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

NCT04112563 | Completed

• 1 other identifier: ID-RCB 2019-A01287-50
• Study Type: interventional
• Target: 686
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenoma Colon; Colon Polyp; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The factors influencing these missed polyp rates

  1 day

• The factors influencing these missed polyp rates

  1 day

• The characteristics of the missed polyps

  1 day

• The characteristics of the missed polyps

  1 day

• Adenoma Detection Rate (ADR)

  1 day

Study Arms (2)

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

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)

Procedure: exploration in white light (WLI); Procedure: Exploration in LCI

Interventions

exploration in white light (WLI) PROCEDURE

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

LCI-WLI group; WLI-LCI group

Exploration in LCI PROCEDURE

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

LCI-WLI group; WLI-LCI group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient consecutively admitted for routine colonoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Société Française d'Endoscopie Digestive: lead

Study Sites (1)

Clinique Paris-Bercy

Charenton-le-Pont, 94220, France

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• David KARSENTI, MD

  Société Française d'Endoscopie Digestive

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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)

Study Record Dates

• First Submitted: September 29, 2019
• First Posted: October 2, 2019
• Study Start: January 1, 2020
• Primary Completion: December 22, 2022
• Study Completion: December 29, 2022
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)