Trial Outcomes & Findings for Capsule Endoscopy in Inflammatory Bowel Disease (IBD) in Children (NCT NCT02182947)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

1.5 years

Results posted on

2021-03-11

Participant Flow

Participant milestones

Participant milestones
Measure	Overall Study Pediatric patients with indeterminate colitis (IC) or Crohn's disease (CD) who are scheduled to undergo routine small bowel screening or surveillance using Magnetic Resonance Enterography (MRE). Subjects will swallow a patency capsule (PC) to study bowel patency.Those patients, who pass an intact Patency Capsule (PC), usually within 40 hours, will ingest the wireless capsule endoscopy (WCE). The WCE will be performed within 1 week of completion of MRE.Wireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients.
Overall Study STARTED	45
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall Study Pediatric patients with indeterminate colitis (IC) or Crohn's disease (CD) who are scheduled to undergo routine small bowel screening or surveillance using Magnetic Resonance Enterography (MRE). Subjects will swallow a patency capsule (PC) to study bowel patency.Those patients, who pass an intact Patency Capsule (PC), usually within 40 hours, will ingest the wireless capsule endoscopy (WCE). The WCE will be performed within 1 week of completion of MRE.Wireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients.
Overall Study Withdrawal by Subject	7
Overall Study Lost to Follow-up	3
Overall Study Failed screening activities	8

Baseline Characteristics

Capsule Endoscopy in Inflammatory Bowel Disease (IBD) in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=27 Participants Pediatric patients with indeterminate colitis (IC) or Crohn's disease (CD) who are scheduled to undergo routine small bowel screening or surveillance using Magnetic Resonance Enterography (MRE). Subjects will swallow a patency capsule (PC) to study bowel patency.Those patients, who pass an intact Patency Capsule (PC), usually within 40 hours, will ingest the wireless capsule endoscopy (WCE). The WCE will be performed within 1 week of completion of MRE.Wireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients.
Age, Continuous	13.46 years STANDARD_DEVIATION 2.40 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race/Ethnicity, Customized Race Unrecorded	27 Participants n=5 Participants
Region of Enrollment United States	27 Participants n=5 Participants
Body Mass Index BMI percentile of each IBD patients	57 Percentile STANDARD_DEVIATION 32.9 • n=5 Participants
Pediatric Crohns Disease Activity Index PCDAI	10.2 units on a scale STANDARD_DEVIATION 12.5 • n=5 Participants
Duration of disease year	1.7 years STANDARD_DEVIATION 2.32 • n=5 Participants
Percentage of patients with biologics use with or without immune modulators	44.4 Percent of patients n=5 Participants
Percentage of patients with inflammatory phenotype of IBD	93 Percent of patients n=5 Participants
Percentage of patients with stricturing phenotype of IBD	7 Percent of patients n=5 Participants

PRIMARY outcome

Timeframe: 1.5 years

Population: The Diagnostic yield of of MRE were calculated based on how many positive MRE test( with score \>3) divided by total number of MRE studies analyzed.

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).

Outcome measures

Outcome measures
Measure	Overall Study n=27 Participants Pediatric patients with indeterminate colitis (IC) or Crohn's disease (CD) who are scheduled to undergo routine small bowel screening or surveillance using Magnetic Resonance Enterography (MRE). Subjects will swallow a patency capsule (PC) to study bowel patency.Those patients, who pass an intact Patency Capsule (PC), usually within 40 hours, will ingest the wireless capsule endoscopy (WCE). The WCE will be performed within 1 week of completion of MRE.Wireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients.
Diagnostic Yield of Magnetic Resonance Enterography (MRE)	52 % Percentage of Diagnostic yeild

PRIMARY outcome

Timeframe: 1.5 years

Population: The diagnostic yield of WCE were calculated based on how many positive SB capsule study detecting SB changes (as defined by positive WCE test) divided by total number of WCE studies analyzed.

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.

Outcome measures

Outcome measures
Measure	Overall Study n=27 Participants Pediatric patients with indeterminate colitis (IC) or Crohn's disease (CD) who are scheduled to undergo routine small bowel screening or surveillance using Magnetic Resonance Enterography (MRE). Subjects will swallow a patency capsule (PC) to study bowel patency.Those patients, who pass an intact Patency Capsule (PC), usually within 40 hours, will ingest the wireless capsule endoscopy (WCE). The WCE will be performed within 1 week of completion of MRE.Wireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients.
Diagnostic Yield of Wireless Capsule Endoscopy (WCE)	37 % Percentage of Diagnostic yeild

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Overall Study n=27 Participants Pediatric patients with indeterminate colitis (IC) or Crohn's disease (CD) who are scheduled to undergo routine small bowel screening or surveillance using Magnetic Resonance Enterography (MRE). Subjects will swallow a patency capsule (PC) to study bowel patency.Those patients, who pass an intact Patency Capsule (PC), usually within 40 hours, will ingest the wireless capsule endoscopy (WCE). The WCE will be performed within 1 week of completion of MRE.Wireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients.
Sensitivity of Magnetic Resonance Enterography (MRE)	100 Percent sensitivity Interval 54.07 to 100.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Overall Study n=27 Participants Pediatric patients with indeterminate colitis (IC) or Crohn's disease (CD) who are scheduled to undergo routine small bowel screening or surveillance using Magnetic Resonance Enterography (MRE). Subjects will swallow a patency capsule (PC) to study bowel patency.Those patients, who pass an intact Patency Capsule (PC), usually within 40 hours, will ingest the wireless capsule endoscopy (WCE). The WCE will be performed within 1 week of completion of MRE.Wireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients.
Sensitivity of Wireless Capsule Endoscopy (WCE)	83.3 Percent sensitivity Interval 35.88 to 99.58

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Overall Study n=27 Participants Pediatric patients with indeterminate colitis (IC) or Crohn's disease (CD) who are scheduled to undergo routine small bowel screening or surveillance using Magnetic Resonance Enterography (MRE). Subjects will swallow a patency capsule (PC) to study bowel patency.Those patients, who pass an intact Patency Capsule (PC), usually within 40 hours, will ingest the wireless capsule endoscopy (WCE). The WCE will be performed within 1 week of completion of MRE.Wireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients.
Specificity of Magnetic Resonance Enterography (MRE)	57.14 Percent specificity Interval 28.86 to 82.34

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Overall Study n=27 Participants Pediatric patients with indeterminate colitis (IC) or Crohn's disease (CD) who are scheduled to undergo routine small bowel screening or surveillance using Magnetic Resonance Enterography (MRE). Subjects will swallow a patency capsule (PC) to study bowel patency.Those patients, who pass an intact Patency Capsule (PC), usually within 40 hours, will ingest the wireless capsule endoscopy (WCE). The WCE will be performed within 1 week of completion of MRE.Wireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients.
Specificity of Wireless Capsule Endoscopy	83.3 Percent specificity Interval 35.88 to 99.58

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Overall Study n=27 Participants Pediatric patients with indeterminate colitis (IC) or Crohn's disease (CD) who are scheduled to undergo routine small bowel screening or surveillance using Magnetic Resonance Enterography (MRE). Subjects will swallow a patency capsule (PC) to study bowel patency.Those patients, who pass an intact Patency Capsule (PC), usually within 40 hours, will ingest the wireless capsule endoscopy (WCE). The WCE will be performed within 1 week of completion of MRE.Wireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients.
Accuracy of Magnetic Resonance Enterography (MRE)Accuracy	70 Percent accuracy Interval 45.72 to 88.11

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Overall Study n=27 Participants Pediatric patients with indeterminate colitis (IC) or Crohn's disease (CD) who are scheduled to undergo routine small bowel screening or surveillance using Magnetic Resonance Enterography (MRE). Subjects will swallow a patency capsule (PC) to study bowel patency.Those patients, who pass an intact Patency Capsule (PC), usually within 40 hours, will ingest the wireless capsule endoscopy (WCE). The WCE will be performed within 1 week of completion of MRE.Wireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients.
Accuracy of Wireless Capsule Endoscopy (WCE)	80 Percent accuracy Interval 56.34 to 94.27

Adverse Events

Overall Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nadia Hijaz

Children's Mercy Hospital

Phone: 3139204958

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place