LCI (Linked Color Imaging) for Adenoma Detection in the Right Colon

Although colonoscopy with polypectomy can prevent up to 80% of colorectal cancers, a significant adenoma miss rate still exists, particularly in the right colon. Optimizing the detection of adenomas and sessile serrated lesions in the right colon is crucial to increase the effectiveness of colonoscopy in colorectal cancer prevention.

Last generation Fuji videocolonscopes incorporates the Linked Color Imaging (LCI), a recently developed technology that differentiates the red colour spectrum more effectively than White Light imaging thanks to its optimal pre-process composition of light spectrum and advanced signal processing. The increased colour contrast results in more accurate delineation of abnormal inflammatory or neoplastic findings of colonic mucosa. Preliminary data suggest that LCI may be improve the detection of neoplastic lesion of colon.

The investigators performe a tandem prospective study to compare the right colon adenoma miss rates of LCI colonoscopy with those of conventional white light colonoscopy.

Therefore participants scheduled for colonoscopy for the assessment of symptoms or for colorectal cancer screening/surveillance receive the examination of the right colon twice, in a back to back fashion, with standard white light (WL) and with LCI. Patients are randomly assigned (1:1), via computer-generated randomisation with block size of 20, to which procedure is done first. The endoscopist are masked to group allocation until immediately before the cecum is reached. Examinations are performed with Fuji videocolonscopes series 700 (EC-760R, EC-760ZP).

Study Overview

• Status: Unknown
• Conditions: Adenoma Colon Polyp
• Intervention / Treatment: Device: LCI (Linked color imaging)

• Study Type: Interventional
• Enrollment (Anticipated): 752
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Como, Italy, 22100
    • Recruiting
    • Gastroenterology Unit, Valduce Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all outpatients referred for colonoscopy

Exclusion Criteria:

• inadequatete bowel preparation (Boston Bowel Preparation Scale (BBPS) < 2 in one colonic segment)
• previous colonic resection
• inflammatory bowel disease
• ereditary polyposic syndromes
• patients on antithrombotics precluding polyp recetion
• absence of informed consent
• inpatients or patients undergoing urgent colonscopy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: WLI (White light Imaging); Colonoscope withdrawal was performed in the right colon evaluating the mucosa using standard white light.
ACTIVE_COMPARATOR: LCI (Linked Color Imaging); Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked Color Imaging).	Device: LCI (Linked color imaging); Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked color imaging)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right colon adenoma miss rate	Number of adenomas identified during the second right coloninspection/ overall number of adenomas identified during the first and the second right colon inspection	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right colon advanced adenomas (size>1 cm and/or high grade displasia and/or villous component) miss rate	Number of advanced adenomas identified during the second right coloninspection/ overall number of advanced adenomas identified during the first and the second right colon inspection	One year
Right colon sessile serrated lesions miss rate	Number of sessile serrated lesions identified during the second right coloninspection/ overall number of sessile serrated lesions identified during the first and the second right colon inspection	One year

Collaborators and Investigators

• Sponsor: Valduce Hospital

Publications and helpful links

General Publications

• Paggi S, Mogavero G, Amato A, Rondonotti E, Andrealli A, Imperiali G, Lenoci N, Mandelli G, Terreni N, Conforti FS, Conte D, Spinzi G, Radaelli F. Linked color imaging reduces the miss rate of neoplastic lesions in the right colon: a randomized tandem colonoscopy study. Endoscopy. 2018 Apr;50(4):396-402. doi: 10.1055/a-0580-7405. Epub 2018 Mar 14.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2017
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): December 30, 2017

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: September 10, 2017
• First Posted (ACTUAL): September 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 12, 2017
• Last Update Submitted That Met QC Criteria: September 10, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: 341/2017

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