Colon Capsule Endoscopy as an Alternative to CT-colonography in Colorectal Cancer Screening

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25818

Enrollment

100

Registered

2020-07-02

Start date

2020-07-02

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study focuses on colorectal cancer screening (including the diagnostic yield for polyps and colorectal cancer).

Interventions

Colon Capsule Endoscopy

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following 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

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 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 concomitant use of drugs that prolong the QT interval 12. Patients with insulin dependent diabetes 13. Patients with manifest hyperthyroidism 14. Patients with an allergy or hypersensitivity for iodinated agents

Design outcomes

Primary

Measure	Time frame
To evaluate the applicability of CCE in colorectal cancer screening in terms of: diagnostic yield, participation rate, patients’ expected and perceived burden of CCE, the workability of CCE for the staff and the interobserver variability in reviewing the CCE images. Interested patients who meet all inclusion- and exclusion criteria will get an appointment to undergo Colon Capsule Endoscopy. Patients expected and perceived burden of CCE will be measured by 2 questionnaires, one prior to the procedure and one afterwards. The workability for the staff will be measured by a questionnaire which will be handed out to all staff working with CCE within this trial.	—

Measure

Time frame

To evaluate the applicability of CCE in colorectal cancer screening in terms of: diagnostic yield, participation rate, patients’ expected and perceived burden of CCE, the workability of CCE for the staff and the interobserver variability in reviewing the CCE images. Interested patients who meet all inclusion- and exclusion criteria will get an appointment to undergo Colon Capsule Endoscopy. Patients expected and perceived burden of CCE will be measured by 2 questionnaires, one prior to the procedure and one afterwards. The workability for the staff will be measured by a questionnaire which will be handed out to all staff working with CCE within this trial.

—

Secondary

Measure	Time frame
Only primary outcomes, see above.	—

Contacts

Public ContactManon Spaander

Erasmus Medical Center

v.spaander@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)