The Efficiency of Colon Capsule Endoscopy in Colon Cancer Screening

Military University Hospital, Prague

Status: Unknown

Conditions: Colon Cancer

Treatments: Procedure: Colonoscopy; Device: Pillcam® COLON 2 Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03052335

16-29614A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

230 participants in 1 patient group

Pillcam® COLON 2 Capsule and colonoscopy

Experimental group

Description:

Persons with positive immunochemical fecal occult blood tests will be examined by second generation colon capsule endoscopy (CCE2) and optical colonoscopy afterwards.

Treatment:

Device: Pillcam® COLON 2 Capsule

Procedure: Colonoscopy