Linked Color Imaging Versus Narrow Band Imaging for Colorectal Adenoma Detection
Primary Purpose
Colon Adenoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tandem colonoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon Adenoma focused on measuring colonoscopy, image enhanced endoscopy
Eligibility 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
Sites / Locations
- Queen Mary Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
LCI
NBI
Arm Description
Tandem colonoscopy with Linked Color Imaging system
Tandem colonoscopy with Narrow band imaging system
Outcomes
Primary Outcome Measures
Adenoma/polyp detection rate
Percentage of patients with adenoma/polyp detected
Secondary Outcome Measures
Adenoma/polyp miss rate
percentage of patients with adenoma/polyp missed
Full Information
NCT ID
NCT03336359
First Posted
November 5, 2017
Last Updated
April 15, 2019
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03336359
Brief Title
Linked Color Imaging Versus Narrow Band Imaging for Colorectal Adenoma Detection
Official Title
Tandem Colonoscopy Study of Linked Color Imaging Versus Narrow Band Imaging on Colorectal Adenoma Detection: A Prospective, Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
September 20, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Adenoma
Keywords
colonoscopy, image enhanced endoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
272 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LCI
Arm Type
Active Comparator
Arm Description
Tandem colonoscopy with Linked Color Imaging system
Arm Title
NBI
Arm Type
Active Comparator
Arm Description
Tandem colonoscopy with Narrow band imaging system
Intervention Type
Diagnostic Test
Intervention Name(s)
Tandem colonoscopy
Intervention Description
Different image enhanced endoscopy systems
Primary Outcome Measure Information:
Title
Adenoma/polyp detection rate
Description
Percentage of patients with adenoma/polyp detected
Time Frame
first-pass colonoscopy
Secondary Outcome Measure Information:
Title
Adenoma/polyp miss rate
Description
percentage of patients with adenoma/polyp missed
Time Frame
second-pass colonoscopy
Other Pre-specified Outcome Measures:
Title
advanced adenoma detection rate
Description
percentage of patients with advanced adenoma
Time Frame
first-pass colonoscopy
Title
SSA detection rate
Description
percentage of patients with sessile serrated adenoma/polyp
Time Frame
first-pass colonoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai K Leung, MD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31276672
Citation
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.
Results Reference
derived
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Linked Color Imaging Versus Narrow Band Imaging for Colorectal Adenoma Detection
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