Narrow Band Imaging in Diagnosis of Colorectal Polyps

Colorectal Neoplasms Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04831814
• Other study ID #: 61355143
• Status: Completed
• Phase: N/A
• Start date: April 4, 2019
• Est. completion date: January 14, 2021

Study information

• Verified date: March 2021
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: January 14, 2021
• Est. primary completion date: July 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Colorectal Polyp
• Polyps

Intervention

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

Locations

Country	Name	City	State
Thailand	Prince Songkla University	Hat Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The polyp detection rate	The prevalence of patients with at least one polyp was detected	At the time of procedure
Secondary	The adenoma detection rate	The prevalence of patients with at least one adenoma was detected	At the time of procedure
Secondary	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