The Efficiency of Colon Capsule Endoscopy in Colon Cancer Screening

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Colon Cancer

Intervention / Treatment
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* Device: Pillcam® COLON 2 Capsule
* Procedure: Colonoscopy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pillcam® COLON 2 Capsule and colonoscopy<br>Persons with positive immunochemical fecal occult blood tests will be examined by second generation colon capsule endoscopy (CCE2) and optical colonoscopy afterwards. | Device: Pillcam® COLON 2 Capsule<br>* 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.<br>Procedure: Colonoscopy<br>* Optical colonoscopy is the standard method for evaluating the colon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative predictive value (NPV) of the CCE2 for large polyps (≥ 10 mm) |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CCE2 accuracy for detection of advanced adenomas |  | 1 day | 
| CCE2 accuracy for detection of colon cancer |  | 1 day | 
| CCE2 and optical colonoscopy acceptance (special questionnaire) |  | 1 day | 
| Cost-effectiveness analyses: cost reduction of preventive colonoscopies spared |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, screening, colon capsule, colonoscopy