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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04112563
Acronym
COCORICO
Enrollment
686
Registered
2019-10-02
Start date
2020-01-01
Completion date
2022-12-29
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoma Colon, Colonoscopy, Colon Polyp

Brief 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.

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: 1. Patient consecutively admitted to one of the endoscopy units for routine colonoscopy (screening, positive FIT, personal or family history of polyp or cancer, symptoms) 2. Patient whose age is greater than or equal to 18 years and less than 90 years 3. Score: ASA 1, ASA 2, ASA 3 4. No participation in another clinical study 5. 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: 1. History of recto-colonic resection 2. Inadequate preparation (none under Boston score \<2) 3. Patient referred for resection of a known polyp 4. Inflammatory Bowel Disease 5. family polyposis 6. Score: ASA 4, ASA 5 7. Pregnant woman 8. Patient with coagulation abnormalities preventing polyp resection: TP \<50%, Platelets \<50000 / mm3, effective anticoagulation in progress, clopidogrel in progress 9. Patient unable to personally consent 10. 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

Interventions

PROCEDUREexploration in white light (WLI)

Exploration of the right colon done in white light (WLI)

PROCEDUREExploration in LCI

Exploration of the right colon in linked color imaging (LCI)

Sponsors

Société Française d'Endoscopie Digestive
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention 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)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the number of missed adenomas during the first exploration of the right colon1 dayNumber of polyps diagnosed on the second exploration and not removed (because not diagnosed) during the first exploration

Secondary

MeasureTime frameDescription
The factors influencing these missed polyp rates1 dayTime of exploration (in seconds)
The characteristics of the missed polyps1 daySize in millimeters
Adenoma Detection Rate (ADR)1 daygiven by the first exploration technique decided by randomization: percentage of colonoscopy with one or more adenoma of the right colon
Advanced Neoplasia Detection Rate (ANDR)1 daygiven by the first exploration technique decided by randomization: percentage of colonoscopy with one or more advanced neoplasia of the right colon
Serrated Polyp Detection Rate (SPDR)1 daygiven by the first exploration technique decided by randomization: percentage of colonoscopy with one or more serrated polyp of the right colon

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026