This prospective pilot study of 40 pediatric patients with Crohn's Disease, that are candidates for endoscopic and imaging re-evaluation, examines the Given Diagnostic System and the second generation of colon capsule in comparison second generation of colon capsule endoscopy (CCE-2) to magnetic resonance enterography (MRE), small intestine contrast ultrasonography (SICUS) and endoscopy (upper and lower). This study aims 1. To evaluate and compare the accuracy of CCE-2 with MRE, SICUS and endoscopy in the evaluation of pediatric Crohn's disease. 2. To evaluate the safety of CCE-2 in pediatric CD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
40
Pediatric Gastroenterology and Liver Unit, Sapienza - University of Rome
Rome, Rome, Italy
To evaluate and compare the accuracy of Second generation of Colon Capsule Endoscopy with magnetic resonance enterography, small intestine contrast ultrasonography and endoscopy in the evaluation of pediatric Crohn's disease.
Accuracy parameters (sensitivity, specificity, NPV, PPV) of second generation of colon capsule endoscopy compared to endoscopy, to magnetic resonance enterography and to small intestine contrast ultrasonography in evaluating disease activity in pediatric CD. The disease activity will be evaluated with a validated score (SES-CD) for endoscopy and imaging tool (damage-score).
Time frame: 3 days
To evaluate the safety of second generation of colon capsule endoscopy in pediatric Crohn's disease.
Number, type and severity of adverse events with second generation of Crohn's disease.
Time frame: two days
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