Narrow Band Imaging in Diagnosis of Colorectal Polyps

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms; Colorectal Polyp
• Intervention / Treatment: Diagnostic test: Near Focus NBI; Diagnostic test: Standard Focus NBI

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 Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Songkhla
    • Hat Yai, Songkhla, Thailand, 90110
      • Prince Songkla University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Near Focus NBI; Use of the Near Focus NBI to make optical diagnosis	Diagnostic test: 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.
Active Comparator: Standard Focus NBI; Use of the Standard Focus NBI to make optical diagnosis	Diagnostic test: Standard Focus NBI; Colonoscopy with narrow band imaging technology.Optical diagnosis of polyps were according to NICE and WASP, respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of accurate polyp histology predictions by the Endoscopists in the two groups.	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	At the time of procedure
Rate of accurate diagnosis of sessile serrated polyps/adenoma by the Endoscopists in the two groups.	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.	At the time of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The polyp detection rate	The prevalence of patients with at least one polyp was detected	At the time of procedure
The adenoma detection rate	The prevalence of patients with at least one adenoma was detected	At the time of procedure
Diagnostic Characteristics	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.	At the time of procedure

Collaborators and Investigators

• Sponsor: Prince of Songkla University
• Investigators: Principal Investigator: NISA NETINATSUNTON, MD., NKC Institute of Gastroenterology and Hepatology, Prince of Songkla University

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2019
• Primary Completion (Actual): July 2, 2020
• Study Completion (Actual): January 14, 2021

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Polyps
• Other Study ID Numbers: 61355143

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No