Capsule Endoscopy in Inflammatory Bowel Disease (IBD) in Children
Condition: IBD
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Capsule endoscopy
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): Wireless capsule endoscopy, Pillcam from given imaging
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Pediatric; Inflammatory Bowel Disease; Wireless capsule endoscopy; MRE; Crohn's Disease; Indeterminant Colitis; Small bowel Crohn's Disease