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

Primary Purpose

Colon Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
LCI/BLI then white endoscopy
White endoscopy and then LCI/BLI
Sponsored by
Affiliated Hospital to Academy of Military Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colon Cancer focused on measuring Colon cancer, Diagnosis, Adenoma, Serrated lesions

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Affiliated Hospital to Academy of Military Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

(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).

(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.

Outcomes

Primary Outcome Measures

Number of Proximal Serrated lesions and colorectal adenomas in proximal colon
Quantity of serrated lesions and colorectal adenomas found in the proximal colon during colonoscopy was recorded and compared.

Secondary Outcome Measures

Improvement of histological diagnosis for serrated lesions and colorectal adenomas using LCI/BLI by comparing with that under white endoscopy
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.

Full Information

First Posted
March 18, 2016
Last Updated
January 30, 2017
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02724397
Brief Title
Linked Color Imaging/Magnifying Blue Laser Imaging vs. White Light for Adenomas and Serrated Lesions in Proximal Colon
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
October 1, 2017 (Anticipated)
Study Completion Date
October 1, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Colon cancer, Diagnosis, Adenoma, Serrated lesions

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
(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).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
(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 Type
Device
Intervention Name(s)
LCI/BLI then white endoscopy
Other Intervention Name(s)
Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI)
Intervention Description
First use of Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI) and then White Light Endoscopy to detect colonic adenomas.
Intervention Type
Device
Intervention Name(s)
White endoscopy and then LCI/BLI
Other Intervention Name(s)
Linked Color Imaging/Magnifying Blue Laser Imaging(LCI/BLI)
Intervention Description
First use of White Light Endoscopy and then Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI) to detect colonic adenomas.
Primary Outcome Measure Information:
Title
Number of Proximal Serrated lesions and colorectal adenomas in proximal colon
Description
Quantity of serrated lesions and colorectal adenomas found in the proximal colon during colonoscopy was recorded and compared.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Improvement of histological diagnosis for serrated lesions and colorectal adenomas using LCI/BLI by comparing with that under white endoscopy
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Min, M.D., Ph.D.
Phone
+86-010-66947473
Email
minmin823@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaotian Sun, M.D., Ph.D.
Phone
+86-010-66947473
Email
xiaotian-sun@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Liu, M.D., Ph.D.
Organizational Affiliation
Affiliated Hospital to Academy of Military Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital to Academy of Military Medical Sciences
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Min

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21732270
Citation
Sato R, Fujiya M, Watari J, Ueno N, Moriichi K, Kashima S, Maeda S, Ando K, Kawabata H, Sugiyama R, Nomura Y, Nata T, Itabashi K, Inaba Y, Okamoto K, Mizukami Y, Saitoh Y, Kohgo Y. The diagnostic accuracy of high-resolution endoscopy, autofluorescence imaging and narrow-band imaging for differentially diagnosing colon adenoma. Endoscopy. 2011 Oct;43(10):862-8. doi: 10.1055/s-0030-1256510. Epub 2011 Jul 5.
Results Reference
background
PubMed Identifier
25952085
Citation
Rex DK, Clodfelter R, Rahmani F, Fatima H, James-Stevenson TN, Tang JC, Kim HN, McHenry L, Kahi CJ, Rogers NA, Helper DJ, Sagi SV, Kessler WR, Wo JM, Fischer M, Kwo PY. Narrow-band imaging versus white light for the detection of proximal colon serrated lesions: a randomized, controlled trial. Gastrointest Endosc. 2016 Jan;83(1):166-71. doi: 10.1016/j.gie.2015.03.1915. Epub 2015 May 5.
Results Reference
result
PubMed Identifier
28286095
Citation
Min M, Deng P, Zhang W, Sun X, Liu Y, Nong B. Comparison of linked color imaging and white-light colonoscopy for detection of colorectal polyps: a multicenter, randomized, crossover trial. Gastrointest Endosc. 2017 Oct;86(4):724-730. doi: 10.1016/j.gie.2017.02.035. Epub 2017 Mar 9.
Results Reference
derived

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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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