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

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ClinicalTrials.gov Identifier: NCT03274115
Recruitment Status : Recruiting
First Posted : September 6, 2017
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Franco Radaelli, Valduce Hospital

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.


Condition or disease Intervention/treatment Phase
Adenoma Colon Device: BLI (Blue Laser Imaging) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Participant)
Primary Purpose: Diagnostic
Official Title: BLI (Blue Light Imaging) Application for the Histological Characterization of Colorectal Polyps
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: White Light (WL)
White light will be used for histology prediction of colonic polyps (hyperplastic versus adenomatous).
Active Comparator: Blue Light Imaging (BLI)
Switch from white light to BLI (Blue Laser Imaging) to predict the histology of colonic polyps.
Device: BLI (Blue Laser Imaging)
Switch from white light to BLI (Blue Laser Imaging) to predict the histology of colonic polyps




Primary Outcome Measures :
  1. Diagnostic performances (sensitivity, specificity, positive and negative predictive values) in predicting colonic polyp histology [ Time Frame: one year ]
    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).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274115


Contacts
Contact: Franco Radaelli, MD 0039031324146 francoradaelli01@gmail.com

Locations
Italy
Gastroenterology Unit, Valduce Hospital Recruiting
Como, Italy, 22100
Contact: Franco Radaelli, MD    0039031324145    francoradaelli01@gmail.com   
Sponsors and Collaborators
Valduce Hospital
Investigators
Principal Investigator: Franco Radaelli Valduce Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Franco Radaelli, MD, Head of Gastrointestinal Endoscopy Unit, Valduce Hospital
ClinicalTrials.gov Identifier: NCT03274115     History of Changes
Other Study ID Numbers: 341/2017 bis
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms