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

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dc.citation.firstpage321
dc.citation.issueNumber2
dc.citation.journalTitleGastroenterology
dc.citation.lastpage329
dc.citation.volumeNumber149
dc.contributor.authorProtano, Marion-Anna
dc.contributor.authorXu, Hong
dc.contributor.authorWang, Guiqi
dc.contributor.authorPolydorides, Alexandros D.
dc.contributor.authorDawsey, Sanford M.
dc.contributor.authorCui, Junsheng
dc.contributor.authorXue, Liyan
dc.contributor.authorZhang, Fan
dc.contributor.authorQuang, Timothy
dc.contributor.authorPierce, Mark C.
dc.contributor.authorShin, Dongsuk
dc.contributor.authorSchwarz, Richard A.
dc.contributor.authorBhutani, Manoop S.
dc.contributor.authorLee, Michelle
dc.contributor.authorParikh, Neil
dc.contributor.authorHur, Chin
dc.contributor.authorXu, Weiran
dc.contributor.authorMoshier, Erin
dc.contributor.authorGodbold, James
dc.contributor.authorMitcham, Josephine
dc.contributor.authorHudson, Courtney
dc.contributor.authorRichards-Kortum, Rebecca R.
dc.contributor.authorAnandasabapathy, Sharmila
dc.date.accessioned2017-06-05T21:25:24Z
dc.date.available2017-06-05T21:25:24Z
dc.date.issued2015
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.
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.
dc.identifier.doihttps://doi.org/10.1053/j.gastro.2015.04.055
dc.identifier.urihttps://hdl.handle.net/1911/94811
dc.language.isoeng
dc.publisherElsevier
dc.rightsThis is an author's peer-reviewed final manuscript, as accepted by the publisher. The published article is copyrighted by Elsevier.
dc.subject.keywordEarly Detection of Cancer
dc.subject.keywordEndoscopy
dc.subject.keywordEsophageal Neoplasm
dc.titleLow-Cost High-Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia: An International Trial
dc.typeJournal article
dc.type.dcmiText
dc.type.publicationpost-print
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