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

Not Applicable

Completed

• Conditions: Children, Only; Inflammatory Bowel Diseases
• Interventions: Device: Pan-enteric Capsule Endoscopy (PCE)

• Registration Number: NCT03161886
• Lead Sponsor: Azienda Policlinico Umberto I

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.

Study Timeline

• Study Start: 2014-12-01
• Primary Completion: 2016-12-01
• Study Completion: 2017-01-10
• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-05-19
• Study First Posted: 2017-05-22
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-04
• Last Update Posted: 2018-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pan-enteric capsule endoscopy (PCE)	Pan-enteric Capsule Endoscopy (PCE)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).