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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03279783
Enrollment
752
Registered
2017-09-12
Start date
2017-07-01
Completion date
2017-12-30
Last updated
2017-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoma Colon Polyp

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).

Interventions

DEVICELCI (Linked color imaging)

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

Sponsors

Valduce Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Right colon adenoma miss rateOne yearNumber of adenomas identified during the second right coloninspection/ overall number of adenomas identified during the first and the second right colon inspection

Secondary

MeasureTime frameDescription
Right colon advanced adenomas (size>1 cm and/or high grade displasia and/or villous component) miss rateOne yearNumber of advanced adenomas identified during the second right coloninspection/ overall number of advanced adenomas identified during the first and the second right colon inspection
Right colon sessile serrated lesions miss rateOne yearNumber 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026