Optical diagnosis of colorectal polyps: a randomized controlled trial comparing endoscopic image-enhancing modalities

Abstract

Background and aims: Optical polyp diagnosis using image-enhanced endoscopy (IEE) allows for real-time histology prediction of colorectal polyps. The aim of this study was to evaluate a recently introduced IEE modality (Optivista [OV]; Pentax Medical, Tokyo, Japan) in a randomized controlled trial.

Methods: In a prospective cohort of subjects (ages 45-80 years) undergoing elective screening, surveillance, or diagnostic colonoscopy, all colorectal polyps between 1 and 5 mm underwent IEE assessment. Study subjects were randomized before their colonoscopy procedure to undergo optical polyp diagnosis using either OV IEE or iScan (IS) IEE. A validated IEE scale (NBI International Colorectal Endoscopic classification) was used for optical polyp diagnosis. The primary outcome was the agreement of surveillance intervals determined when using OV IEE compared with IS IEE in reference with pathology-based surveillance intervals. Secondary outcomes were the percentage of surveillance intervals that could be given on the same day as the procedure, percentage of pathology tests avoided, diagnostic performance, and negative predictive value (NPV) of optical diagnosis for rectosigmoid adenomas.

Results: Four hundred ten patients were enrolled in the trial. The polyp detection rate was 58.6%, and the adenoma detection rate was 38.8%. The proportion of correct surveillance interval assignment when using OV or IS IEE was 96.5% versus 96.0% (P = .75). A total of 65.1% of patients could be given same-day surveillance intervals when using OV IEE versus 73.1% for IS IEE (P = .07). The NPV for rectosigmoid adenomas (including sessile serrated adenomas) was 97.5% when using OV IEE and 88.2% when using IS IEE. Using high-confidence optical diagnosis instead of pathology would have resulted in a 44.3% elimination of required pathology examinations for OV IEE versus 52.8% for IS IEE (P = .34).

Conclusions: Optical diagnosis using OV and IS IEE both surpassed the 90% benchmark of surveillance interval assignment, and no significant difference with regard to correct surveillance interval assignment was found. OV IEE surpassed the ≥90% NPV for rectosigmoid adenomas, whereas IS IEE did not. (Clinical trial registration number: NCT03515343.).