Health TrialsbyHealthPanel

Camera Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases

ConditionColorectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital

About this trial

The Department of Surgery at Odense University Hospital (OUH) carries out approximately 10,000 colonoscopies each year, and this number is continuously increasing. Since 2014, the screening for colorectal cancer (CRC) has resulted in a significant increase in the colonoscopy workload. Conventional colonoscopy (CC) is a hospital-based procedure that can require sedation or analgesics and is often considered uncomfortable, intimidating, or even painful. The diagnostic yield of CC can be as low as 3-5% in some patient groups, which means that an endoscopist may need to perform 20 to 30 colonoscopies to identify one case requiring treatment. Physical or cultural barriers can also deter patients from attending appointments, leading to missed cancers or precancerous lesions. To address these challenges, an alternative pathway is needed to reduce the colonoscopy burden on the healthcare system while ensuring fewer findings are missed.

One solution is to use Colon Capsule Endoscopy (CCE) as a triage tool. This procedure can be performed in outpatient healthcare centers and requires less equipment than an CC. However, CCE offers no therapeutic capability, and individuals with clinically significant findings will still require an CC. A low reinvestigation rate (\<25%-30%) is desirable for patient preference and the economy.

Therefore, DanCap will introduce a new pathway that relies on CCE for routine colorectal examinations of symptomatic patients who are expected to have a low rate of positive findings and, consequently, a low reinvestigation rate, and asses the cost of this new pathway.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Older than 18 years

Symptomatic patient referred for colonoscopy assessment

Able to provide oral and written informed consent

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • CCE arm

    Diagnostic test

    Twice a week, patients will attend the in-hospital clinic in groups of four persons. They will bring their completed FIT sample, questionnaire, and the signed consent form. A project nurse will administer the capsules in the morning, and the patients can leave after. When the capsule investigation is completed, patients must return their belt and receiver to the Department of Surgery, OUH. After a few days, the patient will receive an electronic letter with the results and information regarding upcoming steps. Those with positive findings or an incomplete investigation will be given a new appointment according to the current clinical routine. A second questionnaire will be sent to the patient 2 weeks after the completed procedure.

  • CC arm

    Diagnostic test

    Patients will start bowel cleansing according to the instructions. They will bring their completed questionnaire and the signed consent form to the scheduled colonoscopy. They will continue to follow the routine clinical setup for outpatient colonoscopy and will only receive, by digital post, after 2 weeks from the procedure, an extra second questionnaire.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: CCE armActive comparator 1 intervention
Group B: CC armPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cost consequence analysis

The cost-consequence analysis will draw on data from a variety of sources, including the National Technology Council and their cost outline, administrative data from the Department of Surgery, daily observations by the research team, timeline inputs from the clinical software 'Bookplan', patient and societal resource use from questionnaires, and other relevant information extracted from patients' electronic health records. The average cost per patient for each study arm will be estimated by integrating cost data from The Treatment Council and Department of Surgery with recorded resource use, into a consolidated estimate.

Time frame
1 year

Secondary outcomes

1

Reinvestigation rate of CCE

Due to unacceptable technical quality, incomplete examination or positive CCE findings.

Time frame
1 year
2

Comparative analysis of detection rates for CCE and CC

Polyp detection rate in both pathways, categorized as "\<6 mm", "6-9 mm" and "\>9 mm"

Time frame
1 year
3

Predictive value of FIT

Correlation between the detected concentration of haemoglobin in the FIT sample (μg Hb/g of faeces) and positive findings

Time frame
1 year
4

Gut microbiome

Corelation between the composition of the microbiome (certain types of bacterias from the stool sample-FIT) and positive findings at CCE or CC

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Odense University Hospital

Lead sponsor

Region Syddanmark

Collaborator

Source ClinicalTrials.gov
Apply now