A Treat-to-target Strategy Using Pan-enteric Capsule Endoscopy (PCE) in Paediatric Crohn's Disease (CD).

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Treat-to-target Strategy Using Pan-enterica Capsule Endoscopy (PCE) in Paediatric Crohn's Disease (CD).

Conditions
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Inflammatory Bowel Diseases, Children, Only

Intervention / Treatment
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* Device: Pan-enteric Capsule Endoscopy (PCE)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pan-enteric capsule endoscopy (PCE)<br>Evidence of active disease by PCE prompted a change in therapy at the discretion of the treating clinician and according to current available pediatric guidelines. The definition of medical treatment adjustment after evidence of inflammation was: the introduction of steroids or enteral nutrition, the introduction or optimization of immunosuppressives; the introduction, optimization of biologics; or the introduction of both immunosuppressive agents and biologics. In case of a negative PCE and presence of symptoms, the magnetic resonance enterography (MRE) could help in guiding therapeutic decisions. | Device: Pan-enteric Capsule Endoscopy (PCE)<br>* Second generation of colon capsule endoscopy (Medtronic)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitoring mucosal healing | -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 | 52 weeks | 
| Monitoring deep remission | -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 | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treat to Target | -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 | 52 weeks | 
| Diagnostic Yield | percentage of patients with positive finding at PCE, biomarkers, Magnetic Resonance Enterography (MRE) and Small Intestine contrast ultrasonography (SICUS). | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon capsule endoscopy