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Clinical Trials/NCT04831814
NCT04831814
Completed
Not Applicable

Near-focus Versus Normal-focus Narrow Band Imaging Colonoscopy in Diagnosis of Colorectal Polyps Based on Combined NICE and WASP Classification: a Randomized Controlled Trial

Prince of Songkla University1 site in 1 country118 target enrollmentApril 4, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Polyp
Sponsor
Prince of Songkla University
Enrollment
118
Locations
1
Primary Endpoint
Rate of accurate diagnosis of sessile serrated polyps/adenoma by the Endoscopists in the two groups.
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 4, 2019
End Date
January 14, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nisa Netinatsunton

Principal Investigation

Prince of Songkla University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Rate of accurate diagnosis of sessile serrated polyps/adenoma by the Endoscopists in the two groups.

Time Frame: 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.

Time Frame: 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 Outcomes

  • The adenoma detection rate(At the time of procedure)
  • The polyp detection rate(At the time of procedure)
  • Diagnostic Characteristics(At the time of procedure)

Study Sites (1)

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