COlon Capsule Endoscopy as an AlterNative for CT-colonography in Colorectal Cancer Screening

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

1. Participation in the Dutch national CRC screening programme
2. Positive result on FIT screening
3. Contra-indications to undergo colonoscopy or sedation OR
4. Not willing to undergo colonoscopy OR
5. Prior incomplete colonoscopy

Exclusion Criteria

1. Inability or refusal to provide informed consent
2. Persons with a severe or terminal disease with a life-expectancy of less
than 5 years
3. An allergy or any other known contraindication to the medication used in
this study
4. Renal failure, eGFR <30 ml/min/1.73m2
5. Congestive heart failure NYHA class III or IV
6. Dysphagia or other swallowing disorder which makes it impossible to swallow
the capsule
7. High risk of capsule retention: IBD, personal history of gastrointestinal
surgery other than uncomplicated procedures that would be unlikely to lead to
bowel obstruction based on the clinical judgment of the investigator
8. Cardiac pacemakers or other implanted electro-medical equipment
9. An MRI scheduled within 14 days after ingestion of the capsule
10. Patients with diagnosed or suspected Congenital Long QT Syndrome
11. Patients with high risk concomitant use of drugs that prolong the QT
interval. The risk should be based on the concerning medication in combination
with the dosages and should be evaluated based on the clinical judgement of the
investigator.
12. Patients with manifest hyperthyroidism
13. Patients with an allergy or hypersensitivity for iodinated agents

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the applicability of Colon Capsule Endoscopy in patients screened<br /><br>positive with a fecal immunochemical test (FIT) who have a contra-indication<br /><br>for subsequent colonoscopy, who are unwilling to undergo colonoscopy or who had<br /><br>a prior incomplete colonoscopy within the Dutch colorectal cancer screening<br /><br>setting by:<br /><br>a. Evaluating diagnostic yield of Colon Capsule endoscopy<br /><br>b. Evaluating the participation rate of the Colon Capsule endoscopy<br /><br>c. Evaluating the expected- and perceived burden of Colon Capsule Endoscopy.<br /><br>d. Evaluating the workability for the staff of Colon Capsule Endoscopy.<br /><br>e. Evaluating the interobserver variability between different reviewers of<br /><br>Colon Capsule Endoscopy. </p><br>

Secondary Outcome Measures