Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy

Colorectal Cancer Clinical Trial

— SOCRATEC  

Official title:

Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04307901
• Other study ID #: 20/4408
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: May 2020
• Source: Odense University Hospital
• Contact: Gunnar Baatrup, Prof.
• Phone: +4520575154
• Email: gunnar.baatrup[@]rsyd.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Following European guidelines patients undergoing colonoscopy in one of Odense University Hospitals units will now be offered a colon capsule endoscopy (CCE) in case of incomplete examinations. Patients formerly referred to colonoscopy in general anesthesia or patients who decline colonoscopy after having completed bowel preparation will also be offered a CCE. In our department we have conducted a comparison study documenting that the sensitivity of CCE is superior to CT colonography in both polyps >9 mm and polyps >5 mm, which is also supported by an Italian study. The safety and completion rate of CCE following incomplete colonoscopy is confirmed by several studies including one multicenter study and the completion rate is not significantly lower compared to other patient groups. In an incomplete colonoscopy it is always the most oral part of the colon which is not visualized, whereas in CCE, an incomplete investigation will most often have visualized the oral part. By combining incomplete colonoscopy results and incomplete CCE results we can identify patients who have had a complete colon investigation although both investigations were incomplete.

Aim: to investigate the quality of CCE and the completion rate in patients who have undergone an incomplete colonoscopy, have completed bowel preparation but declines colonoscopy or have been referred to colonoscopy in general anesthesia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2030
• Est. primary completion date: October 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Incomplete colonoscopy, referral for colonoscopy under general anesthesia or declining colonoscopy after completion of bowel preparation.

Exclusion Criteria:

• Chrohn's disease with symptoms of stenosis and/or pacemaker

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Colorectal Polyp

Intervention

Device:
• Colon capsule endoscopy
Endoscopy performed using PillCam2 camera capsule for oral ingestion

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Svendborg

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete mucosal visualization combining incomplete investigations	By combining results from incomplete colon capsule endoscopy and incomplete colonoscopy we will identify complete combined investigations.	10 years
Secondary	Completion rate of colon capsule endoscopy	Total and subgroup completion rates of investigations	2 years
Secondary	Safety of colon capsule endoscopy	Total and subgroup safety of investigations	1 year
Secondary	Quality of colon capsule endoscopy	Sensitivity and specificity compared to colonoscopies	1 year
Secondary	Economic evaluation	Economic analyses and evaluations comparing cost of investigations per patient and per case by investigation type.	1 year
Secondary	Patient preference	Investigation of patient preferences stratified by demographic characteristics and history of endoscopic procedures	2 years