BLI, NBI or White Light Colonoscopy for Proximal Colonic Adenoma

NCT ID: NCT03696992

Last Updated: 2022-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

884 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-08

Study Completion Date

2022-04-01

Brief Summary

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This is a prospective randomised trial comparing the proximal adenoma detection rate and miss rate by blue laser imaging (BLI), narrow band imaging or white light colonoscopy.

Detailed Description

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Study population:

Consecutive adult patients, age 40 or above, undergoing outpatient colonoscopy in the Queen Mary Hospital are invited to participate in this prospective randomized study. Patients are excluded if they are unable to provide informed consent or have undergone previous colorectal resection, or have personal history of colorectal cancer, inflammatory bowel disease, familial adenomatous polyposis, Peutz-Jeghers syndrome, or other polyposis syndromes. Patients who are considered to be unsafe for polypectomy including patients with bleeding tendency and those with severe comorbid illnesses will be excluded. In addition, patients are excluded post-randomization if either the cecum could not be intubated for various reasons or Boston Bowel Preparation Scale (BBPS) score is \<2.

Study design and randomization:

This is a prospective randomized crossover trial comparing the proximal adenoma detection rate and miss rate of BLI (ELUXEO endoscopic system) vs NBI (290 video system) vs WLI which is conducted in the Endoscopy Center of the Queen Mary Hospital of Hong Kong. Eligible patients are randomly allocated to four groups in a 1:1:1 ratio to undergo tandem colonoscopy of the proximal colon, defined as cecum to splenic flexure. The three groups are: (1) NBI follow by WLI; (2) BLI follow up WLI; (3) WLI follow by WLI. 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. The patients are blinded to the group assignment.

Conditions

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Colon Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized design
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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NBI

Tandem colonoscopy with NBI follow by WL

Group Type EXPERIMENTAL

Tandem colonoscopy

Intervention Type PROCEDURE

Tandem colonoscopy with different image modalities

BLI

Tandem colonoscopy with BLI follow by WLI

Group Type ACTIVE_COMPARATOR

Tandem colonoscopy

Intervention Type PROCEDURE

Tandem colonoscopy with different image modalities

WLI

Tandem colonoscopy with WLI follow by WL

Group Type EXPERIMENTAL

Tandem colonoscopy

Intervention Type PROCEDURE

Tandem colonoscopy with different image modalities

Interventions

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Tandem colonoscopy

Tandem colonoscopy with different image modalities

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 40 or above
* scheduled for colonoscopy

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.
* Patients who are considered to be unsafe for polypectomy including patients with bleeding tendency and those with severe comorbid illnesses
* poor bowel preparation
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Queen Mary Hospital, Hong Kong

OTHER

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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LEUNG Wai Keung

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wai Keung Leung, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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Leung WK, Tsui VWM, Mak LL, Cheung MK, Hui CK, Lam CP, Wong SY, Liu KS, Ko MK, To EW, Guo CG, Lui TK. Blue-light imaging or narrow-band imaging for proximal colonic lesions: a prospective randomized tandem colonoscopy study. Gastrointest Endosc. 2023 Nov;98(5):813-821.e3. doi: 10.1016/j.gie.2023.06.004. Epub 2023 Jun 10.

Reference Type DERIVED
PMID: 37307902 (View on PubMed)

Other Identifiers

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UW18-420

Identifier Type: -

Identifier Source: org_study_id

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