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Narrow Band Imaging in Diagnosis of Colorectal Polyps

P

Prince of Songkla University

Status

Completed

Conditions

Colorectal Polyp
Colorectal Neoplasms

Treatments

Diagnostic Test: Standard Focus NBI
Diagnostic Test: Near Focus NBI

Study type

Interventional

Funder types

Other

Identifiers

NCT04831814
61355143

Details and patient eligibility

About

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.

Full 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.

Enrollment

118 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

118 participants in 2 patient groups

Near Focus NBI
Experimental group
Description:
Use of the Near Focus NBI to make optical diagnosis
Treatment:
Diagnostic Test: Near Focus NBI
Standard Focus NBI
Active Comparator group
Description:
Use of the Standard Focus NBI to make optical diagnosis
Treatment:
Diagnostic Test: Standard Focus NBI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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