Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Capsule Endoscopy in Inflammatory Bowel Disease (IBD) in Children (CE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02182947
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : May 20, 2019
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Nadia Hijaz, Children's Mercy Hospital Kansas City

Tracking Information
First Submitted Date  ICMJE June 30, 2014
First Posted Date  ICMJE July 8, 2014
Last Update Posted Date May 20, 2019
Actual Study Start Date  ICMJE August 2012
Actual Primary Completion Date December 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
Primary aim [ Time Frame: 1.5 years ]
Compare the diagnostic yield of Magnetic Resonance Enterography (MRE) with Small-Bowel Capsule Endoscopy (SBCE) in pediatric patients with known Inflammatory Bowel Disease (IBD) including Crohn's disease (CD) or indeterminate colitis (IC).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
  • Detection rate [ Time Frame: 2 years ]
    To determine the detection rate of small bowel disease / 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Capsule Endoscopy in Inflammatory Bowel Disease (IBD) in Children
Official Title  ICMJE Comparison of the Use of Wireless Capsule Endoscopy With Magnetic Resonance Enterography in Children With Inflammatory Bowel Disease
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE IBD
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Endoscopy Imaging
Wireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients.
Intervention: Device: Capsule endoscopy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2019)
45
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2014)
34
Actual Study Completion Date  ICMJE December 30, 2018
Actual Primary Completion Date December 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02182947
Other Study ID Numbers  ICMJE 13080263
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nadia Hijaz, Children's Mercy Hospital Kansas City
Study Sponsor  ICMJE Children's Mercy Hospital Kansas City
Collaborators  ICMJE Medtronic - MITG
Investigators  ICMJE
Principal Investigator: Nadia M Hijaz, MD Children's Mercy
PRS Account Children's Mercy Hospital Kansas City
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP