A computer-aided device improved adenoma detection in average-risk people who underwent screening or surveillance colonoscopies for colorectal cancer (CRC), according to a randomized trial.
In a modified intention-to-treat analysis including over 1,300 patients, adenomas per colonoscopy (APC) increased with the device compared with standard colonoscopy (1.05 vs 0.83, P=0.002), as did the total number of adenomas (719 vs 562), reported Aasma Shaukat, MD, MPH, of NYU Langone Medical Center in New York City, and colleagues.
In addition, there was no significant reduction in the true histology rate with the device (67.4% vs 71.7%, respectively, P for non-inferiority <0.001), nor the total number of non-neoplastic lesions (375 vs 284, respectively). The adenoma detection rate (ADR) was 47.8% with the device and 43.9% with standard colonoscopy (P=0.065), they noted in .
Screening not only decreases CRC incidence and mortality, but also detects pre-neoplastic polyps, the authors said. Despite being highly reliable, standard colonoscopy has a . The addition of the computer-aided device can improve this rate, they added.
Shaukat and team found an increase in the detection of small lesions (1-4 mm) with the device (0.74 vs 0.88), as well as an increase in larger lesions (5-9 mm; 0.53 vs 0.68), which was "primarily driven by increased detection in the proximal colon," they wrote.
"A surprise finding was that improvement in the detection of polyps was not restricted to diminutive (<5 mm) polyps alone, but also seen in polyps 5-9 mm," Shaukat told .
The investigational device identifies colorectal polyps during high-definition white light colonoscopies using a real-time video feed with a visual indicator to assist endoscopists. The device has a 93.5% polyp-level true-positive rate and a 2.3% false-positive rate. Shaukat and colleagues previously showed that the by about 13%.
For their current study, the authors enrolled 1,359 patients ages 40 and up to undergo standard colonoscopy (n=677) or colonoscopy with the device (n=682) from January to September 2021 across five centers. Patients were excluded if they had a history of inflammatory bowel disease, a diagnostic indication for colonoscopy, or familial adenomatous polyposis.
There were no significant differences in patient characteristics or clinical features between groups. Average age was 60 to 61, and 52-54% were men. Nearly all were white. Both arms had a minimal withdrawal time of 8 minutes, and the average procedure time was 15.4-15.8 minutes.
Colonoscopies were performed by 22 experienced gastroenterologists, who had a minimum ADR of 25%.
Overall, 173 additional polyps were resected in the device group versus the standard group (1,136 vs 963).
Among patients who underwent screening exams, the device group had an absolute increase in APC of 0.19 (0.85 vs 0.67 with standard screening, P=0.018) and an increase of 2.9% in ADR (41.3% vs 38.4%, respectively, P=0.176). Among those who underwent surveillance exams, the absolute increase in APC was 0.25 (1.41 vs 1.17, respectively, P=0.061) and 4.2% in ADR (59.4% vs 55.2%, respectively, P=0.196).
Use of the device led to a significant increase in the number of polyps resected in the proximal colon, but not the distal colon.
Shaukat and colleagues noted that their study lacked long-term follow-up. Furthermore, findings may not be generalizable to patients who are not at average risk.
Disclosures
This study was supported by Iterative Scopes.
Shaukat reported relationships with Freenome Inc., Iterative Scopes, and Medtronic.
Co-authors disclosed relationships with Ambu, Harvard Medical School, Olympus America Inc., and Iterative Scopes (including stock, employment, serving on the advisory board, and consulting fees).
Primary Source
Gastroenterology
Shaukat A, et al "Computer-aided detection improves adenomas per colonoscopy for screening and surveillance colonoscopy: a randomized trial" Gastroenterology 2022; DOI: 10.1053/j.gastro.2022.05.028.