Children, Only, Inflammatory Bowel Diseases
Conditions
Keywords
colon capsule endoscopy
Brief summary
This prospective, interventional study aims this to determine the efficacy and safety of a PCE-based treat-to-target strategy in order to achieve Mucosal Healing (MH) and deep remission (DR) of pediatric Crohn's Disease (CD) over 52 weeks.
Detailed description
This first prospective study on mucosal healing (MH) and deep remission (DR) in pediatric Crohn's Disease aims to evaluate: * The ability of Pan-enteric capsule endoscopy (PCE) to assess MH and DR rates at three time points and to guide a treat-to-target strategy was the primary outcome sought. * The efficacy of a treat-to-target strategy to MH and DR rates over 24 and 52 weeks was evaluated as a secondary outcome; * Comparison between PCE, biomarkers, Magnetic Resonance Enterography (MRE) and Small Intestine contrast ultrasonography (SICUS) in evaluating intestinal inflammation.
Interventions
DEVICEPan-enteric Capsule Endoscopy (PCE)
Second generation of colon capsule endoscopy (Medtronic)
Sponsors
Azienda Policlinico Umberto I
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of Crohn's Disease made at least 3 months before the enrolment; * subject was referred for endoscopic and imaging follow-up in Crohn's Disease * signed informed consent.
Exclusion criteria
* Subject has dysphagia * Subject has renal insufficiency * Subject is known structuring Crohn's Disease identified by magnetic resonance enterography (MRE) or small intestine contrast ultrasonography (SICUS). * Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the magnetic resonance enterography findings and clinical judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monitoring mucosal healing | 52 weeks | -The ability of PCE to assess mucosal healing rate (percentage of patients with healing of the mucosa) at three time points and to guide a treat-to-target strategy was the primary outcome sought. and colonic CD |
| Monitoring deep remission | 52 weeks | -The ability of PCE to assess deep remission rate (percentage of patients with healing of the mucosa and absence of symptoms) at three time points and to guide a treat-to-target strategy was the primary outcome sought. and colonic CD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treat to Target | 52 weeks | -The efficacy of a treat-to-target strategy to increase percentage of patients with mucosal healing (healing of the mucosa) and deep remission (healing of the mucosa and absence of symptoms) rates over 24 and 52 weeks |
| Diagnostic Yield | 52 weeks | percentage of patients with positive finding at PCE, biomarkers, Magnetic Resonance Enterography (MRE) and Small Intestine contrast ultrasonography (SICUS). |
Outcome results
None listed