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

Primary Purpose

Inflammatory Bowel Diseases, Children, Only

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pan-enteric Capsule Endoscopy (PCE)
Sponsored by
Azienda Policlinico Umberto I
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Inflammatory Bowel Diseases focused on measuring colon capsule endoscopy

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Pan-enteric capsule endoscopy (PCE)

    Arm 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.

    Outcomes

    Primary Outcome Measures

    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
    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    May 19, 2017
    Last Updated
    January 4, 2018
    Sponsor
    Azienda Policlinico Umberto I
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03161886
    Brief Title
    A Treat-to-target Strategy Using Pan-enteric Capsule Endoscopy (PCE) in Paediatric Crohn's Disease (CD).
    Acronym
    PCE
    Official Title
    A Treat-to-target Strategy Using Pan-enterica Capsule Endoscopy (PCE) in Paediatric Crohn's Disease (CD).
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2014 (Actual)
    Primary Completion Date
    December 1, 2016 (Actual)
    Study Completion Date
    January 10, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Azienda Policlinico Umberto I

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammatory Bowel Diseases, Children, Only
    Keywords
    colon capsule endoscopy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pan-enteric capsule endoscopy (PCE)
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Device
    Intervention Name(s)
    Pan-enteric Capsule Endoscopy (PCE)
    Intervention Description
    Second generation of colon capsule endoscopy (Medtronic)
    Primary Outcome Measure Information:
    Title
    Monitoring mucosal healing
    Description
    -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
    Time Frame
    52 weeks
    Title
    Monitoring deep remission
    Description
    -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
    Time Frame
    52 weeks
    Secondary Outcome Measure Information:
    Title
    Treat to Target
    Description
    -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
    Time Frame
    52 weeks
    Title
    Diagnostic Yield
    Description
    percentage of patients with positive finding at PCE, biomarkers, Magnetic Resonance Enterography (MRE) and Small Intestine contrast ultrasonography (SICUS).
    Time Frame
    52 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Salvatore Oliva, MD
    Organizational Affiliation
    Sapienza - University of Rome, Azienda Policlinico Umberto I
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26363334
    Citation
    Oliva S, Cucchiara S, Civitelli F, Casciani E, Di Nardo G, Hassan C, Papoff P, Cohen SA. Colon capsule endoscopy compared with other modalities in the evaluation of pediatric Crohn's disease of the small bowel and colon. Gastrointest Endosc. 2016 May;83(5):975-83. doi: 10.1016/j.gie.2015.08.070. Epub 2015 Sep 9.
    Results Reference
    result
    PubMed Identifier
    30326301
    Citation
    Oliva S, Aloi M, Viola F, Mallardo S, Civitelli F, Maccioni F, Hassan C, Papoff P, Cucchiara S, Cohen SA. A Treat to Target Strategy Using Panenteric Capsule Endoscopy in Pediatric Patients With Crohn's Disease. Clin Gastroenterol Hepatol. 2019 Sep;17(10):2060-2067.e1. doi: 10.1016/j.cgh.2018.10.015. Epub 2018 Oct 13.
    Results Reference
    derived

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

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