Low-Cost High-Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia: An International Trial

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dc.citation.firstpage321en_US
dc.citation.issueNumber2en_US
dc.citation.journalTitleGastroenterologyen_US
dc.citation.lastpage329en_US
dc.citation.volumeNumber149en_US
dc.contributor.authorProtano, Marion-Annaen_US
dc.contributor.authorXu, Hongen_US
dc.contributor.authorWang, Guiqien_US
dc.contributor.authorPolydorides, Alexandros D.en_US
dc.contributor.authorDawsey, Sanford M.en_US
dc.contributor.authorCui, Junshengen_US
dc.contributor.authorXue, Liyanen_US
dc.contributor.authorZhang, Fanen_US
dc.contributor.authorQuang, Timothyen_US
dc.contributor.authorPierce, Mark C.en_US
dc.contributor.authorShin, Dongsuken_US
dc.contributor.authorSchwarz, Richard A.en_US
dc.contributor.authorBhutani, Manoop S.en_US
dc.contributor.authorLee, Michelleen_US
dc.contributor.authorParikh, Neilen_US
dc.contributor.authorHur, Chinen_US
dc.contributor.authorXu, Weiranen_US
dc.contributor.authorMoshier, Erinen_US
dc.contributor.authorGodbold, Jamesen_US
dc.contributor.authorMitcham, Josephineen_US
dc.contributor.authorHudson, Courtneyen_US
dc.contributor.authorRichards-Kortum, Rebecca R.en_US
dc.contributor.authorAnandasabapathy, Sharmilaen_US
dc.contributor.orgBioengineeringen_US
dc.date.accessioned2017-06-05T21:25:24Zen_US
dc.date.available2017-06-05T21:25:24Zen_US
dc.date.issued2015en_US
dc.description.abstractBackground & 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.en_US
dc.identifier.citationProtano, 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.en_US
dc.identifier.doihttps://doi.org/10.1053/j.gastro.2015.04.055en_US
dc.identifier.urihttps://hdl.handle.net/1911/94811en_US
dc.language.isoengen_US
dc.publisherElsevieren_US
dc.rightsThis is an author's peer-reviewed final manuscript, as accepted by the publisher. The published article is copyrighted by Elsevier.en_US
dc.subject.keywordEarly Detection of Canceren_US
dc.subject.keywordEndoscopyen_US
dc.subject.keywordEsophageal Neoplasmen_US
dc.titleLow-Cost High-Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia: An International Trialen_US
dc.typeJournal articleen_US
dc.type.dcmiTexten_US
dc.type.publicationpost-printen_US
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