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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04831814
Other study ID # 61355143
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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