Comparison of Bowel Ultrasound & MR Enterography in the Follow-up of Previously Diagnosed Pediatric Small Bowel Crohn Disease

Not Applicable

Terminated

• Conditions: Crohn Disease
• Interventions: Procedure: Bowel ultrasound; Procedure: magnetic resonance enterography (MRE)

• Registration Number: NCT01671579
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

To establish the accuracy of bowel ultrasound in the follow-up of known (previously diagnosed) pediatric small bowel Crohn disease, using MR Enterography (magnetic resonance imaging technology used to obtain detailed images of the small bowel) as the reference standard.

Detailed Description

25-30% of individuals with Crohn disease present during childhood or adolescence, and the incidence is rising. MRE (magnetic resonance enterography) is considered the standard of care for imaging of pediatric small bowel Crohn's disease. Bowel ultrasound is an emerging technology for bowel assessment and offers several advantages over MRE, including lower cost, shorter exam time, and lack of need for sedation and contrast materials and bowel medication. The researchers goal is to assess the accuracy of bowel ultrasound in the follow-up of known pediatric small bowel Crohn disease using MRE and the reference standard.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-08-20
• Study First Submitted QC: 2012-08-22
• Study First Posted: 2012-08-23
• Primary Completion: 2017-07
• Study Completion: 2017-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• 18 years of age or younger
• Subjects with known small bowel Crohn disease undergoing a clinically ordered imaging follow-up with MR enterography.

Exclusion Criteria

• Subjects with suspected or newly diagnosed Crohn disease

• Subject who have the following in their body may not undergo MRE imaging:

  • Metal chips/shrapnel
  • Surgical clips
  • Artificial joints
  • Metallic bone plates
  • Prosthetic devices
  • Heart pacemakers
  • Clips in or around the eye balls
  • artificial heart valves
  • Bullet fragments
  • Chemotherapy or insulin pumps

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pediatric small bowel Crohn disease	Bowel ultrasound	Subjects with previously diagnosed PSBCD (pediatric small bowel Crohn disease)who are scheduled for a clinically MRE (magnetic resonance enterography)imaging exam.
Pediatric small bowel Crohn disease	magnetic resonance enterography (MRE)	Subjects with previously diagnosed PSBCD (pediatric small bowel Crohn disease)who are scheduled for a clinically MRE (magnetic resonance enterography)imaging exam.

Primary Outcome Measures

Name	Time	Method
Follow-up of known small bowel Crohn disease	1 year	A variety of imaging findings will be documented by ultrasound and correlated with the imaging findings from the clinically ordered MRE exam to determine the efficacy of bowel ultrasound in the follow-up of small bowel Crohn disease in pediatric subjects.

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States