Sam Brusco, Associate Editor03.16.21
Olympus obtained FDA 510(k) clearance of Narrow Band Imaging (NBI) to evaluate colorectal polyps’ neoplastic potential. By applying the NBI International Colorectal Endoscopic (NICE) classification during a screening colonoscopy, physicians can make high-confidence predictions of histology for diminutive (5mm or smaller) polyps.
Data submitted to the FDA supporting the clearance included meta-analysis of prospective real-time clinical studies of NBI use during colonoscopy.1 The data show experienced endoscopists employing a validated classification system, such as the NICE classification, have:
Given the abundance of diminutive colorectal polyps, the American Society for Gastrointestinal Endoscopy (ASGE) recognized the importance of making real-time polyp histology predictions. ASGE created a Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) initiative to assess technologies for the ability to aid physicians in characterizing polyps. Of the technologies evaluated by ASGE's PIVI initiative, NBI was the only one shown to meet the performance criteria for incorporation in clinical practice.2
"The science behind the practice of resecting and discarding diminutive polyps identified using NBI is established," Douglas Rex, M.D. Distinguished Professor at the Indiana University School of Medicine and Director of Endoscopy at Indiana University Hospital told the press. "However, its implementation in practice has been impeded by various factors. Despite this, experts find value in interrogating lesions with NBI." Such applications include deciding whether to request pathology recuts of diminutive high-confidence adenomas deemed normal by pathology, selecting NICE type 1 lesions for endoscopic mucosal resection (EMR) and cold EMR, and facilitating accurate identification of recurrence on EMR.3
"We are excited about these newly cleared indications for using NBI to support colorectal cancer screening," said Kevin Mancini, vice president for Endoscopy at Olympus America Inc. "NBI is an important tool, available as standard on all Olympus colonoscopes, which can be used by physicians to assist in decision making with the goal of improving patient care."
NBI optical imaging technology enhances visibility and contrast of vessels and surface patterns on the mucosa. Unlike white light, which uses all colors in the spectrum, NBI filters out all but blue and green light which are absorbed by hemoglobin and penetrate only the surface of human tissue. NBI also has clinical applications in urology, pulmonology, and rhinolaryngology (ENT). Olympus also received FDA clearance for Barrett's esophagus screening and surveillance and is exploring other claims for NBI both in gynecology and general surgery.
References
1 ASGE Technology Committee, Abu Dayyeh BK, Thosani N, et al. ASGE Technology Committee systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest. Endosc. 2015;81(3):502.e1-502.e16. doi:10.1016/j.gie.2014.12.022
2 Ibid.
3 Rex DK. Narrow Band Imaging to Enhance Decision Making in Colonoscopy. Gastroenterology & Endoscopy News. 2020 Dec: 1-4.
Data submitted to the FDA supporting the clearance included meta-analysis of prospective real-time clinical studies of NBI use during colonoscopy.1 The data show experienced endoscopists employing a validated classification system, such as the NICE classification, have:
- Demonstrated 93 percent sensitivity (89-96 percent, 95 percent Confidence Interval, 59-98 percent range) in predicting adenomatous histology of diminutive polyps during colonoscopy when made with high confidence.
- Demonstrated 85 percent specificity (74-92 percent, 95 percent Confidence Interval, 44-99 percent range) in predicting adenomatous histology of diminutive polyps during colonoscopy when made with high confidence.
- Demonstrated greater than 90 percent Negative Predictive Value in predicting adenomatous histology of diminutive polyps during colonoscopy when made with high confidence.
- Achieved greater than 90 percent agreement with pathological analysis in assigning post-polypectomy patient surveillance intervals following colonoscopy.
- Were more likely to make high-confidence predictions of diminutive polyp histology when using Near Focus mode colonoscopes than those using standard focus colonoscopes.
Given the abundance of diminutive colorectal polyps, the American Society for Gastrointestinal Endoscopy (ASGE) recognized the importance of making real-time polyp histology predictions. ASGE created a Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) initiative to assess technologies for the ability to aid physicians in characterizing polyps. Of the technologies evaluated by ASGE's PIVI initiative, NBI was the only one shown to meet the performance criteria for incorporation in clinical practice.2
"The science behind the practice of resecting and discarding diminutive polyps identified using NBI is established," Douglas Rex, M.D. Distinguished Professor at the Indiana University School of Medicine and Director of Endoscopy at Indiana University Hospital told the press. "However, its implementation in practice has been impeded by various factors. Despite this, experts find value in interrogating lesions with NBI." Such applications include deciding whether to request pathology recuts of diminutive high-confidence adenomas deemed normal by pathology, selecting NICE type 1 lesions for endoscopic mucosal resection (EMR) and cold EMR, and facilitating accurate identification of recurrence on EMR.3
"We are excited about these newly cleared indications for using NBI to support colorectal cancer screening," said Kevin Mancini, vice president for Endoscopy at Olympus America Inc. "NBI is an important tool, available as standard on all Olympus colonoscopes, which can be used by physicians to assist in decision making with the goal of improving patient care."
NBI optical imaging technology enhances visibility and contrast of vessels and surface patterns on the mucosa. Unlike white light, which uses all colors in the spectrum, NBI filters out all but blue and green light which are absorbed by hemoglobin and penetrate only the surface of human tissue. NBI also has clinical applications in urology, pulmonology, and rhinolaryngology (ENT). Olympus also received FDA clearance for Barrett's esophagus screening and surveillance and is exploring other claims for NBI both in gynecology and general surgery.
References
1 ASGE Technology Committee, Abu Dayyeh BK, Thosani N, et al. ASGE Technology Committee systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest. Endosc. 2015;81(3):502.e1-502.e16. doi:10.1016/j.gie.2014.12.022
2 Ibid.
3 Rex DK. Narrow Band Imaging to Enhance Decision Making in Colonoscopy. Gastroenterology & Endoscopy News. 2020 Dec: 1-4.