title: Safety and Feasibility of Using the Second-Generation Pillcam Colon Capsule to Assess Active Colonic Crohn's Disease.
abstract: OBJECTIVE
  The second-generation Pillcam Colon Capsule Endoscope (PCCE-2; Given Imaging Ltd, Yoqneam, Israel) is an ingestible capsule for visualization of the colon. We performed a multicenter pilot study to assess its safety and feasibility in evaluating the severity of Crohn's disease (CD).
  
  
  METHODS
  In a prospective study, 40 patients with active colonic CD underwent PCCE-2 and optical colonoscopy procedures. Using both techniques, we generated values for the Crohn's Disease Endoscopic Index of Severity (CDEIS), the Simple Endoscopic Score for CD, and global evaluation of lesion severity. In the first stage of the study, we calculated the correlation between PCCE-2 and optical colonoscopy scores. In the second stage, we performed interobserver agreement analysis for a random subset of 20 PCCE-2 recordings, graded in duplicate by 2 independent readers.
  
  
  RESULTS
  There was substantial agreement between PCCE-2 and optical colonoscopy in the measurement of the CDEIS (intraclass correlation coefficient [ICC], 0.65; 95% confidence interval [CI], 0.43-0.80). There was substantial interobserver agreement between 2 independent PCCE-2 readers for the CDEIS (ICC, 0.67; 95% CI, 0.35-0.86) and the Simple Endoscopic Score for CD (ICC, 0.66; 95% CI, 0.32-0.85). However, the PCCE-2 scoring systematically underestimated the severity of disease compared with optical colonoscopy; based on our results, PCCE-2 detected colonic ulcerations with 86% sensitivity and 40% specificity. No adverse events were observed and PCCE-2 was better tolerated than colonoscopy.
  
  
  CONCLUSIONS
  PCCE-2 is feasible, safe, and well tolerated for the assessment of mucosal CD activity in selected populations. Larger studies are needed to assess its operating characteristics further. European clinical trials database number: 2014-003854-15.
authors: Inflammatory Bowel Disease Unit, Academic Medical Centre, Amsterdam, The Netherlands; Robarts Clinical Trials, Inc, Amsterdam, The Netherlands and London, Ontario, Canada. Electronic address: g.dhaens@amc.uva.nl.
authors: Geert
authors: G
authors: D'Haens
authors: Inflammatory Bowel Disease Unit, Academic Medical Centre, Amsterdam, The Netherlands.
authors: Mark
authors: M
authors: Löwenberg
authors: Inflammatory Bowel Disease Unit, Academic Medical Centre, Amsterdam, The Netherlands; Robarts Clinical Trials, Inc, Amsterdam, The Netherlands and London, Ontario, Canada.
authors: Mark A
authors: MA
authors: Samaan
authors: Department of Gastroenterology, Hospital Erasme, Brussels, Belgium.
authors: Denis
authors: D
authors: Franchimont
authors: Inflammatory Bowel Disease Unit, Academic Medical Centre, Amsterdam, The Netherlands.
authors: Cyriel
authors: C
authors: Ponsioen
authors: Inflammatory Bowel Disease Unit, Academic Medical Centre, Amsterdam, The Netherlands.
authors: Gijs R
authors: GR
authors: van den Brink
authors: Inflammatory Bowel Disease Unit, Academic Medical Centre, Amsterdam, The Netherlands.
authors: Paul
authors: P
authors: Fockens
authors: Department of Gastroenterology, Imelda Ziekenhuis, Bonheiden, Belgium.
authors: Peter
authors: P
authors: Bossuyt
authors: Department of Gastroenterology, Hospital Erasme, Brussels, Belgium.
authors: Leila
authors: L
authors: Amininejad
authors: Robarts Clinical Trials, Inc, Amsterdam, The Netherlands and London, Ontario, Canada.
authors: Gopalan
authors: G
authors: Rajamannar
authors: Inflammatory Bowel Disease Unit, Academic Medical Centre, Amsterdam, The Netherlands.
authors: Elsemieke M
authors: EM
authors: Lensink
authors: Department of Gastroenterology, Hospital Erasme, Brussels, Belgium.
authors: Andre M
authors: AM
authors: Van Gossum
mesh_terms: D000293:Adolescent; D000328:Adult; D053705:Capsule Endoscopes / Q000009:adverse effects; D053704:Capsule Endoscopy / Q000009:adverse effects* / Q000379:methods*; D003106:Colon / Q000473:pathology*; D003424:Crohn Disease / Q000175:diagnosis* / Q000473:pathology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D055815:Young Adult
keywords: Diagnostic; Imaging; Inflammatory Bowel Disease; Monitoring