Camera Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases

As the sensitivity of CC and CCE is constantly increasing and progressively smaller-size pathologies are detected, the association between detected lesions and patients short- and long-term outcomes is becoming more uncertain. In some cases, such as with the resection of diminutive polyps, the number needed to treat to save one person (approx. 8.000) is very close to the number needed to cause one procedure-related death (10.000). Therefore, there is an increasing need to filter CC candidates and define a realistic threshold for treating or ignoring lesions.

The DanCap study fulfils this need by introducing a renewed approach to the diagnostic pathways using CCE. This approach offers out-of-hospital, accurate bowel diagnostics that allow for the decongestion of endoscopic services, as seen in the UK. It has an upscaling potential for national and international redesign of bowel diagnostics. Several clinical trials have demonstrated the strengths and weaknesses of CCE as compared to CC. The Scottish and English Services have shown the feasibility of routine use of CCE and the CCE-based services confirmed already known data with real-world equivalents regarding CCE's safety and high diagnostic quality. However, there are remaining concerns, primarily due to the high (45-60%) re-investigation rate, which makes the patient experience and cost-efficiency of CCE-based services inferior to that of the conventional CC counterpart. Based on these recent findings, setting up a routine diagnostic pathway for further evaluation of CCE in the clinical routine of patients with a low frequency of positive findings, including cost-efficiency assessment, is highly relevant. Here, introducing methods to predict a patient's findings may be extra relevant in the future. Currently, studies suggest that the use of faecal haemoglobin concentration or the microbiome composition may be useful biomarkers for colorectal cancer or precursor lesions. The predictive potential of these biomarkers in a diagnostic pathway has yet to be sufficiently tested, and more evidence is needed before clinical application is possible.

Our study aims to investigate the DanCap pathway as a viable solution for CCE-based diagnostics in symptomatic patients, considered to have a high need for endoscopic evaluation due to the symptoms compatible with neoplastic disease, as referred from general practice (GP). This approach is expected to be cost-effective and maintain high clinical quality while relieving the burden on endoscopy wards in a Danish setting.

The study will provide data for pathway cost analysis of the CCE-based pathway compared to the traditional colonoscopy pathway based on a realistic medicine outcomes assessment.

The secondary aims are to:

• Compare the polyp detection rate (PDR) and CRC detection rates in both groups
• Investigate the role of FIT-testing and microbiome analyses in CCE-based diagnostics for predictive purposes

Inclusion criteria

• Older than 18 years
• Symptomatic patient referred for colonoscopy assessment
• Able to provide oral and written informed consent

Exclusion criteria

• Require hospital admission for inpatient colonoscopy
• Previous OC with poor bowel preparation within the last 5 years
• Patient is unable to provide oral and written informed consent
• History of stenosis of the digestive tract
• Previous major surgery of the digestive tract with consequence of an internal derivation or a stoma*
• Patient has a pacemaker/defibrillator
• Patient is pregnant or breastfeeding
• Known allergies to the bowel preparation regimen
• Have severe kidney disease
• Known chronic constipation
• Imaging examination suggestive for a colorectal tumour
• Anamnestic suspicion of microscopic colitis, where biopsy is needed *including Whipple