Clinical trial NCT03746171: Blue Light Imaging (BLI) for Optical Diagnosis of Colorectal Polyps
Official title: Blue Light Imaging (BLI) for Optical Diagnosis of Colorectal Polyps: the BLI Resect and Discard (BIRD) Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Polyp
Lead sponsor: Valduce Hospital
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive adult (18-80 yrs) outpatients undergoing colonoscopy in the frame of the FOBT based screening program or for CRC primary prevention, in which at least one diminutive (\<5 mm) rectosigmoid polyp is detected.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Consecutive adult (18-80 yrs) outpatients undergoing colonoscopy in the frame of the FOBT based screening program or for CRC primary prevention, in which at least one diminutive (\<5 mm) rectosigmoid polyp is detected.

Exclusion Criteria:

* patients with CRC history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer
* patients with inadequate bowel preparation
* patients in which caecal intubation was not achieved or scheduled for partial examinations
* polyps could not be resected due to ongoing anticoagulation preventing resection and pathologic assessment

Primary outcomes:
measure: Accuracy of post-polypectomy surveillance interval
timeFrame: 9 months
Secondary outcomes:
measure: Accuracy parameters of BLI polyp characterization
timeFrame: 9 months
measure: Cost analysis
timeFrame: 9 months
Other outcomes:
Locations:
city: Como
country: Italy
facility: Ospedale Valduce
Study officials:
affiliation: Valduce Hospital
name: Franco Radaelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rondonotti E, Hassan C, Andrealli A, Paggi S, Amato A, Scaramella L, Repici A, Radaelli F. Clinical Validation of BASIC Classification for the Resect and Discard Strategy for Diminutive Colorectal Polyps. Clin Gastroenterol Hepatol. 2020 Sep;18(10):2357-2365.e4. doi: 10.1016/j.cgh.2019.12.028. Epub 2020 Jan 7.