Narrow Band Imaging Versus White Light for Colonoscopy Serrate Lesions Detection

Not Applicable

• Conditions: Colon Cancer; Colon Sessile Serrated Adenoma/Polyp
• Interventions: Device: narrow band imaging withdrawal; Device: white light withdrawal

• Registration Number: NCT02876133
• Lead Sponsor: Hospital Beatriz Ângelo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-18
• Study First Submitted QC: 2016-08-18
• Study First Posted: 2016-08-23
• Study Start: 2016-11
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-25
• Last Update Posted: 2018-09-26
• Primary Completion: 2019-08
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 987

Inclusion Criteria

• Patients scheduled for elective colonoscopies

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Narrow band imaging withdrawal	narrow band imaging withdrawal	colonoscope withdrawal and mucosal inspection performed under narrow band imaging
white light withdrawal	white light withdrawal	colonoscope withdrawal and mucosal inspection performed under white light imaging

Primary Outcome Measures

Name	Time	Method
average number of serrated lesions ≥10 mm detected per colonoscopy	immediate

Secondary Outcome Measures

Name	Time	Method
Serrated lesions <10 mm detected per colonoscopy	immediate
Serrated class lesions detection rate	immediate	number of patients with at least 1 lesion/total number of participants
Adenomas detected per colonoscopy	immediate
SSL detection rate	immediate	histologically defined according to the WHO criteria
Adenoma detection rate	immediate	number of patients with at least 1 adenoma/total number of participants
Advanced (malignant) adenocarcinoma detection rate	immediate
Incidence of procedure related adverse events	immediate

Trial Locations

Locations (3)

Instituto Português de Oncologia do Porto; 🇵🇹 Porto, Portugal

Centro Hospitalar do Porto; 🇵🇹 Porto, Portugal

Hospital Beatriz Ângelo; 🇵🇹 Loures, Portugal