Narrow Band Imaging Versus White Light for Colonoscopy Serrate Lesions Detection

Hospital Beatriz Ângelo

Status: Unknown

Conditions: Colon Cancer; Colon Sessile Serrated Adenoma/Polyp

Treatments: Device: white light withdrawal; Device: narrow band imaging withdrawal

Study type: Interventional

Funder types: Other

Identifiers

NCT02876133

176

Details and patient eligibility

About

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.

Enrollment: 987 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients scheduled for elective colonoscopies

Exclusion criteria

• known polyposis syndromes
• primary sclerosing cholangitis
• inflammatory bowel disease
• personal colorectal cancer history

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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987 participants in 2 patient groups, including a placebo group

Narrow band imaging withdrawal

Experimental group

Description:

colonoscope withdrawal and mucosal inspection performed under narrow band imaging

Treatment:

Device: narrow band imaging withdrawal

white light withdrawal

Placebo Comparator group

Description:

colonoscope withdrawal and mucosal inspection performed under white light imaging

Treatment:

Device: white light withdrawal