Colon Adenoma Clinical Trial
Official title:
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 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is performed, the colonoscope is withdrawn to the anus under LCI or NBI accordingly.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.
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