diagnosed) during the first exploration
Measured: 1 day
Secondary outcomes (7)
The factors influencing these missed polyp rates
Time of exploration (in seconds)
Measured: 1 day
The factors influencing these missed polyp rates
Boston scale (0 to 9)
Measured: 1 day
The characteristics of the missed polyps
Size in millimeters
Measured: 1 day
The characteristics of the missed polyps
type : Adenoma polyp / Advanced neoplasia polyp / Serrated polyp / Hyperplastic polyp
Measured: 1 day
Adenoma Detection Rate (ADR)
given by the first exploration technique decided by randomization: percentage of colonoscopy with one or more adenoma of the right colon
Measured: 1 day
Advanced Neoplasia Detection Rate (ANDR)
given by the first exploration technique decided by randomization: percentage of colonoscopy with one or more advanced neoplasia of the right colon
Measured: 1 day
Serrated Polyp Detection Rate (SPDR)
given by the first exploration technique decided by randomization: percentage of colonoscopy with one or more serrated polyp of the right colon
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start1 Jan 2020
- Primary completion22 Dec 2022
- Study completion29 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenoma ColonStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- the patient will be randomized and included in one of two groups: WLI-LCI group: a first exploration of the right colon will be done in white light (WLI) then a second exploration will be done in LCI LCI-WLI group: a first exploration of the right colon will be done in LCI and a second exploration will be done in white light (WLI)
- Masking
- None (open label)
- Enrolment
- 686 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société Française d'Endoscopie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KARSENTI, Société Française d'Endoscopie Digestive
- Investigators
- David KARSENTI, MD, Principal investigator, Société Française d'Endoscopie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112563
- Sponsor's protocol ID
- ID-RCB 2019-A01287-50
- Acronym
- COCORICO
- Status last verified
- Jul 2024
- First submitted
- 29 Sep 2019
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karsenti D, Perrod G, Perrot B, Queneherve L, Chabrun E, Koch S, Vanbiervliet G, Rahmi G, Velut G, Moreno-Garcia M, Cavicchi M, Dray X. Impact of linked color imaging on the proximal adenoma miss rate: a multicenter tandem randomized controlled trial (the COCORICO trial). Endoscopy. 2024 Oct;56(10):759-767. doi: 10.1055/a-2324-8807. Epub 2024 May 13.
PubMed 38740373
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COmparison of White Light and Linked COlor Imaging for Detection of RIght COlon Polyps: A Multi Center Prospective Randomized Tandem Colonoscopy Study
- ClinicalTrials.gov ID
- NCT04112563
- Acronym / sponsor ID
- COCORICO / ID-RCB 2019-A01287-50
- Conditions
- Adenoma Colon, Colon Polyp, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 686 participants (actual)
- Lead sponsor
- Société Française d'Endoscopie DigestiveUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 29 Dec 2022 (actual)
- First posted
- 2 Oct 2019 (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.
Comparison of the number of adenomas missed by the first exploration of the right colon by LCI (linked color imaging) or by white light during a colonoscopy, according to the order of randomization.
Detailed description
All patients consecutively admitted for routine colonoscopy will be included in this prospective randomized crossover study. After randomization, a first exploration of the right colon will be performed in linked color imaging (LCI) or white light imaging (WLI) depending of the randomization. Every polyp will be resected as soon it will be detected. After this first examination, colon will be explored a second time with a light system different from the one used for the first exploration. If a polyp will be detected during the second exploration, it will be counted as a polyp missed by the first exploration method.
A- Inclusion criteria:
- Patient consecutively admitted to one of the endoscopy units for routine colonoscopy (screening, positive FIT, personal or family history of polyp or cancer, symptoms)
- Patient whose age is greater than or equal to 18 years and less than 90 years
- Score: ASA 1, ASA 2, ASA 3
- No participation in another clinical study
- Signed informed consent
Exclusion criteria:
History of recto-colic resection Inadequate preparation (none under Boston score <2) Patient referred for resection of a polyp in place, known IBD (inflammatory bowel disease) or known polyposis
B- Exclusion criteria:
- History of recto-colonic resection
- Inadequate preparation (none under Boston score <2)
- Patient referred for resection of a known polyp
- Inflammatory Bowel Disease
- family polyposis
- Score: ASA 4, ASA 5
- Pregnant woman
- Patient with coagulation abnormalities preventing polyp resection: TP <50%, Platelets <50000 / mm3, effective anticoagulation in progress, clopidogrel in progress
- Patient unable to personally consent
- No signed informed consent
Purposes of the study:
Compare, when exploring the number of adenomas missed by the first exploration of the right colon by LCI or by white light, according to the order of randomization.
Evaluation criteria :
Main criterion:
- Missed right colon adenomas by first exploration in LCI-WLI and WLI-LCI groups
Secondary criteria
- Rate of polyps missed by the first exploration
- Serrated polyp rate missed by the first exploration
- Advanced adenoma rate missed by the first exploration
- Comparison of ADR, SPDR, given by the first exploration technique decided by randomization
Number of patients:
The expected rate of "missed adenomas" of the colon is about 20%, based on published data. Considering as relevant an 8% reduction in this rate of "missed adenomas" of the right colon by the LCI, the expected rate for LCI is therefore 12%.
With a risk of the first species of 5% (bilateral test), a power of 80%, 329 patients per group should be included in the study. Taking into account the rate lost to follow-up of 5%, we expect a total of 700 patients.
Duration of the study:
1-2 years
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the patient will be randomized and included in one of two groups: WLI-LCI group: a first exploration of the right colon will be done in white light (WLI) then a second exploration will be done in LCI LCI-WLI group: a first exploration of the right colon will be done in LCI and a second exploration will be done in white light (WLI)
| Arm | Type | Receives |
|---|---|---|
| WLI-LCI group | Active comparator | Procedure: exploration in white light (WLI), Procedure: Exploration in LCIa first exploration of the right colon will be done in white light (WLI) then a second exploration will be done in LCI |
| LCI-WLI group | Active comparator | Procedure: exploration in white light (WLI), Procedure: Exploration in LCIa first exploration of the right colon will be done in LCI and a second exploration will be done in white light (WLI) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient consecutively admitted for routine colonoscopy
Key exclusion criteria (4 listed)
- History of recto-colic resection
- Inadequate preparation (none under Boston score <2)
- Patient referred for resection of a known polyp
- known Inflammatory Bowel Disease (IBD) or known polyposis
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 |
|---|---|---|
| exploration in white light (WLI)Exploration of the right colon done in white light (WLI) | Procedure or surgery | LCI-WLI group, WLI-LCI group |
| Exploration in LCIExploration of the right colon in linked color imaging (LCI) | Procedure or surgery | LCI-WLI group, WLI-LCI group |
Primary outcome
the number of missed adenomas during the first exploration of the right colon
Time frame: 1 day
Number of polyps diagnosed on the second exploration and not removed (because not diagnosed) during the first exploration
7 secondary outcomes
The factors influencing these missed polyp rates
Time frame: 1 day
The factors influencing these missed polyp rates
Time frame: 1 day
The characteristics of the missed polyps
Time frame: 1 day
The characteristics of the missed polyps
Time frame: 1 day
Adenoma Detection Rate (ADR)
Time frame: 1 day
Advanced Neoplasia Detection Rate (ANDR)
Time frame: 1 day
Serrated Polyp Detection Rate (SPDR)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 38740373Karsenti D, Perrod G, Perrot B, Queneherve L, Chabrun E, Koch S, Vanbiervliet G, Rahmi G, Velut G, Moreno-Garcia M, Cavicchi M, Dray X. Impact of linked color imaging on the proximal adenoma miss rate: a multicenter tandem randomized controlled trial (the COCORICO trial). Endoscopy. 2024 Oct;56(10):759-767. doi: 10.1055/a-2324-8807. Epub 2024 May 13.
- Individual participant dataSharing planned: No
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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.
David KARSENTI, MD principal investigator
Société Française d'Endoscopie Digestive
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exploration in white light (WLI) and Exploration in LCI in people with Adenoma Colon and Colon Polyp, run by Société Française d'Endoscopie Digestive at 1 site in France.
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 1 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: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of missed adenomas during the first exploration of the right colon (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04112563, which also lists 1 linked publication.
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 30 Jul 2024.