NCT03746171: BIRD

Blue Light Imaging (BLI) for Optical Diagnosis of Colorectal Polyps

Completed Last updated 19 May 2020

What this trial tests

trial testing Colonic polyp characterization by BLI in Colonic Polyp in 324 participants. Completed in 30 October 2019.

Timeline

1 January 2019

Primary endpoint
30 September 2019

30 October 2019

Quick facts

Lead sponsor	Valduce Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	324
Start date	1 January 2019
Primary completion	30 September 2019
Estimated completion	30 October 2019
Sites	1 location across Italy

Drugs / interventions tested

• Colonic polyp characterization by BLI

Conditions studied

• Colonic Polyp — all drugs for Colonic Polyp →

Sponsor

Valduce Hospital

Who can join

Adults 18 to 80, any sex, with Colonic Polyp. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Several imaging technologies have been developed in order to enable the endoscopists to differentiate neoplastic from non-neoplastic lesions. The real-time prediction of polyps histology is clinically relevant as diminutive polyps represent the majority of polyps detected during colonoscopy and have a very low risk of harboring advanced histology or invasive carcinoma. Thus, an optical diagnosis would allow diminutive polyps to be resected and discarded without pathological assessment or left in place without resection, with an enormous cost-saving potential. Recently, the American Society of Gastrointestinal Endoscopy (ASGE) has set the Preservation and Incorporation of Valuable endoscopic Innovation (PIVI) which defined accuracy threshold to be met, in order to consider a new technology ready to be incorporate into clinical practice. Blue Light Imaging (BLI) is a new chromoendoscopy technology integrated in the latest generation ELUXEOTM 7000 endoscopy platform (Fujifilm Co, Tokyo, Japan), based on the direct (i.e. not filtered) emission of blue light with short wavelength (410nm), that enhances visibility of both microvascular and superficial mucosal pattern. In a recent randomized trial BLI was superior to high-definition white light (HDWL) in the real time characterization of subcentimetric and diminutive colonic polyps. Nevertheless, in this study the paucity of diminutive rectosigmoid polyps analyzed does not allow to draw definite conclusions as the meeting of PIVI thresholds are concerned. Similarly, the low numbers of patients evaluated limited the per-patient analysis. Therefore further studies adequately powered to this clinically end-point were advocated. Additionally, when the study was performed a BLI dedicated classification for optical diagnosis of colonic polyps was not available, whereas recently a specific classification (the BLI Adenoma Serrated International Classification-BASIC) has been developed and a specific training set has been settled.

In the present study the investigators prospectively evaluate whether the use of BLI-assisted optical characterization of diminutive polyps using BASIC classification by specifically trained endoscopists may met PIVI thresholds and particularly if it allow the endoscopists to achieve \> 90% correct assignment of post-polypectomy surveillance intervals when combined with the histopathology assessment of polyps \>5 mm in size.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical Validation of BASIC Classification for the Resect and Discard Strategy for Diminutive Colorectal Polyps.
   Rondonotti E, Hassan C, Andrealli A, Paggi S, et al · · 2020 · cited 15× · PMID 31923641 · DOI 10.1016/j.cgh.2019.12.028