title: Magnetically guided capsule versus conventional gastroscopy for upper abdominal complaints: a prospective blinded study.
abstract: OBJECTIVE
  Upper gastrointestinal endoscopy is mostly performed under sedation and has a low yield of relevant gastric lesions in patients without alarm symptoms. Simpler screening tests such as capsule endoscopy could be helpful, but gastric visualization is insufficient with the current passive capsules. A magnetically guided gastric capsule was prospectively evaluated in patients with routine indications for gastroscopy.
  
  
  METHODS
  A total of 189 symptomatic patients (105 male; mean age 53 y) from 2 French centers subsequently and blindly underwent capsule and conventional gastroscopy by 9 and 6 examiners, respectively. The final gold standard was unblinded conventional gastroscopy with biopsy under propofol sedation. Main outcome was accuracy (sensitivity/specificity) of capsule gastroscopy for diagnosis of major gastric lesions, defined as those lesions requiring conventional gastroscopy for biopsy or removal.
  
  
  RESULTS
  Twenty-three major lesions were found in 21 patients. Capsule accuracy was 90.5% [95% confidence interval (CI), 85.4%-94.3%] with a specificity of 94.1% (95% CI, 89.3%-97.1%) and a sensitivity of 61.9% (95% CI, 38%-82%). Accuracy did not correlate with lesion location, gastric luminal visibility, examiner case volume, or examination time. Of the remaining 168 patients, 94% had minor and mostly multiple lesions; the capsule made a correct diagnosis in 88.1% (95% CI, 82.2%-92.6%), with gastric visibility and lesion location in the proximal stomach having significant influence. All patients preferred capsule gastroscopy.
  
  
  CONCLUSIONS
  In a prospective and strictly blinded study, magnetically guided capsule gastroscopy was shown to be feasible in clinical practice and was clearly preferred by patients. Improvements in capsule technology may render this technique a future alternative to gastroscopy.
authors.affiliation: Departments of *Interdisciplinary Endoscopy #Medical Biometry and Epidemiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany †Department of Gastroenterology, Institut Arnault Tzanck, St. Laurent du Var ‡Department of Gastroenterology, Centre Hospitalier Universitaire and University of Nice Sophia Antipolis, Nice, France §Keio University School of Medicine ¶The Jikei University School of Medicine, Tokyo ∥Showa University Northern Yokohama Hospital, Yokohama, Japan.
authors.forename: Ulrike W
authors.initials: UW
authors.lastname: Denzer
authors.forename: Thomas
authors.initials: T
authors.lastname: Rösch
authors.forename: Bilal
authors.initials: B
authors.lastname: Hoytat
authors.forename: Mohammed
authors.initials: M
authors.lastname: Abdel-Hamid
authors.forename: Xavier
authors.initials: X
authors.lastname: Hebuterne
authors.forename: Geoffroy
authors.initials: G
authors.lastname: Vanbiervielt
authors.forename: Jérôme
authors.initials: J
authors.lastname: Filippi
authors.forename: Haruiko
authors.initials: H
authors.lastname: Ogata
authors.forename: Naoki
authors.initials: N
authors.lastname: Hosoe
authors.forename: Kazuo
authors.initials: K
authors.lastname: Ohtsuka
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Ogata
authors.forename: Keiichi
authors.initials: K
authors.lastname: Ikeda
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Aihara
authors.forename: Shin-Ei
authors.initials: SE
authors.lastname: Kudo
authors.forename: Hisao
authors.initials: H
authors.lastname: Tajiri
authors.forename: Andras
authors.initials: A
authors.lastname: Treszl
authors.forename: Karl
authors.initials: K
authors.lastname: Wegscheider
authors.forename: Michel
authors.initials: M
authors.lastname: Greff
authors.forename: Jean-Francois
authors.initials: JF
authors.lastname: Rey
mesh_terms: D001706:Biopsy; D053705:Capsule Endoscopes; D053704:Capsule Endoscopy / Q000295:instrumentation / Q000379:methods*; D055088:Early Detection of Cancer / Q000295:instrumentation / Q000379:methods*; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D005773:Gastroscopy / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D008280:Magnetics / Q000295:instrumentation / Q000379:methods*; D008297:Male; D008875:Middle Aged; D057240:Patient Preference; D011237:Predictive Value of Tests; D011379:Prognosis; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000175:diagnosis* / Q000473:pathology