Skip to main content
OpenTrials
Completed

NCT Number: NCT04831814

Narrow Band Imaging in Diagnosis of Colorectal Polyps

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Polyp Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Near Focus NBI

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

Diagnostic Test

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

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. The polyp detection rate

    Time frame: At the time of procedure

    The prevalence of patients with at least one polyp was detected

  2. The adenoma detection rate

    Time frame: At the time of procedure

    The prevalence of patients with at least one adenoma was detected

  3. Diagnostic Characteristics

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 5, 2021
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.