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

Primary Purpose

Adenoma Colon

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
BLI (Blue Laser Imaging)
Sponsored by
Valduce Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenoma Colon

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gastroenterology Unit, Valduce Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

White Light (WL)

Blue Light Imaging (BLI)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
August 29, 2017
Last Updated
October 1, 2019
Sponsor
Valduce Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03274115
Brief Title
BLI (Blue Light Imaging) for the Histological Characterization of Colorectal Polyps
Official Title
BLI (Blue Light Imaging) Application for the Histological Characterization of Colorectal Polyps
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Valduce Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma Colon

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients with at least one polyp <1 cm in size will be randomized in two groups. In the Group 1 (White Light Group), all polyps <10mm will be evaluated with white light and prediction of histology (hyperplastic versus adenomatous) will be made. 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. The level of endoscopist's confidence in predicting real-time histology (high or low confidence) for any polyp will be also recorded.
Masking
Participant
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
White Light (WL)
Arm Type
No Intervention
Arm Description
White light will be used for histology prediction of colonic polyps (hyperplastic versus adenomatous).
Arm Title
Blue Light Imaging (BLI)
Arm Type
Active Comparator
Arm Description
Switch from white light to BLI (Blue Laser Imaging) to predict the histology of colonic polyps.
Intervention Type
Device
Intervention Name(s)
BLI (Blue Laser Imaging)
Intervention Description
Switch from white light to BLI (Blue Laser Imaging) to predict the histology of colonic polyps
Primary Outcome Measure Information:
Title
Diagnostic performances (sensitivity, specificity, positive and negative predictive values) in predicting colonic polyp histology
Description
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).
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco Radaelli
Organizational Affiliation
Valduce Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastroenterology Unit, Valduce Hospital
City
Como
ZIP/Postal Code
22100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30273590
Citation
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.
Results Reference
derived

Learn more about this trial

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

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