Capsule Endoscopy in Inflammatory Bowel Disease (IBD) in Children (CE)
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|ClinicalTrials.gov Identifier: NCT02182947|
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : May 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|IBD||Device: Capsule endoscopy||Not Applicable|
Proximal small bowel (SB) involvement in CD is associated with a more aggressive disease course and an increased need for surgery.Therefore, accurate determination of SB involvement in pediatric CD is crucial for optimal patient management. Current clinical guidelines include suggested modalities to identify SB involvement and determine management plans. Available options include small bowel series, computed tomography enterography (CTE), small bowel wireless capsule endoscopy (WCE), gadolinium enhanced MRI imaging (GAD MRI), and small bowel contrast enhanced ultrasound (US). The choice of modality is largely determined by available resources, radiation exposure risk, and physician and institutional preferences. MRE and contrast enhanced US are radiation free, while other radiologic modalities entail a risk of radiation exposure. WCE may entail a risk of capsule retention. The risk of capsule retention resulting in obstruction is increased in the context of stricturing or fistulizing disease in CD and has been estimated at 2.6% but may be greatly mitigated by patency capsule screening.
Magnetic resonance enterography (MRE) and small bowel contrast ultrasound (SICUS) have diagnostic effectiveness comparable to other radiological modalities for evaluation of CD patients. However, both studies have their own limitations, MRE is limited by expense, the availability of the requisite equipment and software, variable expertise in interpretation of the findings, and (potentially) the need for sedation in pediatric population. SICUS is similarly affected by being operator dependent with the requisite need of accumulated expertise and heightened need for cooperation during the study that can limit its use in pediatric populations.
Several diagnostic modalities have been evaluated in comparison to WCE in several pediatric and adult IBD studies. The studies conducted in children with IBD were mostly retrospective and aimed at evaluating the role of MRE and WCE for detection of SB disease. They concluded that MRE and WCE were comparable with similar sensitivities. Only three prospective studies (all European) in pediatric IBD have compared WCE and MRE modalities in identifying SB disease involvement. Two were studies in established CD and one in suspected CD and again, they suggested that the tests appear complementary for detection of active CD. The current study is the a another prospective study in children with established IBD in the United States assessing the roles of MRE and WCE in identifying SB disease involvement in IBD. This study provides evidence for capsule endoscopy in the evaluation of established disease exacerbation in patients with IBD in relation to MRE.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of the Use of Wireless Capsule Endoscopy With Magnetic Resonance Enterography in Children With Inflammatory Bowel Disease|
|Actual Study Start Date :||August 2012|
|Actual Primary Completion Date :||December 30, 2018|
|Actual Study Completion Date :||December 30, 2018|
Experimental: Endoscopy Imaging
Wireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients.
Device: Capsule endoscopy
Pediatric patients with indeterminate colitis (IC) or Crohn's disease (CD) who are scheduled to undergo routine small bowel screening or surveillance using MRE. Subjects will swallow a patency capsule (PC) to study bowel patency.Those patients, who pass an intact PC, usually within 40 hours, will ingest the wireless capsule endoscopy (WCE). The WCE will be performed within 1 week of completion of MRE.
Other Name: Wireless capsule endoscopy, Pillcam from given imaging
- Primary aim [ Time Frame: 1.5 years ]Compare the diagnostic yield of Magnetic Resonance Enterography (MRE) with Wireless Capsule Endoscopy (WCE) in pediatric patients with known Inflammatory Bowel Disease (IBD) including Crohn's disease (CD) or indeterminate colitis (IC).
- Detection rate [ Time Frame: 2 years ]To determine the concondrance rate of small bowel disease in between MRE and WCE / complications, subjected to a strategy of Wireless Capsule Endoscopy (WCE) - small bowel screening / surveillance vs MRE in a pediatric tertiary medical institution.
- Sensitivity and specificity [ Time Frame: 2 years ]Compare sensitivity and specificity of both MRE and WCE in identifying patients with active vs. inactive CD and IC as defined by the Pediatric Crohn's disease activity index and in reference to the small bowel histological tissue that is available to subgroup of patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02182947
|United States, Kansas|
|Children Mercy Hospital and Clinics|
|Kansas City, Kansas, United States, 66223|
|Principal Investigator:||Nadia M Hijaz, MD||Children's Mercy|