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

Overview

Journal Gastroenterology

Specialty Gastroenterology

Date 2015 May 19

PMID 25980753

Citations 20

Authors

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 Mitcham

Courtney Hudson

Rebecca R Richards-Kortum

Sharmila Anandasabapathy

Affiliations

Soon will be listed here.

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.

Citing Articles

A High-Resolution Microendoscope Improves Esophageal Cancer Screening and Surveillance: Implications for Underserved Global Settings Based on an International Randomized Controlled Trial.

Tan M, Li Z, Patel K, Zhang F, Yu X, Wang X Gastroenterology. 2024; 168(3):496-507.e3.

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Quantitative and comparative assessment of dyes and protocols for rapid ex vivo microscopy of fresh tissues.

Bozic I, Behr M, Brown J Sci Rep. 2024; 14(1):21376.

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Improving esophageal cancer screening across the globe: Translating knowledge into action.

Sachdeva K, Natarajan K, Iyer P Indian J Gastroenterol. 2024; 43(4):705-716.

PMID: 38848004 PMC: 11345747. DOI: 10.1007/s12664-024-01543-z.

Use of topical methylene blue to image nuclear morphometry with a low-cost scanning darkfield microendoscope.

Hou H, Carns J, Schwarz R, Gillenwater A, Anandasabapathy S, Richards-Kortum R J Biomed Opt. 2024; 29(5):050501.

PMID: 38774711 PMC: 11107336. DOI: 10.1117/1.JBO.29.5.050501.

Deep-learning-based image super-resolution of an end-expandable optical fiber probe for application in esophageal cancer diagnostics.

Zhang X, Tan M, Nabil M, Shukla R, Vasavada S, Anandasabapathy S J Biomed Opt. 2024; 29(4):046001.

PMID: 38585417 PMC: 10993061. DOI: 10.1117/1.JBO.29.4.046001.

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