Linked-color Imaging for the Detection of Colorectal Flat Lesions

Colonic Polyp Clinical Trial

Official title:

Linked-color Imaging Versus White Light for the Detection of Colorectal Flat Lesions: a Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272945
• Other study ID #: LCI
• Status: Completed
• Phase: N/A
• Start date: September 6, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: Showa Inan General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Linked color imaging (LCI) was recently developed and uses a laser endoscopic system (Fujifilm Co, Tokyo, Japan) that acquires images by simultaneously using narrow-band short-wavelength light and white-light (WL) in an appropriate balance. LCI is a new image-enhancing technology that is intended to enhance slight color differences in the red region of the mucosa. The acquired color information is reallocated to differentiate colors that are similar to the mucosal color, resulting in improved performance in depicting blood vessels, and additional image processing that enhances color separation for red color permits clear visualization of red blood vessels and white pits. This modality may increase the detection rate of colorectal polyps by enhancing the visibility of colonic mucosal vessels. In addition, it has been reported that LCI increases the visibility of colorectal flat lesions and contributes to improvement of the detection rate for these lesions. The primary aim of the current study was to compare the detection rate of colorectal flat lesions of LCI cap-assisted colonoscopy with WL cap-assisted colonoscopy in prospective randomized trial. In addition, we prospectively compared LCI and WL with regard to the visibility of colorectal flat lesions found in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• We enrolled consecutive patients who were referred for colonoscopy to our hospital for diagnostic work up of colonic symptoms, surveillance of colorectal polyps, and colorectal cancer screening.

Exclusion Criteria:

• familial colorectal cancer syndrome including familial adenomatous polyposis and hereditary non-polyposis colorectal cancer syndrome, personal history of colorectal cancer or inflammatory bowel disease and those who had previous colonic resection.

Patients who were considered to be unsafe for polypectomy, including patients with bleeding tendency and those with severe comorbid illnesses, were excluded. Those in whom <90% of mucosa was seen due to mixture of semisolid and solid colonic contents were also excluded because of poor bowel preparation.

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps

Intervention

Procedure:
• Linked-color imaging
Linked-color imaging colonoscopy

Locations

Country	Name	City	State
Japan	Showa Inan General hospital	Komagane	Nagano

Sponsors (1)

Lead Sponsor	Collaborator
Showa Inan General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The visibility of colorectal flat lesions	Six endoscopists interpreted the images of CLI and WL. By using a previously reported visibility scale, we scored the visibility level on a scale of 1 to 4 and compared the two groups.	1 day
Primary	Average prevalence of flat lesion /patient detected	The total number of flat colorectal lesion/patient was defined. The average prevalence of flat lesion /patient detected was calculated.	procedure
Secondary	Adenoma detection rate	Adenoma detection rate was defined as the proportion of patients with at least one adenoma found on colonoscopy.	procedure
Secondary	Polyp detection rate	Polyp detection rate was defined as the proportion of patients with at least one polyp found on colonoscopy.	procedure