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

NCT ID: NCT02982447

Last Updated: 2016-12-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-05-31

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.

Conditions

Colorectal Adenoma

Keywords

blue laser imaging,detection,randomized trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

blue laser imaging colonoscopy

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

conventional white light colonoscopy

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yangzhou No.1 People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

zhi jie-hua

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

zhi jie hua, postgraduate

Role: PRINCIPAL_INVESTIGATOR

First People's Hospital of Yangzhou

Locations

First people's hospital of yangzhou

Yangzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

zhi jie hua, postgraduate

Role: CONTACT

Phone: 0086+87981199

Email: prettycloud2@sohu.com

Facility Contacts

zhi jiehua, postgraduate

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 23494646 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23731034 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26770267 (View on PubMed)

Other Identifiers

Yangzhou1PH

Identifier Type: -

Identifier Source: org_study_id