Low-cost high-resolution microendoscopy for the detection of esophageal squamous cell neoplasia: An international trial

Marion Anna Protano, Hong Xu, Guiqi Wang, Alexandros D. Polydorides, Sanford M. Dawsey, Junsheng Cui, Liyan Xue, Fan Zhang, Timothy Quang, Mark C. Pierce, Dongsuk Shin, Richard A. Schwarz, Manoop S. Bhutani, Michelle Lee, Neil Parikh, Chin Hur, Weiran Xu, Erin Moshier, James Godbold, Josephine MitchamCourtney Hudson, Rebecca R. Richards-Kortum, Sharmila Anandasabapathy

Research output: Contribution to journalArticlepeer-review

19 Scopus citations

Abstract

Background & 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.

Original languageEnglish (US)
Pages (from-to)321-329
Number of pages9
JournalGastroenterology
Volume149
Issue number2
DOIs
StatePublished - Aug 1 2015

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology

Keywords

  • Early Detection of Cancer
  • Endoscopy
  • Esophageal Neoplasm

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