Linked Color Imaging Versus Narrow Band Imaging for Colorectal Adenoma Detection

NCT03336359 | Completed

• 1 other identifier: LINA
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized trial comparing the adenoma detection rate of LCI with NBI. Eligible patients are randomly allocated in a 1:1 ratio to undergo tandem colonoscopy with LCI (LCI group) or NBI (NBI group). Randomization will be carried out by computer generated random sequences and stratified according to endoscopist's experiences (experienced versus fellows) and indications of colonoscopy (symptomatic vs screening/surveillance). The primary outcome of this study is to compare the adenoma or polyp detection rates by LCI and NBI during the first examination. Secondary outcomes included adenoma/polyp miss rate by LCI or NBI. Other outcomes include sessile serrated adenomas or polyps (SSA/P) detection rates and advanced adenoma detection rates.

Conditions

Colon Adenoma

Keywords

colonoscopy; image enhanced endoscopy

Outcome Measures

Primary Outcomes (1)

• Adenoma/polyp detection rate

  Percentage of patients with adenoma/polyp detected

  first-pass colonoscopy

Secondary Outcomes (1)

• Adenoma/polyp miss rate

  second-pass colonoscopy

Other Outcomes (2)

• advanced adenoma detection rate

  first-pass colonoscopy

• SSA detection rate

  first-pass colonoscopy

Study Arms (2)

LCI

ACTIVE COMPARATOR

Tandem colonoscopy with Linked Color Imaging system

Diagnostic Test: Tandem colonoscopy

NBI

ACTIVE COMPARATOR

Tandem colonoscopy with Narrow band imaging system

Diagnostic Test: Tandem colonoscopy

Interventions

Tandem colonoscopy DIAGNOSTIC_TEST

Different image enhanced endoscopy systems

LCI; NBI

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive adult patients undergoing outpatient colonoscopy
• aged 40 or above

You may not qualify if:

• unable to provide informed consent
• have undergone previous colorectal resection
• personal history of colorectal cancer, inflammatory bowel disease, familial adenomatous polyposis, Peutz-Jeghers syndrome, or other polyposis syndromes
• considered to be unsafe for polypectomy including patients with bleeding tendency and those with severe comorbid illnesses
• cecum could not be intubated for various reasons or due to poor bowel preparation

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, China

Location

Related Publications (1)

• Leung WK, Guo CG, Ko MKL, To EWP, Mak LY, Tong TSM, Chen LJ, But DYK, Wong SY, Liu KSH, Tsui V, Lam FYF, Lui TKL, Cheung KS, Lo SH, Hung IFN. Linked color imaging versus narrow-band imaging for colorectal polyp detection: a prospective randomized tandem colonoscopy study. Gastrointest Endosc. 2020 Jan;91(1):104-112.e5. doi: 10.1016/j.gie.2019.06.031. Epub 2019 Jul 2.

  PMID: 31276672 DERIVED

Study Officials

• Wai K Leung, MD

  The University of Hong Kong

  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: Professor

Study Record Dates

• First Submitted: November 5, 2017
• First Posted: November 8, 2017
• Study Start: October 23, 2017
• Primary Completion: September 20, 2018
• Study Completion: December 31, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)