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

Azienda Policlinico Umberto I

Status: Completed

Conditions: Children, Only; Inflammatory Bowel Diseases

Treatments: Device: Pan-enteric Capsule Endoscopy (PCE)

Study type: Interventional

Funder types: Other

Identifiers

NCT03161886

PCE Monitoring CD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Pan-enteric capsule endoscopy (PCE)

Experimental group

Description:

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.

Treatment:

Device: Pan-enteric Capsule Endoscopy (PCE)