N/A
N=98
Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease
Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00487396 ↗Enrolled (actual)
98
Serious AEs
1.3%
Results posted
May 2012
Primary outcome: Primary: Diagnostic Yield in Suspected Crohn's Patients (CE Prior to IC vs. IC and SBFT) — 97.3; 57.3 percentage of yield — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Capsule Endoscopy (Device)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Yield in Suspected Crohn's Patients (CE Prior to IC vs. IC and SBFT) |
97.3; 57.3 | <0.0001 sig |
| SECONDARY Diagnostic Yield (CE vs. SBFT) |
93.0; 25.6 | <0.0001 sig |
| SECONDARY Diagnostic Yield (CE vs. IC) |
49.2; 70.5 | 0.085 |
Summary
The aim of this study is to validate the ability of Capsule Endoscopy (CE) to accurately diagnose small bowel (SB) Crohns disease in patients with symptoms of abdominal pain and diarrhea.
The primary objective of the study is to evaluate whether Capsule Endoscopy prior to colonoscopy will improve diagnosis in patients with suspected Crohns disease when compared to standard diagnostic testing.
Eligibility Criteria
Inclusion Criteria
- Patients ages 10-65 years, inclusive
- Patient suffers from either
- diarrhea for more than 6 weeks and less than 3 years and/or
- abdominal pain for more than 6 weeks and less than 3 years and/or
- extra-luminal manifestations of IBD including: erythema nodosum, pyoderma gangrenosum, arthritis, peri-anal disease, uveitis, aphthous stomatitis
- Patient suffers from at least one of the symptoms / lab abnormalities listed below:
- Positive inflammatory marker (ESR, CRP, thrombocytosis, leukocytosis, fecal lactoferrin, fecal alpha-1 antitrypsin) within 3 months prior to enrollment
- Unexplained anemia (less than normal limits) within 3 months prior to enrollment
- Hypoalbuminemia (<3.5 g/dl) within 3 months of enrollment
- Positive ASCA within 3 months of enrollment
- Abnormal white blood cell scan with in 3 months of enrollment
- Stool negative for O&P (C&S) within 3 months of enrollment
- Recurrent Fevers
- Unexplained weight loss, failure to thrive in children
- Gastro-intestinal bleeding including melena and/or hematochezia and/or FOBT positive.
- Chronic perianal disease (fistula, fissure, peri-rectal abscess)
- Abnormal small bowel SBFT and/or enteroclysis and/or abdominal CT not conclusively diagnostic for IBD
- Patient is indicated for Ileo-Colonoscopy
- Patient or legal guardian agrees to sign consent form
Exclusion criteria
- Indeterminate Colitis where the purpose is only to make a definitive diagnosis and where the inclusion criteria are not otherwise met
- Known intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting.
- Definite long stricture seen on radiological exam.
- Suspected GI stricture, followed by agile™ study that could not prove patency of the GI tract.
- Known history of small bowel Crohn's Disease
- Current treatment for active IBD
- Positive Anti-tTG or anti-endomysial antibody
- Any of the following work-up within 1 year of study entry: Capsule Endoscopy, Colonoscopy and Upper GI/SBFT.
- Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during the 4 weeks preceding enrollment
- Patient is pregnant
Data sourced from ClinicalTrials.gov (NCT00487396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.