Gil Y Melmed1, Marla C Dubinsky2, David T Rubin3, Mark Fleisher4, Shabana F Pasha5, Atsushi Sakuraba3, Felix Tiongco6, Ira Shafran7, Ignacio Fernandez-Urien8, Bruno Rosa9, Neofytos P Papageorgiou10, Jonathan A Leighton5. 1. F Widjaja Inflammatory Bowel and Immunobiology Research Institute, Cedars Sinai Medical Center, Los Angeles, California, USA. 2. Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Mount Sinai Hospital, New York, New York, USA. 3. Inflammatory Bowel Disease Center, The University of Chicago Medicine, Chicago, Illinois, USA. 4. Division of Hepatology and Gastroenterology, Borland-Groover Clinic, Jacksonville, Florida, USA. 5. Division of Gastroenterology and Hepatology, Mayo Clinic Arizona, Scottsdale, Arizona, USA. 6. Clinical Research Division, Gastroenterology Associates of Tidewater, Chesapeake, Virginia, USA. 7. Shafran Gastroenterology Research Center, Winter Park, Florida, USA. 8. Department of Gastroenterology, Hospital de Navarra, Navarra, Spain. 9. Department of Gastroenterology, Hospital da Senhora da Oliveira, Guimarães, Portugal. 10. Department of Gastroenterology, American Medical Center, Nicosia, Cyprus.
Abstract
BACKGROUND AND AIMS: This prospective, multicenter study evaluated small-bowel capsule endoscopy (CE) for the longitudinal assessment of mucosal inflammation in subjects with Crohn's disease (CD). METHODS: Subjects with known CD underwent clinical evaluation with ileocolonoscopy and CE at baseline and 6-month follow-up. Small-bowel patency was confirmed before CE at both time points. The Simple Endoscopic Score for CD (SES-CD) was used for ileocolonoscopy, and the Lewis score and the CE CD Endoscopic Index of Severity (CECDEIS) were used for CE. Clinical scoring indices included the Physician Global Assessment (PGA), CD Activity Index (CDAI), and Harvey-Bradshaw Index (HBI). Laboratory markers including C-reactive protein, fecal calprotectin, and erythrocyte sedimentation rate were collected at baseline and follow-up. Correlation between endoscopic scores and clinical parameters were measured using Spearman tests. RESULTS: A total of 74 subjects were enrolled, of whom 53 (72%) completed endoscopic procedures at baseline and 6-month follow-up. The SES-CD ileocolonoscopy score correlated with the Lewis score (P < .001, ρ = .59) and CECDEIS capsule score (P = .002, ρ = .48). None of the 3 endoscopic scores correlated with PGA, CDAI, HBI, C-reactive protein, erythrocyte sedimentation rate, or fecal calprotectin. Approximately 85% of subjects had proximal small-bowel inflammation identified on CE. There were no CE-related adverse events. CONCLUSIONS: There was high correlation between CE and ileocolonoscopy scores for the assessment of mucosal disease activity over time; however, there were no correlations between endoscopic scores and clinical parameters. The use of serial CE for the assessment of small-bowel CD is feasible and valid. (Clinical trial registration number: NCT01942720.).
BACKGROUND AND AIMS: This prospective, multicenter study evaluated small-bowel capsule endoscopy (CE) for the longitudinal assessment of mucosal inflammation in subjects with Crohn's disease (CD). METHODS: Subjects with known CD underwent clinical evaluation with ileocolonoscopy and CE at baseline and 6-month follow-up. Small-bowel patency was confirmed before CE at both time points. The Simple Endoscopic Score for CD (SES-CD) was used for ileocolonoscopy, and the Lewis score and the CE CD Endoscopic Index of Severity (CECDEIS) were used for CE. Clinical scoring indices included the Physician Global Assessment (PGA), CD Activity Index (CDAI), and Harvey-Bradshaw Index (HBI). Laboratory markers including C-reactive protein, fecal calprotectin, and erythrocyte sedimentation rate were collected at baseline and follow-up. Correlation between endoscopic scores and clinical parameters were measured using Spearman tests. RESULTS: A total of 74 subjects were enrolled, of whom 53 (72%) completed endoscopic procedures at baseline and 6-month follow-up. The SES-CD ileocolonoscopy score correlated with the Lewis score (P < .001, ρ = .59) and CECDEIS capsule score (P = .002, ρ = .48). None of the 3 endoscopic scores correlated with PGA, CDAI, HBI, C-reactive protein, erythrocyte sedimentation rate, or fecal calprotectin. Approximately 85% of subjects had proximal small-bowel inflammation identified on CE. There were no CE-related adverse events. CONCLUSIONS: There was high correlation between CE and ileocolonoscopy scores for the assessment of mucosal disease activity over time; however, there were no correlations between endoscopic scores and clinical parameters. The use of serial CE for the assessment of small-bowel CD is feasible and valid. (Clinical trial registration number: NCT01942720.).