The Efficiency of Colon Capsule Endoscopy in Colon Cancer Screening

Colon Cancer Clinical Trial

Official title:

The Comparison of the Efficiency of Colon Capsule Endoscopy and Optical Colonoscopy in Patients With Positive Immunochemical Fecal Occult Blood Test

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03052335
• Other study ID #: 16-29614A
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2019
• Source: Military University Hospital, Prague
• Contact: Stepan Suchanek, MD., Ph.D.
• Phone: 973208367
• Email: stepan.suchanek[@]uvn.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Main objective is to improve colorectal cancer (CRC) screening programme in the Czech Republic and decrease the disease incidence and mortality. The secondary aim is to verify the effectiveness of incorporation of the new minimally invasive device in the prevention programme.

Description:

Multicentre, multidisciplinary (3 gastroenterology units; biostatistics department; cooperation with general practitioners), prospective study is focused on examination of individuals with average colorectal cancer (CRC) risk (asymptomatic, age 50-75 years).

In years 2017 - 2019, there will be 230 persons with positive semi-quantitative immunochemical fecal occult blood tests (FIT; QuikRead, Orion Diagnostica Oy, Finland) with cut-off level 75 ng/ml involved. Every person will be examined by second generation colon capsule endoscopy (CCE2) and optical colonoscopy afterwards.

Main objective is to show that the negative predictive value (NPV) of the CCE2 applied in patients with positive FIT results is sufficient to include this method in the National CRC screening as filter test with aim to reduce the necessity of subsequent optical colonoscopy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• age 50 - 75 years

• asymptomatic (no enterorhagy, weight loss or anemia)

• signed informed consent with the study and with colonoscopy

Exclusion Criteria:

• CRC high-risk group patients

• having first degree relatives diagnosed with colorectal cancer at age ? 60 years

• FAP, HNPCC and other hereditary CRC syndromes probands

• positive personal medical history of colorectal neoplasia (advanced adenomatous polyp, colorectal cancer)

• recent diagnostic, follow-up or preventive colonoscopy in = 3 years (FOBT-positive colonoscopy, screening colonoscopy)

• colonoscopy contraindication

• severe acute inflammatory bowel disease

• severe comorbidities; likely non-compliance of the patient

• no informed consent signed (with the study and/or with colonoscopy)

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Device:
• Pillcam® COLON 2 Capsule
The second generation of PillCam colon capsule endoscopy (CCE-2) is 11.6 mm × 31.5 mm in size and has two imagers, that each have a 172° angle of view, allowing for almost 360° visual coverage of the colon. CCE-2 has an adaptive frame rate from 4 to 35 images per second. This means that the camera is able to capture up to 35 pictures while in motion whereas 4 images per second are captured when it is virtually stationary. During the examination the patient wears a sensor array which is attached to the abdomen and a data recorder for storage of the information generated by the ingested capsule. After the examination the data are downloaded into the workstation and a video is generated.

Procedure:
• Colonoscopy
Optical colonoscopy is the standard method for evaluating the colon

Locations

Country	Name	City	State
Czechia	Military University Hospital	Prague

Sponsors (4)

Lead Sponsor	Collaborator
Military University Hospital, Prague	Institute for Clinical and Experimental Medicine, Masaryk University, University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative predictive value (NPV) of the CCE2 for large polyps (= 10 mm)		1 day
Secondary	CCE2 accuracy for detection of advanced adenomas		1 day
Secondary	CCE2 accuracy for detection of colon cancer		1 day
Secondary	CCE2 and optical colonoscopy acceptance (special questionnaire)		1 day
Secondary	Cost-effectiveness analyses: cost reduction of preventive colonoscopies spared		1 day