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

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. ClinicalTrials.gov, NCT 01384708.

Trial registration: ClinicalTrials.gov NCT01384708.

Keywords: Early Detection of Cancer; Endoscopy; Esophageal Neoplasm.

Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1

(A) Device configuration. (B) The device is battery operated and easily fits in a briefcase. (C) To facilitate objective, real-time assessment of nuclear size and spacing, a grid with 19.4 μm spacing was superimposed on the display monitor and 15.1 μm diameter dots were placed; this image is normal esophageal mucosa.

Figure 2

Lugol's unstained areas are imaged with HRME and an ‘optical biopsy’ is obtained with the corresponding tissue biopsy (original magnification 100x) of the area. Only one of the two Lugol's “abnormal” areas was neoplastic (upper panel).

Figure 3

Comparison of total number of mucosal biopsies obtained and total number of patients requiring a biopsy with LCE versus LCE + HRME