NCT03746171

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

Blue Light Imaging (BLI) for Optical Diagnosis of Colorectal Polyps: the BLI Resect and Discard (BIRD) Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 324 (actual)
• Sponsor: Valduce Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Colonic Polyp

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Colonic polyp characterization by BLI	All rectosigmoid \<5 mm polyps, regardless of the presence of larger polyps, will be characterized by BLI-assisted optical diagnosis by using BASIC criteria (neoplastic vs. non neoplastic) and will be included in polyp-level assessment. The polyp characterization will be always performed and recorded without zoom magnification. In patients in which colonoscopy will be performed with endoscopes equipped with zoom magnification, the zoom will be eventually systematically applied and the characterization with zoom will be also recorded. The post-polypectomy surveillance intervals based on BLI will be calculated by using histology estimation performed without zoom for all patients. Only polyps characterized with high confidence will be included in the analysis; the high-confidence characterization rate will be calculated.

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-09-30
• Completion: 2019-10-30
• First posted: 2018-11-19
• Last updated: 2020-05-19

Locations

1 site across 1 country: Italy