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NCT02876133 Clinical Trial

Narrow Band Imaging Versus White Light for Colonoscopy Serrate Lesions Detection

Colon Cancer Clinical Trial

Official title:
Improving Colorectal Cancer Screening: Using Narrow Band Imaging for Colonic Sessile Serrated Lesions

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02876133
Other study ID # 176
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date August 2019

Study information
Verified date September 2018
Source Hospital Beatriz Ângelo
Contact Alexandre O Ferreira, MD
Email alex.gastrohep@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Colorectal cancer (CRC) is a leading cause of cancer death and its' incidence is rising in most European countries. Colonoscopy has been shown to reduce CRC incidence, however its effectiveness depends on the sensitivity to detect pre-malignant lesions.

Our aim is to evaluate narrow band imaging (NBI) during colonoscopy and serum miRNAs as novel tools for the early detection of colonic sessile serrated lesions (SSL). The investigators will perform a multicenter-randomized-controlled-trial to study the role of NBI in SSL detection.

Recruitment information / eligibility
Status Recruiting
Enrollment 987
Est. completion date August 2019
Est. primary completion date August 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients scheduled for elective colonoscopies

Exclusion Criteria:

- known polyposis syndromes

- primary sclerosing cholangitis

- inflammatory bowel disease

- personal colorectal cancer history

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• narrow band imaging withdrawal
colonoscope withdrawal and mucosal inspection performed under narrow band imaging
• white light withdrawal
colonoscope withdrawal and mucosal inspection performed under white light imaging

Locations
Country Name City State
Portugal Hospital Beatriz Ângelo Loures
Portugal Centro Hospitalar do Porto Porto
Portugal Instituto Português de Oncologia do Porto Porto

Sponsors (1)
Lead Sponsor Collaborator
Hospital Beatriz Ângelo

Country where clinical trial is conducted

Portugal, 

References & Publications (1)

Rex DK, Ahnen DJ, Baron JA, Batts KP, Burke CA, Burt RW, Goldblum JR, Guillem JG, Kahi CJ, Kalady MF, O'Brien MJ, Odze RD, Ogino S, Parry S, Snover DC, Torlakovic EE, Wise PE, Young J, Church J. Serrated lesions of the colorectum: review and recommendations from an expert panel. Am J Gastroenterol. 2012 Sep;107(9):1315-29; quiz 1314, 1330. doi: 10.1038/ajg.2012.161. Epub 2012 Jun 19. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary average number of serrated lesions =10 mm detected per colonoscopy immediate
Secondary Serrated class lesions detection rate number of patients with at least 1 lesion/total number of participants immediate
Secondary Serrated lesions <10 mm detected per colonoscopy immediate
Secondary SSL detection rate histologically defined according to the WHO criteria immediate
Secondary Adenoma detection rate number of patients with at least 1 adenoma/total number of participants immediate
Secondary Adenomas detected per colonoscopy immediate
Secondary Advanced (malignant) adenocarcinoma detection rate immediate
Secondary Incidence of procedure related adverse events immediate
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