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

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ClinicalTrials.gov Identifier: NCT02982447
Recruitment Status : Recruiting
First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
zhi jie-hua, Yangzhou No.1 People's Hospital

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.

Condition or disease Intervention/treatment Phase
Colorectal Adenoma Device: blue laser imaging colonoscopy Device: conventional white light colonoscopy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Detection and Miss Rates of Colorectal Adenoma by Blue Laser Imaging (BLI) Versus Conventional White Light Colonoscopy.
Study Start Date : December 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Blue Laser Imaging colonoscopy
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
Device: blue laser imaging colonoscopy
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
Experimental: conventional white light colonoscopy
In this arm, WL was used for both insertion and withdrawal of the colonoscope during the first-pass and second-pass examinations.
Device: conventional white light colonoscopy
In this arm, WL was used for both insertion and withdrawal of the colonoscope during the first-pass and second-pass examinations.



Primary Outcome Measures :
  1. comparison of colorectal adenoma detection rates of blue laser imaging (BLI) Versus conventional White Light Colonoscopy [ Time Frame: 6 months ]
  2. comparison of colorectal adenoma miss rates of blue laser imaging (BLI) Versus conventional White Light Colonoscopy [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT02982447


Contacts
Contact: zhi jie hua, postgraduate 0086+87981199 prettycloud2@sohu.com

Locations
China, Jiangsu
First people's hospital of yangzhou Recruiting
Yangzhou, Jiangsu, China, 225001
Contact: zhi jiehua, postgraduate    13921907913    prettycloud2@tom.com   
Sponsors and Collaborators
Yangzhou No.1 People's Hospital
Investigators
Principal Investigator: zhi jie hua, postgraduate First people's hospital of yangzhou

Publications of Results:
Other Publications:
Responsible Party: zhi jie-hua, Principal Investigator, Yangzhou No.1 People's Hospital
ClinicalTrials.gov Identifier: NCT02982447     History of Changes
Other Study ID Numbers: Yangzhou1PH
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by zhi jie-hua, Yangzhou No.1 People's Hospital:
blue laser imaging,detection,randomized trial

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms