Narrow Band Imaging in Diagnosis of Colorectal Polyps

Not Applicable

Completed

• Conditions: Colorectal Neoplasms; Colorectal Polyp
• Interventions: Diagnostic Test: Near Focus NBI; Diagnostic Test: Standard Focus NBI

• Registration Number: NCT04831814
• Lead Sponsor: Prince of Songkla University

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-04-04
• Primary Completion: 2020-07-02
• Study Completion: 2021-01-14
• Status Verified: 2021-03
• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-04-02
• Study First Posted: 2021-04-05
• Last Update Submitted: 2021-05-11
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Near Focus NBI	Near Focus NBI	Use of the Near Focus NBI to make optical diagnosis
Standard Focus NBI	Standard Focus NBI	Use of the Standard Focus NBI to make optical diagnosis

Primary Outcome Measures

Name	Time	Method
Rate of accurate diagnosis of sessile serrated polyps/adenoma by the Endoscopists in the two groups.	At the time of procedure	Measure of the percentage od accurate predictions by the endoscopists in the differentiation of sessile serrated polyps/adenoma from hyperplastic polyps, using the high definition NBI colonoscopy with and without near focus features.
Rate of accurate polyp histology predictions by the Endoscopists in the two groups.	At the time of procedure	Measure of the percentage of accurate predictions by the endoscopists in the differentiation of neoplastic from non neoplastic colorectal lesions, using the high definition NBI colonoscopy with and without near focus features

Secondary Outcome Measures

Name	Time	Method
The adenoma detection rate	At the time of procedure	The prevalence of patients with at least one adenoma was detected
The polyp detection rate	At the time of procedure	The prevalence of patients with at least one polyp was detected
Diagnostic Characteristics	At the time of procedure	Compare the diagnostic characteristic (sensitivity, specificity, positive predictive value and negative predictive value) using the high definition narrow band imaging colonoscopy with and without near focus features.

Trial Locations

Locations (1)

Prince Songkla University; 🇹🇭 Hat Yai, Songkhla, Thailand