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Narrow Band Imaging in Diagnosis of Colorectal Polyps

Primary Purpose

Colorectal Polyp, Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Near Focus NBI
Standard Focus NBI
Sponsored by
Prince of Songkla University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Polyp

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prince Songkla University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Near Focus NBI

Standard Focus NBI

Arm Description

Use of the Near Focus NBI to make optical diagnosis

Use of the Standard Focus NBI to make optical diagnosis

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

The polyp detection rate
The prevalence of patients with at least one polyp was detected
The adenoma detection rate
The prevalence of patients with at least one adenoma was detected
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.

Full Information

First Posted
April 1, 2021
Last Updated
May 11, 2021
Sponsor
Prince of Songkla University
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1. Study Identification

Unique Protocol Identification Number
NCT04831814
Brief Title
Narrow Band Imaging in Diagnosis of Colorectal Polyps
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 4, 2019 (Actual)
Primary Completion Date
July 2, 2020 (Actual)
Study Completion Date
January 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Polyp, Colorectal Neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Near Focus NBI
Arm Type
Experimental
Arm Description
Use of the Near Focus NBI to make optical diagnosis
Arm Title
Standard Focus NBI
Arm Type
Active Comparator
Arm Description
Use of the Standard Focus NBI to make optical diagnosis
Intervention Type
Diagnostic Test
Intervention Name(s)
Near Focus NBI
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Standard Focus NBI
Intervention Description
Colonoscopy with narrow band imaging technology.Optical diagnosis of polyps were according to NICE and WASP, respectively.
Primary Outcome Measure Information:
Title
Rate of accurate polyp histology predictions by the Endoscopists in the two groups.
Description
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
Time Frame
At the time of procedure
Title
Rate of accurate diagnosis of sessile serrated polyps/adenoma by the Endoscopists in the two groups.
Description
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.
Time Frame
At the time of procedure
Secondary Outcome Measure Information:
Title
The polyp detection rate
Description
The prevalence of patients with at least one polyp was detected
Time Frame
At the time of procedure
Title
The adenoma detection rate
Description
The prevalence of patients with at least one adenoma was detected
Time Frame
At the time of procedure
Title
Diagnostic Characteristics
Description
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.
Time Frame
At the time of procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NISA NETINATSUNTON, MD.
Organizational Affiliation
NKC Institute of Gastroenterology and Hepatology, Prince of Songkla University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince Songkla University
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

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Narrow Band Imaging in Diagnosis of Colorectal Polyps

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