title: Low-Cost High-Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia: An International Trial.
abstract: OBJECTIVE
  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.
authors.affiliation: Division of Gastroenterology, The Mount Sinai Medical Center, New York, NY.
authors.forename: Marion-Anna
authors.initials: MA
authors.lastname: Protano
authors.affiliation: Department of Endoscopy, The First Hospital of Jilin University, Changchun, Jilin, China.
authors.forename: Hong
authors.initials: H
authors.lastname: Xu
authors.affiliation: Department of Endoscopy, Cancer Institute and Hospital, The Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Guiqi
authors.initials: G
authors.lastname: Wang
authors.affiliation: Department of Pathology, The Mount Sinai Medical Center, New York, NY.
authors.forename: Alexandros D
authors.initials: AD
authors.lastname: Polydorides
authors.affiliation: Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD.
authors.forename: Sanford M
authors.initials: SM
authors.lastname: Dawsey
authors.affiliation: Department of Pathology, The First Hospital of Jilin University, Changchun, Jilin, China.
authors.forename: Junsheng
authors.initials: J
authors.lastname: Cui
authors.affiliation: Department of Pathology, Cancer Institute and Hospital, The Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Liyan
authors.initials: L
authors.lastname: Xue
authors.affiliation: Department of Endoscopy, The First Hospital of Jilin University, Changchun, Jilin, China.
authors.forename: Fan
authors.initials: F
authors.lastname: Zhang
authors.affiliation: Department of Bioengineering, Rice University, Houston, TX.
authors.forename: Timothy
authors.initials: T
authors.lastname: Quang
authors.affiliation: Biomedical Engineering, Rutgers University, Piscataway, NJ.
authors.forename: Mark C
authors.initials: MC
authors.lastname: Pierce
authors.affiliation: Department of Bioengineering, Rice University, Houston, TX.
authors.forename: Dongsuk
authors.initials: D
authors.lastname: Shin
authors.affiliation: Department of Bioengineering, Rice University, Houston, TX.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Schwarz
authors.affiliation: Department of Gastroenterology, Hepatology and Nutrition, The University of Texas MD Anderson Cancer Center, Houston, TX.
authors.forename: Manoop S
authors.initials: MS
authors.lastname: Bhutani
authors.affiliation: Division of Gastroenterology, The Mount Sinai Medical Center, New York, NY.
authors.forename: Michelle
authors.initials: M
authors.lastname: Lee
authors.affiliation: Division of Digestive Diseases, Yale University, New Haven, CT.
authors.forename: Neil
authors.initials: N
authors.lastname: Parikh
authors.affiliation: GI Unit & Institute for Technology Assessment, Massachusetts General Hospital, Boston, MA.
authors.forename: Chin
authors.initials: C
authors.lastname: Hur
authors.affiliation: Department of Endoscopy, The First Hospital of Jilin University, Changchun, Jilin, China.
authors.forename: Weiran
authors.initials: W
authors.lastname: Xu
authors.affiliation: Department of Preventative Medicine, The Mount Sinai Medical Center, New York, NY.
authors.forename: Erin
authors.initials: E
authors.lastname: Moshier
authors.affiliation: Department of Preventative Medicine, The Mount Sinai Medical Center, New York, NY.
authors.forename: James
authors.initials: J
authors.lastname: Godbold
authors.affiliation: Division of Gastroenterology, The Mount Sinai Medical Center, New York, NY.
authors.forename: Josephine
authors.initials: J
authors.lastname: Mitcham
authors.affiliation: Division of Gastroenterology, The Mount Sinai Medical Center, New York, NY.
authors.forename: Courtney
authors.initials: C
authors.lastname: Hudson
authors.affiliation: Department of Bioengineering, Rice University, Houston, TX.
authors.forename: Rebecca R
authors.initials: RR
authors.lastname: Richards-Kortum
authors.affiliation: Division of Gastroenterology, The Mount Sinai Medical Center, New York, NY.
authors.forename: Sharmila
authors.initials: S
authors.lastname: Anandasabapathy
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001706:Biopsy; D002681:China; D055088:Early Detection of Cancer / Q000379:methods*; D004938:Esophageal Neoplasms / Q000175:diagnosis* / Q000473:pathology; D004945:Esophagoscopy / Q000379:methods*; D005260:Female; D006801:Humans; D007454:Iodides; D008297:Male; D008875:Middle Aged; D018307:Neoplasms, Squamous Cell / Q000175:diagnosis* / Q000473:pathology; D061848:Optical Imaging / Q000379:methods*; D011230:Precancerous Conditions / Q000175:diagnosis* / Q000473:pathology; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D014481:United States
chemical_list: D007454:Iodides; C010389:Lugol's solution
keywords: Early Detection of Cancer; Endoscopy; Esophageal Neoplasm