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

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ClinicalTrials.gov Identifier: NCT02724397
Recruitment Status : Unknown
Verified January 2017 by Affiliated Hospital to Academy of Military Medical Sciences.
Recruitment status was:  Recruiting
First Posted : March 31, 2016
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colon Cancer Device: LCI/BLI then white endoscopy Device: White endoscopy and then LCI/BLI Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Linked Color Imaging (LCI) and Magnifying Blue Laser Imaging (BLI) Versus Standard White Light for the Detection of Adenomas and Serrated Lesions in the Proximal Colon
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : October 1, 2017
Estimated Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
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.
Other Name: Linked Color Imaging/Magnifying Blue Laser Imaging(LCI/BLI)

Active Comparator: 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.
Device: 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.
Other Name: Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI)




Primary Outcome Measures :
  1. Number of Proximal Serrated lesions and colorectal adenomas in proximal colon [ Time Frame: 6 months ]
    Quantity of serrated lesions and colorectal adenomas found in the proximal colon during colonoscopy was recorded and compared.


Secondary Outcome Measures :
  1. Improvement of histological diagnosis for serrated lesions and colorectal adenomas using LCI/BLI by comparing with that under white endoscopy [ Time Frame: 3 months ]
    It is anticipated that the use of Linked Color Imaging (LCI) and Magnifying Blue Laser Imaging (BLI) will significantly improve the histological detection of colonic adenomas and serrated lesions when detected as opposed to White Light Endoscopy.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02724397


Contacts
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Contact: Min Min, M.D., Ph.D. +86-010-66947473 minmin823@sina.com
Contact: Xiaotian Sun, M.D., Ph.D. +86-010-66947473 xiaotian-sun@hotmail.com

Locations
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China
Affiliated Hospital to Academy of Military Medical Sciences Recruiting
Beijing, China
Contact: Min Min         
Sponsors and Collaborators
Affiliated Hospital to Academy of Military Medical Sciences
Investigators
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Principal Investigator: Yan Liu, M.D., Ph.D. Affiliated Hospital to Academy of Military Medical Sciences

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Affiliated Hospital to Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT02724397     History of Changes
Other Study ID Numbers: 307-LCI/BLI-002
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Affiliated Hospital to Academy of Military Medical Sciences:
Colon cancer
Diagnosis
Adenoma
Serrated lesions
Additional relevant MeSH terms:
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Colonic Neoplasms
Adenoma
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type