NCT02724397

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

March 18, 2016

Last Update Submit

January 30, 2017

Conditions

Colon Cancer

Keywords

Colon cancerDiagnosisAdenomaSerrated lesions

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (1)

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

    3 months

Study Arms (2)

Experimental group

EXPERIMENTAL

(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

Control group

ACTIVE COMPARATOR

(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

Interventions

LCI/BLI then white endoscopyDEVICE

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

Also known as: Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI)
Control group
White endoscopy and then LCI/BLIDEVICE

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

Also known as: Linked Color Imaging/Magnifying Blue Laser Imaging（LCI/BLI)
Experimental group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive adult patients undergoing an outpatient colonoscopy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital to Academy of Military Medical Sciences

Beijing, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 21732270BACKGROUND

  • 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.

    PMID: 25952085RESULT

  • 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.

    PMID: 28286095DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsDiseaseAdenoma

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Yan Liu, M.D., Ph.D.

    Affiliated Hospital to Academy of Military Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Min, M.D., Ph.D.

CONTACT

+86-010-66947473minmin823@sina.com

Xiaotian Sun, M.D., Ph.D.

CONTACT

+86-010-66947473xiaotian-sun@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2016

First Posted

March 31, 2016

Study Start

May 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations

CN(1)