Short summary

This is a pragmatic, prospective, randomized multicenter non-inferiority study comparing a new minimally invasive diagnostic algorithm using panenteric capsule endoscopy with the traditional diagnostic work-up in patients with clinically suspected Crohn's disease. The primary endpoint is diagnostic completeness, i.e. the proportion af patients achieving a complete gastrointestinal assessment and unambiguous diagnosis with the first-line examination(s).

Rationale

Pan-enteric capsule endoscopy (CE) is a feasible, safe and patient friendly first-line diagnostic procedure reducing the need for ileocolonoscopy (IC) and additional diagnostic procedures in patients examined for clinically suspected CD. The aim of this study is to determine the feasibility, efficacy and safety of pan-enteric CE as the first-line diagnostic procedure compared to traditional diagnostic work-up with IC plus MR enterography or small bowel CE in patients with clinically suspected CD.

Description of the cohort

Patients referred to medical gastroenterology units in the Region of Southern Denmark and Skåne University Hospital, Malmö on suspicion of inflammatory bowel disease.

Data and biological material

Demographic, socioeconomic and clinical characteristics Diagnosis and disease classification Patient satisfaction after diagnostic procedures Disease activity (Simple Clinical Colitis Activity Index and Harvey-Bradshaw index) Biochemistry including fecal calprotectin Endoscopic procedures Result of histology Imaging procedures Medical treatments Visits at the outpatient clinic, general practitioner or nurse including time for preparation for endoscopic procedures Hospital admissions Surgery Sick leave

Collaborating researchers and departments

Department of Medicine, Vejle Hospital

• Maiken Thyregod Jørgensen

Department of Medical Gastroenterology, Odense University Hospital

• Frederik Drejer Thrane
• Jens Kjeldsen

Endoscopy Unit, Skåne University Hospital Malmö

• Ervin Toth
• Gabriele Wurm Johansson