Linked Color Imaging/Magnifying Blue Laser Imaging vs. White Light for Adenomas and Serrated Lesions in Proximal Colon

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2017-10-01

Brief Summary

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Linked color imaging (LCI) and magnifying blue laser imaging (BLI) are two new imaging systems used in endoscopy which are recently developed. BLI was developed to compensate for the limitations of NBI. BLI shows a bright image of the digestive mucosa, enabling the detailed visualization of both the microstructure and microvasculature. However, BLI still is not able to obtain sufficient brightness for distant lesions. 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 LCI of the colon, rather than the usual white light on the colon, will improve the detection of flat adenomas and serrated polyps. The polyps are called serrated because of their appearance under the microscope after they have been removed. They tend to be located up high in the colon, far away from the rectum. They have been definitely shown to be a type of precancerous polyp and it is possible that using LCI will make it easier to see them, as they can be quite difficult to see with standard white light. LCI/BLI enables endoscopists to accurately describe the pit pattern of adenomas. By comparing White Light Endoscopy and LCI/BLI, it will show if there is any comparable advantage to using one or the other for lesion detection and assessment.

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Detailed Description

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This is a randomized controlled trial comparing the use of linked color imaging (LCI) and magnifying blue laser imaging (BLI) versus standard white light for the detection of serrated lesions in the proximal colon (the colon proximal to the splenic flexure). The proximal colon has large intestine and many folds which will lead missing flat lesions. Recent studies have indicated that colonoscopy is more effective in preventing cancer in the left side of the colon than the right side of the colon. The reasons for this difference may be partly biologic, in that a special group of polyps known as serrated polyps, particularly sessile serrated adenomas, are located primarily proximal to the splenic flexure. These lesions are endoscopically subtle in that they are often flat, have the same color as the surrounding mucosa, and are hard to differentiate from normal mucosa. 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 study will test whether LCI will increase the detection of serrated lesions in a randomized controlled trial.

Conditions

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Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental group

(White endoscopy and then LCI/BLI) The patients will be evaluated by Standard White Light and then Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI).

Group Type EXPERIMENTAL

White endoscopy and then LCI/BLI

Intervention Type DEVICE

First use of White Light Endoscopy and then Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI) to detect colonic adenomas.

Control group

(LCI/BLI then white endoscopy) The patients will be evaluated by Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI) and then White Light Endoscopy.

Group Type ACTIVE_COMPARATOR

LCI/BLI then white endoscopy

Intervention Type DEVICE

First use of Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI) and then White Light Endoscopy to detect colonic adenomas.

Interventions

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LCI/BLI then white endoscopy

First use of Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI) and then White Light Endoscopy to detect colonic adenomas.

Intervention Type DEVICE

White endoscopy and then LCI/BLI

First use of White Light Endoscopy and then Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI) to detect colonic adenomas.

Intervention Type DEVICE

Other Intervention Names

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Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI) Linked Color Imaging/Magnifying Blue Laser Imaging（LCI/BLI)

Eligibility Criteria

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Inclusion Criteria

--Consecutive adult patients undergoing an outpatient colonoscopy

Exclusion Criteria

* unable to provide informed consent
* had undergone prior resection of the colon
* inflammatory bowel disease
* familial adenomatous polyposis, Peutz-Jeghers syndrome or other polyposis syndromes.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes