Narrow Band Imaging in Diagnosis of Colorectal Polyps

NCT ID: NCT04831814

Last Updated: 2021-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-04

Study Completion Date

2021-01-14

Brief Summary

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Optical diagnosis of colorectal polyps is a promising tool to avoid risks of unnecessary polypectomies and to save costs of tissue pathology. NICE (NBI International Colorectal Endoscopic) and WASP (Workgroup on Serrated Polyps and Polyposis) classification were developed for diagnosis of adenomatous and sessile serrated polyps, respectively.

Detailed Description

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Near-focus (NF) narrow-band imaging (NBI) is an image-magnifying technology which enables optical magnification of up to 65x in near focus (NF) compared with 52x in normal standard focus (SF) with the simple push of a button of the endoscope to be interchangeable between NF and SF. There were few studies comparing diagnostic accuracy between NF and SF in the diagnosis of colorectal polyps. So, our aim of the current study is to compare accuracy of NF NBI compared with SF NBI in the optical diagnosis of neoplastic and non-neoplastic polyp and the accuracy of NF NBI versus SF NBI in distinguishing serrated adenoma from hyperplastic polyp in sessile lesions using histologic evaluation as the gold standard.

Conditions

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Colorectal Polyp Colorectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Near Focus NBI

Use of the Near Focus NBI to make optical diagnosis

Group Type EXPERIMENTAL

Near Focus NBI

Intervention Type DIAGNOSTIC_TEST

Colonoscopy with near focus narrowing band imaging technology . Optical specifications include a 2 mm near field focal depth. Optical diagnosis of polyps were according to NICE and WASP, respectively.

Standard Focus NBI

Use of the Standard Focus NBI to make optical diagnosis

Group Type ACTIVE_COMPARATOR

Standard Focus NBI

Intervention Type DIAGNOSTIC_TEST

Colonoscopy with narrow band imaging technology.Optical diagnosis of polyps were according to NICE and WASP, respectively.

Interventions

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Near Focus NBI

Colonoscopy with near focus narrowing band imaging technology . Optical specifications include a 2 mm near field focal depth. Optical diagnosis of polyps were according to NICE and WASP, respectively.

Intervention Type DIAGNOSTIC_TEST

Standard Focus NBI

Colonoscopy with narrow band imaging technology.Optical diagnosis of polyps were according to NICE and WASP, respectively.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients who were scheduled for colonoscopy at NKC institute

Exclusion Criteria

* Inflammatory bowel disease
* Polyposis syndrome
* Colorectal cancer
* Active gastrointestinal bleeding
* Pregnant woman
* Inadequate bowel preparation
* Contraindication for polyps removal
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Nisa Netinatsunton

Principal Investigation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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NISA NETINATSUNTON, MD.

Role: PRINCIPAL_INVESTIGATOR

NKC Institute of Gastroenterology and Hepatology, Prince of Songkla University

Locations

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Prince Songkla University

Hat Yai, Changwat Songkhla, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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61355143

Identifier Type: -

Identifier Source: org_study_id

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