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

NCT03279783 | Unknown

• 1 other identifier: 341/2017
• Study Type: interventional
• Target: 752
• Locations: 1 country
• Sites: 1

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).

Conditions

Adenoma Colon Polyp

Outcome Measures

Primary Outcomes (1)

• Right colon adenoma miss rate

  Number of adenomas identified during the second right coloninspection/ overall number of adenomas identified during the first and the second right colon inspection

  One year

Secondary Outcomes (2)

• Right colon advanced adenomas (size>1 cm and/or high grade displasia and/or villous component) miss rate

  One year

• Right colon sessile serrated lesions miss rate

  One year

Study Arms (2)

WLI (White light Imaging)

NO INTERVENTION

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

LCI (Linked Color Imaging)

ACTIVE COMPARATOR

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

Device: LCI (Linked color imaging)

Interventions

LCI (Linked color imaging) DEVICE

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

LCI (Linked Color Imaging)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all outpatients referred for colonoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Valduce Hospital: lead

Study Sites (1)

Gastroenterology Unit, Valduce Hospital

Como, 22100, Italy

RECRUITING

Related Publications (1)

• Paggi S, Mogavero G, Amato A, Rondonotti E, Andrealli A, Imperiali G, Lenoci N, Mandelli G, Terreni N, Conforti FS, Conte D, Spinzi G, Radaelli F. Linked color imaging reduces the miss rate of neoplastic lesions in the right colon: a randomized tandem colonoscopy study. Endoscopy. 2018 Apr;50(4):396-402. doi: 10.1055/a-0580-7405. Epub 2018 Mar 14.

  PMID: 29539651 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Endoscopy Unit

Model Details: 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.

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: September 12, 2017
• Study Start: July 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 30, 2017
• Last Updated: September 12, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)