Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease

Summary

The goal of this clinical trial is to learn whether a camera pill examination of the whole bowel can be used to diagnose Crohn's disease instead of colonoscopy and a small bowel examination (either MRI or camera pill) in patients aged 18-40 years suspected of having Crohn's disease.

The main question it aims to answer is:

How many patients examined with a camera pill examination of the whole bowel will have a complete examination of the whole bowel and have a diagnosis made without need for any more examinations?

Researchers will compare with patients examined with colonoscopy and a small bowel examination.

Participants will:

* Be examined with either a camera pill examination of the whole bowel, or a colonoscopy and a small bowel examination
* Have their electronic medical records checked to see if a diagnosis has been made
* Have an interview every three months if diagnosed with an inflammatory bowel disease or after a year if no disease was found

Conditions

• Crohn's Disease

Interventions

DIAGNOSTIC_TEST

Panenteric capsule endoscopy

Panenteric capsule endoscopy

DIAGNOSTIC_TEST

Ileocolonoscopy

Endoscopic examination of the colon and terminal ileum after bowel preparation.

DIAGNOSTIC_TEST

MRI enterography

MRI of the small bowel

DIAGNOSTIC_TEST

Small bowel capsule endoscopy

Capsule endoscopy of the small bowel

Sponsors & Collaborators

• Odense University Hospital

  collaborator OTHER

• Svendborg Hospital

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Vejle Hospital

  collaborator OTHER

• Esbjerg Hospital - University Hospital of Southern Denmark

  lead OTHER

Principal Investigators

• Frederik D Thrane, MD · Esbjerg Hospital - University Hospital of Southern Denmark

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-26

Primary Completion

2027-08-31

Completion

2028-08-31

Countries

• Denmark
• Sweden

Study Locations