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

Adenoma Colon Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03279783
• Other study ID #: 341/2017
• Status: Recruiting
• Phase: N/A
• First received: August 24, 2017
• Last updated: September 10, 2017
• Start date: July 1, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: September 2017
• Source: Valduce Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 752
• Est. completion date: December 30, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon Polyp

Intervention

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

Locations

Country	Name	City	State
Italy	Gastroenterology Unit, Valduce Hospital	Como

Sponsors (1)

Lead Sponsor	Collaborator
Valduce Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Right colon advanced adenomas (size>1 cm and/or high grade displasia and/or villous component) miss rate	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	One year
Secondary	Right colon sessile serrated lesions miss rate	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	One year