Protano, Marion-AnnaXu, HongWang, GuiqiPolydorides, Alexandros D.Dawsey, Sanford M.Cui, JunshengXue, LiyanZhang, FanQuang, TimothyPierce, Mark C.Shin, DongsukSchwarz, Richard A.Bhutani, Manoop S.Lee, MichelleParikh, NeilHur, ChinXu, WeiranMoshier, ErinGodbold, JamesMitcham, JosephineHudson, CourtneyRichards-Kortum, Rebecca R.Anandasabapathy, Sharmila2017-06-052017-06-052015Protano, Marion-Anna, Xu, Hong, Wang, Guiqi, et al.. "Low-Cost High-Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia: An International Trial." <i>Gastroenterology,</i> 149, no. 2 (2015) Elsevier: 321-329. https://doi.org/10.1053/j.gastro.2015.04.055.https://hdl.handle.net/1911/94811Background & Aims: Esophageal squamous cell neoplasia has a high mortality rate as a result of late detection. In high-risk regions such as China, screening is performed by Lugol’s chromoendoscopy (LCE). LCE has low specificity, resulting in unnecessary tissue biopsy with a subsequent increase in procedure cost and risk. The purpose of this study was to evaluate the accuracy of a novel, low-cost, high-resolution microendoscope (HRME) as an adjunct to LCE. Methods: In this prospective trial, 147 consecutive high-risk patients were enrolled from 2 US and 2 Chinese tertiary centers. Three expert and 4 novice endoscopists performed white-light endoscopy followed by LCE and HRME. All optical images were compared with the gold standard of histopathology. Results: By using a per-biopsy analysis, the sensitivity of LCE vs LCE + HRME was 96% vs 91% (P = .0832), specificity was 48% vs 88% (P < .001), positive predictive value was 22% vs 45% (P < .0001), negative predictive value was 98% vs 98% (P = .3551), and overall accuracy was 57% vs 90% (P < .001), respectively. By using a per-patient analysis, the sensitivity of LCE vs LCE + HRME was 100% vs 95% (P = .16), specificity was 29% vs 79% (P < .001), positive predictive value was 32% vs 60%, 100% vs 98%, and accuracy was 47% vs 83% (P < .001). With the use of HRME, 136 biopsies (60%; 95% confidence interval, 53%–66%) could have been spared, and 55 patients (48%; 95% confidence interval, 38%–57%) could have been spared any biopsy. Conclusions: In this trial, HRME improved the accuracy of LCE for esophageal squamous cell neoplasia screening and surveillance. HRME may be a cost-effective optical biopsy adjunct to LCE, potentially reducing unnecessary biopsies and facilitating real-time decision making in globally underserved regions. ClinicalTrials.gov, NCT 01384708.engThis is an author's peer-reviewed final manuscript, as accepted by the publisher. The published article is copyrighted by Elsevier.Journal articleEarly Detection of CancerEndoscopyEsophageal Neoplasmhttps://doi.org/10.1053/j.gastro.2015.04.055