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

NCT ID: NCT03274115

Last Updated: 2019-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2017-12-30

Brief 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.

Conditions

Adenoma Colon

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

White Light (WL)

White light will be used for histology prediction of colonic polyps (hyperplastic versus adenomatous).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Blue Light Imaging (BLI)

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

Group Type: ACTIVE_COMPARATOR

BLI (Blue Laser Imaging)

Intervention Type: DEVICE

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

Interventions

BLI (Blue Laser Imaging)

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valduce Hospital

OTHER

Sponsor Role: lead

Responsible Party

Franco Radaelli

MD, Head of Gastrointestinal Endoscopy Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Franco Radaelli

Role: PRINCIPAL_INVESTIGATOR

Valduce Hospital

Locations

Gastroenterology Unit, Valduce Hospital

Como, , Italy

Countries

Italy

References

Rondonotti E, Paggi S, Amato A, Mogavero G, Andrealli A, Conforti FS, Conte D, Spinzi G, Radaelli F. Blue-light imaging compared with high-definition white light for real-time histology prediction of colorectal polyps less than 1 centimeter: a prospective randomized study. Gastrointest Endosc. 2019 Mar;89(3):554-564.e1. doi: 10.1016/j.gie.2018.09.027. Epub 2018 Sep 28.

Reference Type: DERIVED

PMID: 30273590 (View on PubMed)

Other Identifiers

341/2017 bis

Identifier Type: -

Identifier Source: org_study_id