BLI, NBI or White Light Colonoscopy for Proximal Colonic Adenoma

Sponsor:

Collaborators:

Information provided by (Responsible Party):

LEUNG Wai Keung，The University of Hong Kong

Tracking Information

First Submitted Date ^ICMJE

September 27, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 4, 2018

Estimated Primary Completion Date

September 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proximal adenoma detection rate[ Time Frame: one day ]

proportion of patients with proximal adenoma detected

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

proximal polyp detection rate[ Time Frame: one day ]
proportion of patients with proximal polyp detected
proximal adenoma miss rate[ Time Frame: one day ]
proportion of patients with proximal adenoma detected
proximal polyp miss rate[ Time Frame: one day ]
proportion of patients with proximal polyp detected

Descriptive Information

Brief Title ^ICMJE

BLI, NBI or White Light Colonoscopy for Proximal Colonic Adenoma

Official Title ^ICMJE

Blue Laser Imaging Versus Narrow Band Imaging Versus White Light Imaging for Detection of Adenoma in the Proximal Colon: A Prospective, Randomized, Crossover Study

Brief Summary

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

Detailed Description

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 were 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 (LASEREO endoscopic system) vs NBI (EXERA 290 video system) vs WLI (Fig.1) 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 1:1:1:1 ratio to undergo tandem colonoscopy of the proximal colon, defined as cecum to splenic flexure. The four groups are: (1) NBI (290) follow by WLI; (2) WLI follow up NBI (290); (3) BLI (LASEREO) follow by WLI; (4) WLI follow by BLI (LASEREO) in blocks of 8 (Figure 1). 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) for BLI or the EVIS- EXERA 290 video system for NBI (Olympus Optical, Tokyo, Japan). The patients are blinded to the group assignment.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Prospective randomized cross-over design
Masking: Interventional
Masking Description:
Primary Purpose: Diagnostic

Condition ^ICMJE

Intervention ^ICMJE

Procedure: Tandem colonoscopy
Tandem colonoscopy with different image modalities

Study Arms

Experimental: NBI_WL
Tandem colonoscopy with NBI follow by WL
Active Comparator: WLI_NBI
Tandem colonoscopy with WLI follow by NBI
Experimental: BLI_WL
Tandem colonoscopy with BLI follow by WL
Active Comparator: WL_BLI
Tandem colonoscopy with WL follow by BLI

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1200

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 31, 2020

Estimated Primary Completion Date

September 30, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

40 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Hong Kong

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

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

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

LEUNG Wai Keung，The University of Hong Kong

Study Sponsor ^ICMJE

The University of Hong Kong

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Wai Keung Leung, MD The University of Hong Kong

PRS Account

The University of Hong Kong

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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