Narrow Band Imaging in Diagnosis of Colorectal Polyps

NCT04831814 | Completed DMC

• 1 other identifier: 61355143
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Polyp; Colorectal Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• The polyp detection rate

  At the time of procedure

• The adenoma detection rate

  At the time of procedure

• Diagnostic Characteristics

  At the time of procedure

Study Arms (2)

Near Focus NBI

EXPERIMENTAL

Use of the Near Focus NBI to make optical diagnosis

Diagnostic Test: Near Focus NBI

Standard Focus NBI

ACTIVE COMPARATOR

Use of the Standard Focus NBI to make optical diagnosis

Diagnostic Test: Standard Focus NBI

Interventions

Near Focus NBI DIAGNOSTIC_TEST

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.

Near Focus NBI

Standard Focus NBI DIAGNOSTIC_TEST

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

Standard Focus NBI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were scheduled for colonoscopy at NKC institute

You may not qualify if:

• Inflammatory bowel disease
• Polyposis syndrome
• Colorectal cancer
• Active gastrointestinal bleeding
• Pregnant woman
• Inadequate bowel preparation
• Contraindication for polyps removal

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Prince Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• NISA NETINATSUNTON, MD.

  NKC Institute of Gastroenterology and Hepatology, Prince of Songkla University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigation

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: April 4, 2019
• Primary Completion: July 2, 2020
• Study Completion: January 14, 2021
• Last Updated: May 12, 2021

Record last verified: 2021-03

Locations

TH (1)