Linked Color Imaging Versus Narrow Band Imaging for Colorectal Adenoma Detection

Tandem Colonoscopy Study of Linked Color Imaging Versus Narrow Band Imaging on Colorectal Adenoma Detection: A Prospective, Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Colon Adenoma
• Intervention / Treatment: Diagnostic test: Tandem colonoscopy

Detailed Description

Study design and randomization:

This is a prospective randomized head-to-head 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). All procedures are performed with high-definition endoscopes and the LASEREO endoscopic system (Fujifilm Co, Tokyo, Japan) or the EVIS- EXERA 290 video system (Olympus Optical, Tokyo, Japan).

Colonoscopy:

Patients are instructed to take low-residue diet two days before colonoscopy. Oral polyethylene glycol lavage solution is used for bowel preparation (routine bowel preparation). The assigned endoscopic system will be used and the colonoscope will advance to cecum under WL in all patients. Cecal intubation is confirmed by identification of the appendiceal orifice and ileocecal valve or by intubation of the ileum. Once cecal intubation is performed, the colonoscope is withdrawn to the anus under LCI or NBI accordingly. All detected polyps will be removed during this examination. The withdrawal time of the first pass (minus the polypectomy site) will be measured by a stopwatch.

The size (measured with biopsy forceps), location, and morphology of polyps are recorded by an independent observer. The Boston Bowel Preparation Scale score is evaluated during examination.

Immediately after the first pass examination, a second examination will be performed by the same colonoscope and the same endoscopist. The colonoscope will be reintroduced to the cecum using WL and withdraw using the previously assigned method (ie LCI or NBI). Any polyp detected on second pass examination will be removed and the withdrawal time of the second pass will also be documented. All polyp specimens are clearly labelled for histological examination.

Histologic examination All resected and biopsy specimens are fixed in 10% buffered formalin solution, and examined histologically by hematoxylin and eosin staining. The histopathological diagnosis is determined by experienced pathologists, who are blinded to the assigned endoscopic system, according to the World Health Organization (WHO) criteria.Advanced adenomas are defined as adenoma ≥10 mm in diameter or with villous histology in 25% or high-grade dysplasia (HGD), or carcinoma.

• Study Type: Interventional
• Enrollment (Actual): 272
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Queen Mary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LCI; Tandem colonoscopy with Linked Color Imaging system	Diagnostic test: Tandem colonoscopy; Different image enhanced endoscopy systems
Active Comparator: NBI; Tandem colonoscopy with Narrow band imaging system	Diagnostic test: Tandem colonoscopy; Different image enhanced endoscopy systems

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma/polyp detection rate	Percentage of patients with adenoma/polyp detected	first-pass colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma/polyp miss rate	percentage of patients with adenoma/polyp missed	second-pass colonoscopy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
advanced adenoma detection rate	percentage of patients with advanced adenoma	first-pass colonoscopy
SSA detection rate	percentage of patients with sessile serrated adenoma/polyp	first-pass colonoscopy

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Wai K Leung, MD, The University of Hong Kong

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2017
• Primary Completion (Actual): September 20, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: November 5, 2017
• First Submitted That Met QC Criteria: November 5, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: colonoscopy; image enhanced endoscopy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: LINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No