BLI (Blue Light Imaging) for the Histological Characterization of Colorectal Polyps

Adenoma Colon Clinical Trial

Official title:

BLI (Blue Light Imaging) Application for the Histological Characterization of Colorectal Polyps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03274115
• Other study ID #: 341/2017 bis
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: October 2019
• Source: Valduce Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The accuracy of real-time histology prediction (hyperplastic vs. adenomas) of colonic polyps using white light high-definition endoscopes is suboptimal. Blue laser imaging (BLI) is a new system for image-enhanced endoscopy using laser light, that is incorporated in the last generation Fuji high- definition videocolonscopes ELUXEO. Blue laser imaging (BLI) utilizes two monochromatic lasers instead of xenon light: a 410 nm laser visualizes vascular microarchitecture, similar to narrow band imaging, and a 450 nm laser provides white light by excitation.This system should enhance the microvascular pattern of superficial lesions, making the histological prediction easier.

Aim of the study is to compare the accuracy of white light and BLI systems in real-time histology prediction of colonic polyps.

For this purpose all colonscopies will be performed in a standard fashion using white light. When a polyps <10mm in size will be identified, patients will be randomized in two groups. In the Group 1 (White Light Grroup), all polyps <10mm will be evaluated with white light and prediction of histology (hyperplastic versus adenomatous) will be made by means of white light. In the Group 2 (BLI Group) , all polyps <10mm in size will be evaluated with BLI and scored as hyperplastic (type 1) or adenomatous (type 2) by applying the NICE (Narrow-band Imaging International Colorectal Endoscopic) classification, indicating color/vessel/surface pattern. The level of endoscopist's confidence in predicting histology (high or low confidence) for any polyp will be also recorded.

Diagnostic performances of the endoscopists (sensitivity, specificity, positive and negative predictive values) will be calculated comparing endoscopist's prediction and pathology report, considered as reference standard in both study groups in order to evaluate the accuracy of real-time histology prediction by using BLI or white light.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 30, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All outpatients referred for colonoscopy

Exclusion Criteria:

• inadequatete bowel preparation (Boston Bowel Preparation Scale (BBPS) < 2 in one colonic segment)

• previous colonic resection

• inflammatory bowel disease

• ereditary polyposic syndromes

• patients on antithrombotics precluding polyp resection

• absence of informed consent

• inpatients or patients undergoing urgent colonscopy

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon

Intervention

Device:
• BLI (Blue Laser Imaging)
Switch from white light to BLI (Blue Laser Imaging) to predict the histology of colonic polyps

Locations

Country	Name	City	State
Italy	Gastroenterology Unit, Valduce Hospital	Como

Sponsors (1)

Lead Sponsor	Collaborator
Valduce Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performances (sensitivity, specificity, positive and negative predictive values) in predicting colonic polyp histology	Diagnostic performances (sensitivity, specificity, positive and negative predictive values) in predicting colonic polyp histology will be calculated comparing endoscopist's prediction with pathology result (reference standard).	one year