Background & Aims
High-resolution microendoscopy is an optical imaging technique with the
potential to improve the accuracy of endoscopic screening for esophageal squamous
neoplasia. Although these microscopic images can readily be interpreted by trained
personnel, quantitative image analysis software could facilitate the use of this
technology in low-resource settings. In this study we developed and evaluated
quantitative image analysis criteria for the evaluation of neoplastic and non-neoplastic
squamous esophageal mucosa.
Methods
We performed image analysis of 177 patients undergoing standard upper endoscopy
for screening or surveillance of esophageal squamous neoplasia, using high-resolution
microendoscopy, at 2 hospitals in China and 1 in the United States from May 2010 to
October 2012. Biopsies were collected from imaged sites (n=375); a consensus diagnosis
was provided by 2 expert gastrointestinal pathologists and used as the standard.
Results
Quantitative information from the high-resolution images was used to develop an
algorithm to identify high-grade squamous dysplasia or invasive squamous cell cancer,
based on histopathology findings. Optimal performance was obtained using mean nuclear
area as the basis for classification, resulting in sensitivities and specificities of
93% and 92% in the training set, 87% and 97% in the test
set, and 84% and 95% in an independent validation set, respectively.
Conclusions
High-resolution microendoscopy with quantitative image analysis can aid in the
identification of esophageal squamous neoplasia. Use of software-based image guides may
overcome issues of training and expertise in low-resource settings, allowing for
widespread use of these optical biopsy technologies.
Background and Aims
Esophageal squamous cell neoplasia (ESCN) has high mortality due to 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 subsequent increase in procedure cost and risk. The purpose of this study is 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 two US and two Chinese tertiary centers. Three expert and four novice endoscopists performed white light endoscopy followed by LCE and HRME. All optical images were compared to gold standard of histopathology.
Results
Using a per biopsy analysis, sensitivity of LCE vs. LCE + HRME was 96% vs. 91% (p=0.0832), specificity 48% vs. 88% (p<0.001), PPV 22% vs 45% (p<0.0001), NPV 98% vs. 98% (p=0.3551), and overall accuracy 57% vs. 90% (p<0.001). Using a per patient analysis, sensitivity of LCE vs. LCE + HRME was 100% vs. 95% (p=0.16), specificity 29% vs. 79% (p<0.001), PPV 32% vs. 60%, 100% vs. 98%, and accuracy 47% vs. 83% (p<0.001). With use of HRME, 136 biopsies (60%; 95% CI: 53-66%) could have been spared, and 55 patients (48%; 95% CI: 38-57%) spared any biopsy.
Conclusion
In this trial, HRME improved the accuracy of LCE for ESCN screening and surveillance. HRME may be a cost-effective “optical” biopsy adjunct to LCE, potentially reducing unnecessary biopsy and facilitating real-time decision-making in globally underserved regions; ClinicalTrials.gov, NCT 01384708.
Summary
The high-resolution microendoscope (HRME) is a novel imaging modality that may be useful in the surveillance of Barrett's esophagus in low-resource or community-based settings. In order to assess accuracy and interrater reliability of microendoscopists in identifying Barrett's-associated neoplasia using HRME images, we recruited 20 gastroenterologists with no microendoscopic experience and three expert microendoscopists in a large academic hospital in New York City to interpret HRME images. They prospectively reviewed 40 HRME images from 28 consecutive patients undergoing surveillance for metaplasia and low-grade dysplasia and/or evaluation for high-grade dysplasia or cancer. Images were reviewed in a blinded fashion, after a 4-minute training with 11 representative images. All imaged sites were biopsied and interpreted by an expert pathologist. Sensitivity of all endoscopists for identification of high-grade dysplasia or cancer was 0.90 (95% confidence interval [CI]: 0.88–0.92) and specificity was 0.82 (95% CI: 0.79–0.85). Positive and negative predictive values were 0.72 (95% CI: 0.68–0.77) and 0.94 (95% CI: 0.92–0.96), respectively. No significant differences in accuracy were observed between experts and novices (0.90 vs. 0.84). The kappa statistic for all raters was 0.56 (95% CI: 0.54–0.58), and the difference between groups was not significant (0.64 vs. 0.55). These data suggest that gastroenterologists can diagnose Barrett's-related neoplasia on HRME images with high sensitivity and specificity, without the aid of prior microendoscopy experience.
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