Narrow Band Imaging Versus White Light for Colonoscopy Serrate Lesions Detection

Study Overview
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Brief Summary
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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.

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

Conditions
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Colon Cancer, Colon Sessile Serrated Adenoma/Polyp

Intervention / Treatment
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* Device: narrow band imaging withdrawal
* Device: white light withdrawal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for elective colonoscopies Exclusion Criteria: known polyposis syndromes primary sclerosing cholangitis inflammatory bowel disease personal colorectal cancer history

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Narrow band imaging withdrawal<br>colonoscope withdrawal and mucosal inspection performed under narrow band imaging | Device: narrow band imaging withdrawal<br>* colonoscope withdrawal and mucosal inspection performed under narrow band imaging<br>|
| Placebo Comparator: white light withdrawal<br>colonoscope withdrawal and mucosal inspection performed under white light imaging | Device: white light withdrawal<br>* colonoscope withdrawal and mucosal inspection performed under white light imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average number of serrated lesions ≥10 mm detected per colonoscopy |  | immediate | 

Secondary Outcome Measures

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