COlon Capsule Endoscopy as an AlterNative for CT-colonography in Colorectal Cancer Screening

Since 2014 a nationwide fecal immunochemical test (FIT) based CRC screening
programme has started in the Netherlands. All people between 55-75 years old
are invited to participate. In case of a positive FIT, subjects are referred to
undergo a colonoscopy. However, almost 25% of the participants with a positive
FIT outcome do not undergo a subsequent colonoscopy. Colonoscopy is an invasive
procedure for which sedation is needed, which makes it not possible for
everyone due to contra-indications or patient preferences, and if it is
possible, it is not always possible to complete the whole procedure. In these
cases participants are referred to undergo CT-colonography, a noninvasive
procedure for which no sedation is needed. However, the sensitivity of
CT-colonography is significantly lower than with colonoscopy, especially for
smaller polyps. On top of that, CT-colonography may have harms resulting from
low-dose ionizing radiation exposure or unintentional identification of
extracolonic findings. Colon capsule endoscopy (CCE) is a noninvasive technique
to explore the colon without the need for sedation or radiation exposure. On
top of that, after taking in the colon capsule, the patient can go home again.
The sensitivity of CCE is almost similar to colonoscopy and superior to
CT-colonography, especially for smaller polyps. CCE has also shown to be
effective for detection of additional relevant findings after incomplete
colonoscopies. Several studies have shown that CCE could potentially increase
participation rates among people who decline screening colonoscopy. Despite all
this, CCE is still not a part of the regular screening programme.

The aim of this study will be to evaluate the applicability of using CCE in the
Dutch colorectal cancer screening programme in participants with positive FIT
outcomes who have contra-indications for subsequent colonoscopy, who have a
prior incomplete colonoscopy or who are unwilling to undergo colonoscopy. The
diagnostic yield, participation rate, expected- and perceived burden of using
CCE for the patient, the workability of CCE for the staff and the interobserver
variability between different reviewers will be evaluated.

This study is a prospective, observational cohort study. It is initiated at the
Erasmus MC and has a future perspective to extend to a multicenter study. All
screenees tested FIT positive within the nationwide colorectal cancer screening
programme who have a contra-indication for subsequent colonoscopy, who are
unwilling to undergo colonoscopy or who had a prior incomplete colonoscopy are
invited to participate in this study.
Study information will be given during the intake and the patient information
folder will be handed out together with a notification card. When willing to
participate, the subject sends a positive notification card to the research
team after which the colon capsule endoscopy will be planned. The informed
consent form will be signed by the participant as well as the researcher on the
day of the capsule endoscopy.
For this study, the PillCam® Colon 2 capsule (Medtronic ltd, Brussels) will be
used. The day prior to the procedure bowel preparation and an adjusted diet
should take place. Analysing the CCE findings will be done by either a
specialised company or a qualified specialist, depending on the preferences of
the participating hospital. The hospital can also choose for members of their
personell to get training in reviewing the CCE images. All CCE videos will be
double checked by the EMC team with expertise in CCE reading.
When there are no findings, subjects will be re-invited for FIT within the
national CRC screening programme in 10 years. In case of polyps smaller then
6mm, patients will be advised a surveillance CT-colonography in 3 years. In
case of polyps over 6 mm or colorectal cancer, patients are referred for
colonoscopy. These guidelines are in line with the currently used guideline for
CT-colonography.
Patients expected- and perceived burden will be evaluated by using 2
questionnaires prior and after the CCE procedure.
The workability of CCE for the staff will be evaluated by using a
questionnaire.

Colon capsule endoscopy provides a less invasive procedure than colonoscopy to
screen for colorectal disease in the national screening programme without the
need for sedation, insufflation, exposure to radiation or admission to a
hospital. Colon capsule endoscopy in a safe procedure. The Pillcam Colon 2
capsule is CE-approved. It has a FDA-approval for the use after an incomplete
colonoscopy. In Europe, colon capsule endoscopy is specifically approved as an
option to screen for colorectal cancer in average risk patients or high risk
patients with contra-indications for colonoscopy or who refuse colonoscopy
(ESGE-guidelines). Complications were almost all attributed to bowel cleansing
and/or the result of subsequent colonoscopy. Some case reports raised the
possibility of capsule aspiration or retention in a diverticulum. There are
some contra-indications for CCE in which the procedure could be potentially
less safe, including obstructive symptoms, suspected intestinal strictures,
pregnancy and implantable cardiac devices. This is the reason why these patient
groups are included in our exclusion criteria.