Trial Information

A New Method for Colorectal Cancer Screening: Colon Capsule Endoscopy Compared to Conventional Endoscopy

Study design This was a prospective, single center pilot analysis under screening
conditions. Patient enrollment was from November 5, 2007, to May 7, 2008. All patients
provided written informed consent. Patients underwent CCE on day 1 and conventional
colonoscopy on day 2, the examinations were done by different physicians. Results were
blinded until both examinations had been completed and until interobserver evaluation was
finished. Patient acceptance was assessed with a questionnaire after completion of both
examinations.

This study was approved by the ethics committee. The study was partly funded by the Nycomed
Fund of the University Hospital Basel, Switzerland and by Given Imaging Ltd., Yoqneam,
Israel).

The authors designed the study, gathered and analyzed the data; the sponsors had no role in
design or conduct of the study nor did they review or approve the data.

Patients Men and women above the age of 50 years without symptoms (Indication for screening)
or with lower gastrointestinal signs and symptoms and individuals younger than 50 years,
minimum 18 years, without symptoms but with a positive family history for colorectal cancer
(CRC) (Indication for screening) were considered for this study. Exclusion criteria were CRC
in the patient's history, cardiac pacemaker, contraindications for sodium phosphate solution
(Colophos®) and risk factors for capsule retention including surgical intestinal
anastomosis, Crohn's disease, diverticulitis and radiologically suspected bowel obstruction.

Data collection General characteristic of the patients were assembled, including
demographics, family history and recent surgery, as well as bowel habits.

Hypothesis, Aim and End Points Significance was defined as polyps >5mm in size, with the
hypothesis that detection rate on CCE corresponds with colonoscopy. The aim was to evaluate
a novel method (colon capsule endoscopy) for performance as a screening tool compared to
conventional colonoscopy in asymptomatic patients. The proclaimed benefit would be an
increase in acceptance of screening for colorectal cancer and a probable better detection
rate of adenoma resp. carcinoma.

The primary endpoint was the number of cancerous lesions and polyps detected on CCE compared
to conventional colonoscopy. Secondary endpoints were completeness of the exam completeness,
patient acceptance and adherence to preparation regimen.

Colon preparation and Propulsion of the Capsule For colon cleansing we applied our
department's standard preparation procedure for conventional colonoscopy including diet and
Macrogolum (PEG, Cololyt®; Spirig Pharma, Egerkingen, Switzerland) and added an oral
motility agent, Phospho Soda (Colophos®; Spirig Pharma, Egerkingen, Switzerland)-boosters
and a rectal suppository that promotes defecation, Table 1. Patients started with a low
residual diet three days prior to the PillCam® Colon examination. The following day they
were required to adhere to a liquid diet and one day before the examination to a clear
liquid diet. The evening before the examination they ingested 2 litres of Cololyt® between
18:00 and 19:30 and continued with another 2 litres the next morning between 7:00 and 8:30.
At 11:00 they were given 2 tablets of Domperidon (Motilium®; Janssen-Cilag AG, Baar,
Switzerland) 10mg a couple of minutes prior to the PillCam® Colon capsule. Propulsion from
stomach to small bowel was verified using real time viewing before giving the first
Colophos® booster (45 ml). That we later abandoned (for the remaining 49 patients) due to
satisfactory propulsion. If the capsule had not been excreted by 17:00 (3 hours after the
first dose) a second dose of 30 ml Colophos® was added. If it still had not been excreted by
19:30, a suppository of Bisacodylum 10 mg (Prontolax®; Streuli Pharma, Uznach, Switzerland)
was administered. The patient removed electrodes and recorder-belt at the excretion of the
capsule or at 22:00, which ever came first, and continued clear liquid diet until the
conventional colonoscopy was performed the following day.

Pillcam Colon Capsule The PillCam® Colon Capsule is 11mm x 31mm in size (Figure 1). It is
equipped with two cameras acquiring pictures from both ends of the capsule at a rate of 4
frames per second (2 pictures per second and camera). Compared to the PillCam® Small Bowel
capsule the optic is optimized and more than double of the area coverage and depth view are
provided. The PillCam® Colon Capsule is automatically activated when it is removed from the
package. It enters sleeping mode in order to save energy after approximately 10 minutes and
starts transmitting again 1 h 45 min later. It has a total operating time of 8 - 10 hours.
During the examination the patient wears a sensor array which is attached to the abdominal
skin and a data recorder for storage of the information generated by the ingested capsule.
After the examination the data are downloaded into the Given Imaging workstation and a video
is generated.