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

NCT02982447 | Unknown DMC

• 1 other identifier: Yangzhou1PH
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Adenoma

Keywords

blue laser imaging,detection,randomized trial

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Blue Laser Imaging colonoscopy

ACTIVE COMPARATOR

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

conventional white light colonoscopy

EXPERIMENTAL

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

Interventions

blue laser imaging colonoscopy DEVICE

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

Blue Laser Imaging colonoscopy

conventional white light colonoscopy DEVICE

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

conventional white light colonoscopy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yangzhou No.1 People's Hospital: lead

Study Sites (1)

First people's hospital of yangzhou

Yangzhou, Jiangsu, 225001, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 23494646 BACKGROUND

• 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.

  PMID: 23731034 RESULT

• 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.

  PMID: 26770267 RESULT

Study Officials

• zhi jie hua, postgraduate

  First People's Hospital of Yangzhou

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhi jie hua, postgraduate

CONTACT

0086+87981199; prettycloud2@sohu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2016
• First Posted: December 5, 2016
• Study Start: December 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: December 5, 2016

Record last verified: 2016-12

Locations

CN (1)