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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

Tracking Information
First Submitted Date  ICMJE March 18, 2016
First Posted Date  ICMJE March 31, 2016
Last Update Posted Date January 31, 2017
Actual Study Start Date  ICMJE May 1, 2016
Estimated Primary Completion Date October 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02724397 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2016)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Linked Color Imaging/Magnifying Blue Laser Imaging vs. White Light for Adenomas and Serrated Lesions in Proximal Colon
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Colon Cancer
Intervention  ICMJE
  • 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)
  • 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)
Study Arms  ICMJE
  • 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).
    Intervention: Device: White endoscopy and then 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.
    Intervention: Device: LCI/BLI then white endoscopy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 30, 2017)
350
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2016)
200
Estimated Study Completion Date  ICMJE October 1, 2017
Estimated Primary Completion Date October 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02724397
Other Study ID Numbers  ICMJE 307-LCI/BLI-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Affiliated Hospital to Academy of Military Medical Sciences
Study Sponsor  ICMJE Affiliated Hospital to Academy of Military Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yan Liu, M.D., Ph.D. Affiliated Hospital to Academy of Military Medical Sciences
PRS Account Affiliated Hospital to Academy of Military Medical Sciences
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP