Capsule Endoscopy in Inflammatory Bowel Disease (IBD) in Children

Overview

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.

Full Title of Study: “Comparison of the Use of Wireless Capsule Endoscopy With Magnetic Resonance Enterography in Children With Inflammatory Bowel Disease”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Diagnostic
  • Masking: None (Open Label)
• Study Primary Completion Date: December 30, 2018

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.

Interventions

• 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.

Arms, Groups and Cohorts

• Experimental: Endoscopy Imaging
  • Wireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients.

Clinical Trial Outcome Measures

Primary Measures

• Diagnostic Yield of Magnetic Resonance Enterography (MRE)
  • Time Frame: 1.5 years
  • The reported positive Magnetic Resonance Enterography (MRE) studies percentage in pediatric patients with known Inflammatory Bowel Disease (IBD) including Crohn’s disease (CD) or indeterminate colitis (IC). Diagnostic yield DY of MRE that is the ability of a test to show positive findings to diagnose small bowel Crohns disease based on specified criteria used in the study.The study is positive if it has score of >3 of radiological findings of (SB wall thickness, SB wall enhancement , mucosal and serosal enhancement suggestive of mesenteric fatty infiltration, strictures, comb sign which is increased mesenteric vascularity adjacent to the inflamed bowel loop, reactive mesenteric lymphadenopathy, the presence of fistula, stricture or abscess and the number of SB segments involved).
• Diagnostic Yield of Wireless Capsule Endoscopy (WCE)
  • Time Frame: 1.5 years
  • The reported positive Wireless Capsule Endoscopy (WCE) percentage in pediatric patients with known Inflammatory Bowel Disease (IBD) including Crohn’s disease (CD) or indeterminate colitis (IC). Diagnostic yield of wireless capsule endoscopy is the ability of this test to detect abnormalities and diagnose positive small bowel crohns disease. The positive (or active) WCE is defined if clear abnormalities of the SB mucosa (ulcerations >3, erosions, polyps, vascular lesions, and bleeding lesions). White lesions within a crater with surrounding erythema were considered ulcers, whereas small superficial white lesions, even with surrounding erythema, were considered erosions.

Secondary Measures

• Sensitivity of Magnetic Resonance Enterography (MRE)
  • Time Frame: 1.5 years
  • The sensitivity MRE in identifying patients with active vs. inactive CD and IC as defined by the Pediatric Crohn’s disease activity index (PCDAI).
• Sensitivity of Wireless Capsule Endoscopy (WCE)
  • Time Frame: 1.5 years
  • The sensitivity of WCE in identifying patients with active vs. inactive CD and IC as defined by the Pediatric Crohn’s disease activity index (PCDAI)
• Specificity of Magnetic Resonance Enterography (MRE)
  • Time Frame: 1.5 years
  • The specificity of MRE in identifying patients with active vs. inactive CD and IC as defined by the Pediatric Crohn’s disease activity index PCDAI
• Specificity of Wireless Capsule Endoscopy
  • Time Frame: 1.5 years
  • The specificity of WCE in identifying patients with active vs. inactive CD and IC as defined by the Pediatric Crohn’s disease activity index PCDAI
• Accuracy of Magnetic Resonance Enterography (MRE)Accuracy
  • Time Frame: 1.5 years
  • The accuracy of Magnetic Resonance Enterography (MRE) in pediatric patients with known Inflammatory Bowel Disease (IBD) including Crohn’s disease (CD) or indeterminate colitis (IC) in reference to pediatric Crohn’s disease activity index PCDAI.
• Accuracy of Wireless Capsule Endoscopy (WCE)
  • Time Frame: 1.5 years
  • The accuracy of WCE in pediatric patients with known Inflammatory Bowel Disease (IBD) including Crohn’s disease (CD) or indeterminate colitis (IC) in reference to pediatric Crohn’s disease activity index PCDAI.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 4 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Children’s Mercy Hospital Kansas City
• Collaborator
  • Medtronic – MITG
• Provider of Information About this Clinical Study
  • Principal Investigator: Nadia Hijaz, MD – Children’s Mercy Hospital Kansas City
• Overall Official(s)
  • Nadia M Hijaz, MD, Principal Investigator, Children’s Mercy

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