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

Not Applicable

• Conditions: Adenoma Colon Polyp
• Interventions: Device: LCI (Linked color imaging)

• Registration Number: NCT03279783
• Lead Sponsor: Valduce Hospital

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-08-24
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-10
• Last Update Submitted: 2017-09-10
• Study First Posted: 2017-09-12
• Last Update Posted: 2017-09-12
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 752

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LCI (Linked Color Imaging)	LCI (Linked color imaging)	Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked Color Imaging).

Primary Outcome Measures

Name	Time	Method
Right colon adenoma miss rate	One year	Number of adenomas identified during the second right coloninspection/ overall number of adenomas identified during the first and the second right colon inspection

Secondary Outcome Measures

Name	Time	Method
Right colon sessile serrated lesions miss rate	One year	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
Right colon advanced adenomas (size>1 cm and/or high grade displasia and/or villous component) miss rate	One year	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

Trial Locations

Locations (1)

Gastroenterology Unit, Valduce Hospital; 🇮🇹 Como, Italy