Marion-Anna Protano1, Hong Xu2, Guiqi Wang3, Rebecca R Richards-Kortum4, Sharmila Anandasabapathy1, Alexandros D Polydorides5, Sanford M Dawsey6, Junsheng Cui7, Liyan Xue8, Fan Zhang2, Timothy Quang4, Mark C Pierce9, Dongsuk Shin4, Richard A Schwarz4, Manoop S Bhutani10, Michelle Lee1, Neil Parikh11, Chin Hur12, Weiran Xu2, Erin Moshier13, James Godbold13, Josephine Mitcham1, Courtney Hudson1. 1. Division of Gastroenterology, The Mount Sinai Medical Center, New York, NY. 2. Department of Endoscopy, The First Hospital of Jilin University, Changchun, Jilin, China. 3. Department of Endoscopy, Cancer Institute and Hospital, The Chinese Academy of Medical Sciences, Beijing, China. 4. Department of Bioengineering, Rice University, Houston, TX. 5. Department of Pathology, The Mount Sinai Medical Center, New York, NY. 6. Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD. 7. Department of Pathology, The First Hospital of Jilin University, Changchun, Jilin, China. 8. Department of Pathology, Cancer Institute and Hospital, The Chinese Academy of Medical Sciences, Beijing, China. 9. Biomedical Engineering, Rutgers University, Piscataway, NJ. 10. Department of Gastroenterology, Hepatology and Nutrition, The University of Texas MD Anderson Cancer Center, Houston, TX. 11. Division of Digestive Diseases, Yale University, New Haven, CT. 12. GI Unit & Institute for Technology Assessment, Massachusetts General Hospital, Boston, MA. 13. Department of Preventative Medicine, The Mount Sinai Medical Center, New York, NY.
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.
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.
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