BLI, NBI or White Light Colonoscopy for Proximal Colonic Adenoma

Colon Adenoma Clinical Trial

— BNW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03696992
• Other study ID #: UW18-420
• Status: Completed
• Phase: N/A
• Start date: November 8, 2018
• Est. completion date: April 1, 2022

Study information

• Verified date: April 2022
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 884
• Est. completion date: April 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colon Adenoma

Intervention

Procedure:
• Tandem colonoscopy
Tandem colonoscopy with different image modalities

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proximal adenoma detection rate	proportion of patients with proximal adenoma detected on first examination	one day
Secondary	proximal polyp detection rate	proportion of patients with proximal polyp detected on first examination	one day
Secondary	proximal adenoma miss rate	proportion of patients with proximal adenoma detected on second examination	one day
Secondary	proximal polyp miss rate	proportion of patients with proximal polyp detected on second examination	one day