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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

752 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2017-12-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Adenoma Colon Polyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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 (Linked Color Imaging). Patients are randomly assigned (1:1), via computer-generated randomisation with block size of 20, to which procedure is done first.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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WLI (White light Imaging)

Colonoscope withdrawal was performed in the right colon evaluating the mucosa using standard white light.

Group Type NO_INTERVENTION

No interventions assigned to this group

LCI (Linked Color Imaging)

Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked Color Imaging).

Group Type ACTIVE_COMPARATOR

LCI (Linked color imaging)

Intervention Type DEVICE

Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked color imaging)

Interventions

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LCI (Linked color imaging)

Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked color imaging)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No