Panenteric capsule endoscopy
Diagnostic TestPanenteric capsule endoscopy
NCT Number: NCT06882993
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
Interested in participating?
Request Info18 year–40 year
All sexes
Interventional
Not applicable
Esbjerg Hospital - University Hospital of Southern Denmark, Esbjerg, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
*A clinical suspicion of CD is based on the following definition:
Exclusion criteria
Panenteric capsule endoscopy
Endoscopic examination of the colon and terminal ileum after bowel preparation.
MRI of the small bowel
Capsule endoscopy of the small bowel
Time frame: Immediately after initial diagnostic procedure
Proportion of patients in each arm achieving a complete gastrointestinal assessment and an unambiguous diagnosis after completion of the initial diagnostic procedure(s) without need for supplementary examinations
Time frame: After completion of follow-up (12 months)
Number of patients with suspected CD examined with pan-enteric CE and the number of ICs avoided
Time frame: After completion of follow-up (12 months)
Need for additional examinations in the two randomization arms
Time frame: After completion of follow-up (12 months)
Number of severe adverse events
Time frame: After completion of follow-up (12 months)
Time from referral or first diagnostic procedure to final diagnosis and treatment
Time frame: After completion of follow-up (12 months)
Disease classification and medical treatments in the two randomization arms
Time frame: Immediately after initial diagnostic procedure
Difference in Gastrointestinal Endoscopy Satisfaction Questionnaire (GESQ) score
Time frame: After completion of follow-up (12 months)
Expenditure on diagnostic procedures, treatment and loss of productivity
Time frame: Immediately after initial diagnostic procedure
Diagnostic utility of AI algorithms in detection of gastrointestinal pathology using pan-enteric CE - sensitivity, specificity, severity, prediction and impact on clinical decision making
Contact information is provided by the study sponsor or research team.
Frederik D Thrane, MD
CONTACT
Michael D Jensen, MD, PhD
CONTACT
Esbjerg Hospital - University Hospital of Southern Denmark
Other
Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease - a Prospective Comparison of Pan-Enteric Capsule Endoscopy Versus Ileocolonoscopy Plus MR Enterography or Small-Bowel Capsule Endoscopy
Acronym: ANDI-3
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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