The Efficiency of Colon Capsule Endoscopy in Colon Cancer Screening

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

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.

Study Overview

• Status: Unknown
• Conditions: Colon Cancer
• Intervention / Treatment: Device: Pillcam® COLON 2 Capsule; Procedure: Colonoscopy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia
    • Recruiting
    • Military University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Pillcam® COLON 2 Capsule and colonoscopy; 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; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Military University Hospital, Prague
• Collaborators: Institute for Clinical and Experimental Medicine; Masaryk University; University Hospital Hradec Kralove
• Investigators: Study Director: Stepan Suchanek, Military University Hospital, Prague

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ANTICIPATED): December 31, 2019
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (ACTUAL): February 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: colorectal cancer; colonoscopy; screening; colon capsule
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: 16-29614A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No