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

NCT ID: NCT04112563

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 686 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2022-12-29

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

Conditions

Adenoma Colon; Colon Polyp; Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study 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

Group Type: ACTIVE_COMPARATOR

exploration in white light (WLI)

Intervention Type: PROCEDURE

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

Exploration in LCI

Intervention Type: PROCEDURE

Exploration of the right colon in linked color imaging (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)

Group Type: ACTIVE_COMPARATOR

exploration in white light (WLI)

Intervention Type: PROCEDURE

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

Exploration in LCI

Intervention Type: PROCEDURE

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

Interventions

exploration in white light (WLI)

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

Intervention Type: PROCEDURE

Exploration in LCI

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Société Française d'Endoscopie Digestive

OTHER

Sponsor Role: lead

Responsible Party

KARSENTI

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David KARSENTI, MD

Role: PRINCIPAL_INVESTIGATOR

Société Française d'Endoscopie Digestive

Locations

Clinique Paris-Bercy

Charenton-le-Pont, , France

Countries

France

Other Identifiers

ID-RCB 2019-A01287-50

Identifier Type: -

Identifier Source: org_study_id