Narrow Band Imaging Versus White Light for Colonoscopy Serrate Lesions Detection

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02876133

Enrollment

987

Registered

2016-08-23

Start date

2016-11-30

Completion date

2019-08-31

Last updated

2018-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer, Colon Sessile Serrated Adenoma/Polyp

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.

Interventions

DEVICEwhite light withdrawal

colonoscope withdrawal and mucosal inspection performed under white light imaging

DEVICEnarrow band imaging withdrawal

colonoscope withdrawal and mucosal inspection performed under narrow band imaging

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* Patients scheduled for elective colonoscopies

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
average number of serrated lesions ≥10 mm detected per colonoscopy	immediate

Secondary

Measure	Time frame	Description
Serrated lesions <10 mm 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
Serrated class lesions detection rate	immediate	number of patients with at least 1 lesion/total number of participants
Advanced (malignant) adenocarcinoma detection rate	immediate	—
Incidence of procedure related adverse events	immediate	—
Adenomas detected per colonoscopy	immediate	—

Countries

Portugal

Contacts

Primary ContactAlexandre O Ferreira, MD

alex.gastrohep@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026