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

Valduce Hospital

Status: Unknown

Conditions: Adenoma Colon Polyp

Treatments: Device: LCI (Linked color imaging)

Study type: Interventional

Funder types: Other

Identifiers

NCT03279783

341/2017

Details and patient eligibility

About

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).

Enrollment: 752 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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752 participants in 2 patient groups

WLI (White light Imaging)

No Intervention group

Description:

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

LCI (Linked Color Imaging)

Active Comparator group

Description:

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

Treatment:

Device: LCI (Linked color imaging)