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

Colorectal Adenoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02982447
• Other study ID #: Yangzhou1PH
• Status: Recruiting
• Phase: N/A
• First received: November 19, 2016
• Last updated: December 2, 2016
• Start date: December 2016
• Est. completion date: May 2017

Study information

• Verified date: December 2016
• Source: Yangzhou No.1 People's Hospital
• Contact: zhi jie hua, postgraduate
• Phone: 0086+87981199
• Email: prettycloud2[@]sohu.com
• Is FDA regulated: No
• Health authority: China: Jiangsu Province Health Department
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma

Intervention

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
• 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.

Locations

Country	Name	City	State
China	First people's hospital of yangzhou	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou No.1 People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (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: — View 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. — View 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. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of colorectal adenoma detection rates of blue laser imaging (BLI) Versus conventional White Light Colonoscopy		6 months	No
Primary	comparison of colorectal adenoma miss rates of blue laser imaging (BLI) Versus conventional White Light Colonoscopy		6 months	No