NCT03134586

Advanced Non-Invasive Diagnostics in Inflammatory Bowel Disease

A Comparative Study of the Diagnostic Validity of Ultrasound, Magnetic Resonance Imaging and Capsule Endoscopy of Both the Small and Large Intestine in Suspected Crohn's Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Non-invasive endoscopic procedures (pillcam colon capsule endoscopy, PCCE) and non-ionizing radiological modalities (MR enterocolonography, MREC and ultrasound, US) - offer a sufficiently high diagnostic validity in patients with suspected CD compared to the traditional invasive approach using ileocolonoscopy with biopsies as first line diagnostic modality

Detailed description

This is a prospective, blinded, multicenter study of the diagnostic validity, inter-observer agreement, image quality and subjective experience of discomfort with PCCE, MREC and US in patients with suspected CD. Ileocolonoscopy serves as the diagnostic gold standard. Patients are recruited from 3 centers in the Region of Southern Denmark managing adult patients with inflammatory bowel diseases. Each patient goes through a standardized work-up including medical history, physical examination, C-reactive protein, fecal calprotectin, ileocolonoscopy, PCCE, MREC and US. All examinations are reviewed and described in a standardized fashion. The radiologists and physicians describing PCCE, MREC, and US are blinded to the findings at ileocolonoscopy and the other imaging modalities.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
OTHER	Diagnostic imaging

Timeline

• Start date: 2016-06-01
• Primary completion: 2020-08-31
• Completion: 2020-10-23
• First posted: 2017-05-01
• Last updated: 2022-11-01

Locations

3 sites across 1 country: Denmark