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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Condition or disease	Intervention/treatment	Phase
Adenoma Colon Polyp	Device: LCI (Linked color imaging)	Not Applicable

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
No Intervention: WLI (White light Imaging); Colonoscope withdrawal was performed in the right colon evaluating the mucosa using standard white light.
Active Comparator: LCI (Linked Color Imaging); Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked Color Imaging).	Device: LCI (Linked color imaging); Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked color imaging)

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Italy
Gastroenterology Unit, Valduce Hospital	Recruiting
Como, Italy, 22100
Contact: Franco Radaelli, MD 0039031324145 francoradaelli01@gmail.com

Sponsors and Collaborators

Valduce Hospital

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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