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Comparison of Detection and Miss Rates of Blue Laser Imaging Versus Conventional White Light Colonoscopy

Primary Purpose

Colorectal Adenoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
blue laser imaging colonoscopy
conventional white light colonoscopy
Sponsored by
Yangzhou No.1 People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Adenoma focused on measuring blue laser imaging,detection,randomized trial

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • consecutive patients who were underwent colonoscopy in our center for diagnostic work up of colonic symptoms,surveillance of colorectal polyps, and colorectal cancer screening.

Exclusion Criteria:

  • history of colon cancer, colectomy familial adenomatous polyposis, or inflammatory bowel diseases;
  • severe intestinal stenosis or obstruction;coagulation,disorders;
  • pregnancy;
  • and colonoscopy examinations with inadequate bowel cleanliness

Sites / Locations

  • First people's hospital of yangzhouRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Blue Laser Imaging colonoscopy

conventional white light colonoscopy

Arm Description

Insertion to cecum was performed under white light(WL) and once the cecum was reached, the Blue Laser Imaging mode was switched on during withdrawal of endoscope for complete colonic examination. Second colonoscopic examination was performed in a similar manner after the first complete withdrawal of the colonoscope. WL was used on insertion and WL was used on withdrawal

In this arm, WL was used for both insertion and withdrawal of the colonoscope during the first-pass and second-pass examinations.

Outcomes

Primary Outcome Measures

comparison of colorectal adenoma detection rates of blue laser imaging (BLI) Versus conventional White Light Colonoscopy
comparison of colorectal adenoma miss rates of blue laser imaging (BLI) Versus conventional White Light Colonoscopy

Secondary Outcome Measures

Full Information

First Posted
November 19, 2016
Last Updated
December 2, 2016
Sponsor
Yangzhou No.1 People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02982447
Brief Title
Comparison of Detection and Miss Rates of Blue Laser Imaging Versus Conventional White Light Colonoscopy
Official Title
Comparison of Detection and Miss Rates of Colorectal Adenoma by Blue Laser Imaging (BLI) Versus Conventional White Light Colonoscopy.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yangzhou No.1 People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
It is a randomized controlled trial with tandem colonoscopy.Participants were randomized for use of either blue laser imaging or conventional White Light Colonoscopy on withdrawal method.comparison of detection and miss rates of BLI group Versus conventional White Light Colonoscopy.
Detailed Description
blue laser imaging (BLI) are a new imaging systems used in endoscopy which are recently developed. According to three recently published reports, the diagnostic ability of adenoma characterization using blue laser imaging compares favorably with narrow band imaging. No published data are available to date regarding adenoma detection with blue laser imaging.BLI has the possibility to increase the detection of colorectal polyps by sufficient brightness and clearer endoscopic images.The investigators recruited participants who underwent colonoscopy for symptoms,screening,or surveillance.Participants were randomized for use of either blue laser imaging (BLI) or conventional white light colonoscopy on withdrawal method.Lesions detected on first-pass and second-pass examination were used for adenoma detection and miss rates,respectively.The primary outcomes is to compare the adenoma and poly detection rates of BLI with conventional white light Colonoscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Adenoma
Keywords
blue laser imaging,detection,randomized trial

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Blue Laser Imaging colonoscopy
Arm Type
Active Comparator
Arm Description
Insertion to cecum was performed under white light(WL) and once the cecum was reached, the Blue Laser Imaging mode was switched on during withdrawal of endoscope for complete colonic examination. Second colonoscopic examination was performed in a similar manner after the first complete withdrawal of the colonoscope. WL was used on insertion and WL was used on withdrawal
Arm Title
conventional white light colonoscopy
Arm Type
Experimental
Arm Description
In this arm, WL was used for both insertion and withdrawal of the colonoscope during the first-pass and second-pass examinations.
Intervention Type
Device
Intervention Name(s)
blue laser imaging colonoscopy
Intervention Description
Insertion to cecum was performed under white light(WL) and once the cecum was reached, the Blue Laser Imaging mode was switched on during withdrawal of endoscope for complete colonic examination. Second colonoscopic examination was performed in a similar manner after the first complete withdrawal of the colonoscope. WL was used on insertion and WL was used on withdrawal
Intervention Type
Device
Intervention Name(s)
conventional white light colonoscopy
Intervention Description
In this arm, WL was used for both insertion and withdrawal of the colonoscope during the first-pass and second-pass examinations.
Primary Outcome Measure Information:
Title
comparison of colorectal adenoma detection rates of blue laser imaging (BLI) Versus conventional White Light Colonoscopy
Time Frame
6 months
Title
comparison of colorectal adenoma miss rates of blue laser imaging (BLI) Versus conventional White Light Colonoscopy
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: consecutive patients who were underwent colonoscopy in our center for diagnostic work up of colonic symptoms,surveillance of colorectal polyps, and colorectal cancer screening. Exclusion Criteria: history of colon cancer, colectomy familial adenomatous polyposis, or inflammatory bowel diseases; severe intestinal stenosis or obstruction;coagulation,disorders; pregnancy; and colonoscopy examinations with inadequate bowel cleanliness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhi jie hua, postgraduate
Phone
0086+87981199
Email
prettycloud2@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhi jie hua, postgraduate
Organizational Affiliation
First People's Hospital of Yangzhou
Official's Role
Principal Investigator
Facility Information:
Facility Name
First people's hospital of yangzhou
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhi jiehua, postgraduate
Phone
13921907913
Email
prettycloud2@tom.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23494646
Citation
Yoshida N, Hisabe T, Inada Y, Kugai M, Yagi N, Hirai F, Yao K, Matsui T, Iwashita A, Kato M, Yanagisawa A, Naito Y. The ability of a novel blue laser imaging system for the diagnosis of invasion depth of colorectal neoplasms. J Gastroenterol. 2014 Jan;49(1):73-80. doi: 10.1007/s00535-013-0772-7. Epub 2013 Mar 15.
Results Reference
background
PubMed Identifier
23731034
Citation
Yoshida N, Yagi N, Inada Y, Kugai M, Okayama T, Kamada K, Katada K, Uchiyama K, Ishikawa T, Handa O, Takagi T, Konishi H, Kokura S, Yanagisawa A, Naito Y. Ability of a novel blue laser imaging system for the diagnosis of colorectal polyps. Dig Endosc. 2014 Mar;26(2):250-8. doi: 10.1111/den.12127. Epub 2013 Jun 3.
Results Reference
result
PubMed Identifier
26770267
Citation
Togashi K, Nemoto D, Utano K, Isohata N, Kumamoto K, Endo S, Lefor AK. Blue laser imaging endoscopy system for the early detection and characterization of colorectal lesions: a guide for the endoscopist. Therap Adv Gastroenterol. 2016 Jan;9(1):50-6. doi: 10.1177/1756283X15603614.
Results Reference
result

Learn more about this trial

Comparison of Detection and Miss Rates of Blue Laser Imaging Versus Conventional White Light Colonoscopy

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