Linked Color Imaging vs. White Light for Colorectal Dysplasia in Ulcerative Colitis

Not Applicable

• Conditions: Ulcerative Colitis
• Interventions: Device: white light imaging; Device: Linked Color Imaging

• Registration Number: NCT02772406
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary

The purpose of the study is to determine whether a new colonoscopic viewing technique called Linked color imaging(LCI) helps endoscopists detect more dysplasia lesions in ulcerative colitis patients than conventional colonoscopy using white light alone.

Detailed Description

Patients with longstanding IBD have increased risk of colorectal cancer (CRC) compared to the general population. The association between duration of the disease and development of CRC is the rationale for endoscopic surveillance. Colonoscopic surveillance of ulcerative colitis patients has been shown to reduce the risk of colorectal cancer and allow detection at an earlier stage, but even with meticulous examination, some precancerous lesions or cancers are missed. The newly developed LCI system (FUJIFILM Co.) creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of BLI technology. LCI makes red areas appear redder and white areas appear whiter. Thus, it is easier to recognize a slight difference in color of the mucosa. This is a study to determine if using Linked color imaging (LCI) of the colon, rather than the usual white light on the colon, will improve the detection of more dysplasia lesions in ulcerative colitis.

Study Timeline

• Study Start: 2016-04
• Status Verified: 2016-05
• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-05-12
• Last Update Submitted: 2016-05-12
• Study First Posted: 2016-05-13
• Last Update Posted: 2016-05-13
• Primary Completion: 2016-10
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

patients with ulcerative colitis who meet surveillance criteria

Exclusion Criteria

pregnant patients,unable or unwilling to give informed consent,patients with severe active colitis who would be unsafe to endoscope

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control group	white light imaging	(With white light endoscopy and 1 month later with LCI endoscopy) The patients will be evaluated by White Light endoscopy and 1 month later evaluated by Linked Color Imaging
Experimental group	Linked Color Imaging	(With LCI endoscopy and 1 month later with white light endoscopy) The patients will be evaluated by Linked Color Imaging and 1 month later evaluated by White Light endoscopy

Primary Outcome Measures

Name	Time	Method
The number of Colorectal Dysplasia detected by LCI	6 months

Secondary Outcome Measures

Name	Time	Method
The endoscopic scores with LCI	6 months

Trial Locations

Locations (1)

Affiliated Hospital to Academy of Military Medical Sciences; 🇨🇳 Beijing, Beijing, China