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

Comparison of Detection and Miss Rates of Colorectal Adenoma by Blue Laser Imaging (BLI) Versus Conventional White Light Colonoscopy.

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Adenoma
• Intervention / Treatment: Device: blue laser imaging colonoscopy; Device: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 420
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225001
      • Recruiting
      • First People's Hospital of Yangzhou
      • Contact: zhi jiehua, postgraduate; Phone Number: 13921907913; Email: prettycloud2@tom.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
comparison of colorectal adenoma detection rates of blue laser imaging (BLI) Versus conventional White Light Colonoscopy	6 months
comparison of colorectal adenoma miss rates of blue laser imaging (BLI) Versus conventional White Light Colonoscopy	6 months

Collaborators and Investigators

• Sponsor: Yangzhou No.1 People's Hospital
• Investigators: Principal Investigator: zhi jie hua, postgraduate, First People's Hospital of Yangzhou

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: November 19, 2016
• First Submitted That Met QC Criteria: December 2, 2016
• First Posted (Estimate): December 5, 2016

Study Record Updates

• Last Update Posted (Estimate): December 5, 2016
• Last Update Submitted That Met QC Criteria: December 2, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: blue laser imaging,detection,randomized trial
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: Yangzhou1PH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided