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Linked Color Imaging Versus Narrow Band Imaging for Colorectal Adenoma Detection

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ClinicalTrials.gov Identifier: NCT03336359
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
LEUNG Wai Keung, The University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
Colon Adenoma Diagnostic Test: Tandem colonoscopy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Tandem Colonoscopy Study of Linked Color Imaging Versus Narrow Band Imaging on Colorectal Adenoma Detection: A Prospective, Randomized Study
Actual Study Start Date : October 23, 2017
Actual Primary Completion Date : September 20, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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




Primary Outcome Measures :
  1. Adenoma/polyp detection rate [ Time Frame: first-pass colonoscopy ]
    Percentage of patients with adenoma/polyp detected


Secondary Outcome Measures :
  1. Adenoma/polyp miss rate [ Time Frame: second-pass colonoscopy ]
    percentage of patients with adenoma/polyp missed


Other Outcome Measures:
  1. advanced adenoma detection rate [ Time Frame: first-pass colonoscopy ]
    percentage of patients with advanced adenoma

  2. SSA detection rate [ Time Frame: first-pass colonoscopy ]
    percentage of patients with sessile serrated adenoma/polyp



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03336359


Contacts
Contact: Wai K Leung, MD 852 22553348 waikleung@hku.hk
Contact: Teresa Tong 852 22551674 tongsma@hku.hk

Locations
China
Queen Mary Hospital Recruiting
Hong Kong, China
Contact: Wai Keung Leung, MD    85222553750      
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Wai K Leung, MD The University of Hong Kong

Responsible Party: LEUNG Wai Keung, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03336359     History of Changes
Other Study ID Numbers: LINA
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by LEUNG Wai Keung, The University of Hong Kong:
colonoscopy
image enhanced endoscopy

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms