Capsule Endoscopy in Inflammatory Bowel Disease (IBD) in Children

Not Applicable

Completed

Conditions: IBD

Interventions: Device: Capsule endoscopy

Registration Number: NCT02182947

Lead Sponsor: Children's Mercy Hospital Kansas City

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 45

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopy Imaging	Capsule endoscopy	Wireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients.

Primary Outcome Measures

Name	Time	Method
Diagnostic Yield of Wireless Capsule Endoscopy (WCE)	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.
Diagnostic Yield of Magnetic Resonance Enterography (MRE)	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).

Secondary Outcome Measures

Name	Time	Method
Accuracy of Wireless Capsule Endoscopy (WCE)	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.
Sensitivity of Wireless Capsule Endoscopy (WCE)	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)	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
Sensitivity of Magnetic Resonance Enterography (MRE)	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).
Specificity of Wireless Capsule Endoscopy	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	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.