NCT03161886

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

May 19, 2017

Last Update Submit

January 4, 2018

Conditions

Inflammatory Bowel DiseasesChildren, Only

Keywords

colon capsule endoscopy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Treat to Target

    52 weeks

  • Diagnostic Yield

    52 weeks

Study Arms (1)

Pan-enteric capsule endoscopy (PCE)

EXPERIMENTAL

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)

Interventions

Pan-enteric Capsule Endoscopy (PCE)DEVICE

Second generation of colon capsule endoscopy (Medtronic)

Pan-enteric capsule endoscopy (PCE)

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 26363334RESULT

  • D'Arcangelo G, Russo G, Aloi M, Ruggiero C, Maccioni F, Hassan C, Papoff P, Cohen SA, Oliva S. A Treat-to-Target Strategy Guided by Pan-Enteric Evaluation in Children With Crohn's Disease Improves Outcomes at 2 Years. Inflamm Bowel Dis. 2024 Aug 1;30(8):1303-1308. doi: 10.1093/ibd/izad173.

    PMID: 37603835DERIVED

  • 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.

    PMID: 30326301DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Salvatore Oliva, MD

    Sapienza - University of Rome, Azienda Policlinico Umberto I

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 19, 2017

First Posted

May 22, 2017

Study Start

December 1, 2014

Primary Completion

December 1, 2016

Study Completion

January 10, 2017

Last Updated

January 8, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share