COmparison of White Light and Linked COlor Imaging for Detection of RIght COlon Polyps

Study Overview
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Brief Summary
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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
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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

Official Title
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COmparison of White Light and Linked COlor Imaging for Detection of RIght COlon Polyps: A Multi Center Prospective Randomized Tandem Colonoscopy Study

Conditions
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Adenoma Colon, Colon Polyp, Colonoscopy

Intervention / Treatment
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* Procedure: exploration in white light (WLI)
* Procedure: Exploration in LCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient consecutively admitted for routine colonoscopy Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: WLI-LCI group<br>a first exploration of the right colon will be done in white light (WLI) then a second exploration will be done in LCI | Procedure: exploration in white light (WLI)<br>* Exploration of the right colon done in white light (WLI)<br>Procedure: Exploration in LCI<br>* Exploration of the right colon in linked color imaging (LCI)<br>|
| Active Comparator: LCI-WLI group<br>a first exploration of the right colon will be done in LCI and a second exploration will be done in white light (WLI) | Procedure: exploration in white light (WLI)<br>* Exploration of the right colon done in white light (WLI)<br>Procedure: Exploration in LCI<br>* Exploration of the right colon in linked color imaging (LCI)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The factors influencing these missed polyp rates | Time of exploration (in seconds) | 1 day | 
| The factors influencing these missed polyp rates | Boston scale (0 to 9) | 1 day | 
| The characteristics of the missed polyps | Size in millimeters | 1 day | 
| The characteristics of the missed polyps | type : Adenoma polyp / Advanced neoplasia polyp / Serrated polyp / Hyperplastic polyp | 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 | 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 | 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 | 1 day |