Ignite Creation Date:
2024-07-17 @ 10:44 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475560
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-20
Brief Title:
Camera Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Camera Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DanCap
Brief Summary:
The Department of Surgery at Odense University Hospital OUH carries out approximately 10000 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 optical colonoscopy OC is a hospital-based procedure that can require sedation or analgesics and is often considered uncomfortable intimidating or even painful The diagnostic yield of OC 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 OC However CCE offers no therapeutic capability and individuals with clinically significant findings will still require an OC 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
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 OC However CCE offers no therapeutic capability and individuals with clinically significant findings will still require an OC 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
Detailed Description:
As the sensitivity of OC 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 8000 is very close to the number needed to cause one procedure-related death 10000 Therefore there is an increasing need to filter OC 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 OC 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 CCEs 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 OC 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 patients 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
1 Compare the polyp detection rate PDR and CRC detection rates in both groups
2 Investigate the role of FIT-testing and microbiome analyses in CCE-based diagnostics for predictive purposes
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 OC 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 CCEs 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 OC 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 patients 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
1 Compare the polyp detection rate PDR and CRC detection rates in both groups
2 Investigate the role of FIT-testing and microbiome analyses in CCE-based diagnostics for predictive purposes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None