LCI (Linked Color Imaging) for Adenoma Detection in the Right Colon
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ClinicalTrials.gov Identifier: NCT03279783 |
Recruitment Status
:
Recruiting
First Posted
: September 12, 2017
Last Update Posted
: September 12, 2017
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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).
Condition or disease | Intervention/treatment | Phase |
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Adenoma Colon Polyp | Device: LCI (Linked color imaging) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 752 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
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. |
Masking: | Single (Participant) |
Primary Purpose: | Diagnostic |
Official Title: | LCI (Linked Color Imaging) for Adenoma Detection in the Right Colon |
Actual Study Start Date : | July 1, 2017 |
Estimated Primary Completion Date : | December 1, 2017 |
Estimated Study Completion Date : | December 30, 2017 |

Arm | Intervention/treatment |
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No Intervention: WLI (White light Imaging)
Colonoscope withdrawal was performed in the right colon evaluating the mucosa using standard white light.
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Active Comparator: LCI (Linked Color Imaging)
Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked Color Imaging).
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Device: LCI (Linked color imaging)
Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked color imaging)
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- Right colon adenoma miss rate [ Time Frame: 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
- Right colon advanced adenomas (size>1 cm and/or high grade displasia and/or villous component) miss rate [ Time Frame: 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
- Right colon sessile serrated lesions miss rate [ Time Frame: 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

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279783
Italy | |
Gastroenterology Unit, Valduce Hospital | Recruiting |
Como, Italy, 22100 | |
Contact: Franco Radaelli, MD 0039031324145 francoradaelli01@gmail.com |
Responsible Party: | Franco Radaelli, Head of Endoscopy Unit, Valduce Hospital |
ClinicalTrials.gov Identifier: | NCT03279783 History of Changes |
Other Study ID Numbers: |
341/2017 |
First Posted: | September 12, 2017 Key Record Dates |
Last Update Posted: | September 12, 2017 |
Last Verified: | September 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |