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

Inflammatory Bowel Diseases Clinical Trial

— PCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03161886
• Other study ID #: PCE Monitoring CD
• Status: Completed
• Phase: N/A
• First received: May 19, 2017
• Last updated: January 4, 2018
• Start date: December 1, 2014
• Est. completion date: January 10, 2017

Study information

• Verified date: January 2018
• Source: Azienda Policlinico Umberto I
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 10, 2017
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Children, Only
• Crohn Disease
• Inflammatory Bowel Diseases

Intervention

Device:
• Pan-enteric Capsule Endoscopy (PCE)
Second generation of colon capsule endoscopy (Medtronic)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Policlinico Umberto I

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	52 weeks
Secondary	Diagnostic Yield	percentage of patients with positive finding at PCE, biomarkers, Magnetic Resonance Enterography (MRE) and Small Intestine contrast ultrasonography (SICUS).	52 weeks