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Completed

NCT Number: NCT03161886

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

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pan-enteric Capsule Endoscopy (PCE)

Device

Second generation of colon capsule endoscopy (Medtronic)

Primary outcomes

  1. Monitoring mucosal healing

    Time frame: 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

  2. Monitoring deep remission

    Time frame: 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 outcomes

  1. Treat to Target

    Time frame: 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

  2. Diagnostic Yield

    Time frame: 52 weeks

    percentage of patients with positive finding at PCE, biomarkers, Magnetic Resonance Enterography (MRE) and Small Intestine contrast ultrasonography (SICUS).

Sponsors and collaborators

Lead sponsor

Azienda Policlinico Umberto I

Other

Registry information

Official study title

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

Acronym: PCE

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
May 22, 2017
Registry last updated
Jan 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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