N/A
N=45
Capsule Endoscopy in Inflammatory Bowel Disease (IBD) in Children
IBD
Bottom Line
View on ClinicalTrials.gov: NCT02182947 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Diagnostic Yield of Magnetic Resonance Enterography (MRE) — 52 % Percentage of Diagnostic yeild
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Capsule endoscopy (Device)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Children's Mercy Hospital Kansas City
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Yield of Magnetic Resonance Enterography (MRE) |
52 | — |
| PRIMARY Diagnostic Yield of Wireless Capsule Endoscopy (WCE) |
37 | — |
| SECONDARY Sensitivity of Magnetic Resonance Enterography (MRE) |
100 | — |
| SECONDARY Sensitivity of Wireless Capsule Endoscopy (WCE) |
83.3 | — |
| SECONDARY Specificity of Magnetic Resonance Enterography (MRE) |
57.14 | — |
| SECONDARY Specificity of Wireless Capsule Endoscopy |
83.3 | — |
| SECONDARY Accuracy of Magnetic Resonance Enterography (MRE)Accuracy |
70 | — |
| SECONDARY Accuracy of Wireless Capsule Endoscopy (WCE) |
80 | — |
Summary
Most of the studies evaluating the roles of MRE and WCE conducted in pediatric patients have been retrospective with the main goal of making a diagnosis in patients with suspected IBD. The current study is the first prospective study in children with known IBD assessing the roles of MRE and WCE in identifying disease exacerbation. This study will help to identify if capsule endoscopy is superior or complementary to MRE in the evaluation of suspected disease exacerbation in IBD patients.
Eligibility Criteria
Inclusion Criteria
- Patients aged 4 to 17.99 years at time of investigation
- IBD/CD and IBD/IC diagnosed based on standard clinical - histologic criteria
- Patient is scheduled to have MRE as standard of care for evaluation of disease severity/ complication.
- Signed permission/assent/consent
Exclusion Criteria
- IBD diagnosis not established
- Recent intestinal tract surgery / resection involving small bowel
- Use of NSAIDs 4 weeks prior to the Capsule endoscopy study.
- Patients are on prokinetic medication.
- Swallowing disorders, esophageal stricture or patients unable to swallow the capsule.
- Presence of gastrointestinal obstruction or ileus.
- Patient with implanted electro-medical device or pacemakers.
Data sourced from ClinicalTrials.gov (NCT02182947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.