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

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.

Study Overview

• Status: Recruiting
• Conditions: Colonoscopy; Colon Polyp; Adenoma Colon
• Intervention / Treatment: Procedure: exploration in white light (WLI); Procedure: Exploration in LCI

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

• Study Type: Interventional
• Enrollment (Anticipated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David KARSENTI, MD; Phone Number: +33 1 45 48 65 65; Email: karsenti@club-internet.fr
• Study Contact Backup: Name: Maira MORENO-GARCIA; Email: maira.moreno-garcia@chu-lyon.fr

Study Locations

• France
  • Charenton-le-Pont, France, 94220
    • Recruiting
    • Clinique PARIS-BERCY
    • Contact: David KARSENTI, MD; Phone Number: +33143967850; Email: karsenti@club-internet.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: exploration in white light (WLI); Exploration of the right colon done in white light (WLI); Procedure: Exploration in LCI; Exploration of the right colon in linked color imaging (LCI)
Active Comparator: 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)	Procedure: exploration in white light (WLI); Exploration of the right colon done in white light (WLI); Procedure: Exploration in LCI; Exploration of the right colon in linked color imaging (LCI)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Société Française d'Endoscopie Digestive
• Investigators: Principal Investigator: David KARSENTI, MD, Société Française d'Endoscopie Digestive

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: September 29, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Intestinal Polyps; Adenoma; Polyps; Colonic Polyps
• Other Study ID Numbers: ID-RCB 2019-A01287-50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No