Narrow Band Imaging in Diagnosis of Colorectal Polyps

• ClinicalTrials.gov Identifier: NCT04831814
• Recruitment Status: Completed
• First Posted: April 5, 2021
• Last Update Posted: May 12, 2021
• Sponsor: Prince of Songkla University
• Information provided by (Responsible Party): Nisa Netinatsunton, Prince of Songkla University

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.

Condition or disease	Intervention/treatment	Phase
Colorectal Polyp; Colorectal Neoplasms	Diagnostic Test: Near Focus NBI; Diagnostic Test: Standard Focus NBI	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Actual Study Start Date: April 4, 2019
• Actual Primary Completion Date: July 2, 2020
• Actual Study Completion Date: January 14, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Near Focus NBI; Use of the Near Focus NBI to make optical diagnosis	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.
Active Comparator: Standard Focus NBI; Use of the Standard Focus NBI to make optical diagnosis	Diagnostic Test: Standard Focus NBI; Colonoscopy with narrow band imaging technology.Optical diagnosis of polyps were according to NICE and WASP, respectively.

Outcome Measures

Primary Outcome Measures :

1. Rate of accurate polyp histology predictions by the Endoscopists in the two groups. [ Time Frame: At the time of procedure ]
   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
2. Rate of accurate diagnosis of sessile serrated polyps/adenoma by the Endoscopists in the two groups. [ Time Frame: At the time of procedure ]
   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 :

1. The polyp detection rate [ Time Frame: At the time of procedure ]
   The prevalence of patients with at least one polyp was detected
2. The adenoma detection rate [ Time Frame: At the time of procedure ]
   The prevalence of patients with at least one adenoma was detected
3. Diagnostic Characteristics [ Time Frame: At the time of procedure ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Thailand

Prince Songkla University

Hat Yai, Songkhla, Thailand, 90110

Sponsors and Collaborators

Prince of Songkla University

Investigators

• Principal Investigator: NISA NETINATSUNTON, MD.; NKC Institute of Gastroenterology and Hepatology, Prince of Songkla University

More Information

• Responsible Party: Nisa Netinatsunton, Principal Investigation, Prince of Songkla University
• ClinicalTrials.gov Identifier: NCT04831814
• Other Study ID Numbers: 61355143
• First Posted: April 5, 2021
• Last Update Posted: May 12, 2021
• Last Verified: March 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Colorectal Neoplasms; Polyps; Pathological Conditions, Anatomical; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases