A New Method for Colorectal Cancer Screening: Colon Capsule Endoscopy Compared to Conventional Endoscopy
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Introduction:

      Prevention of colorectal cancer (CRC) is feasible through polypectomy on screening
      colonoscopy. Patient acceptance remains the main limiting factor for execution. Colon capsule
      endoscopy (CCE) might be a novel method for large populations.

      Aims and methods:

      Patients referred for screening means or lower gastrointestinal complaints were included in
      this single center pilot study. They underwent preparation and then ingested the capsule
      (PillCam Colon). Standard colonoscopy was performed the next morning. Significance was
      defined as polyps >5mm in size. Performance of exams was by independent physician with
      blinding of results.
    

Detailed description: 
      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.
    

Intervention name(s): Colon capsule endoscopy; Conventional Colonoscopy
Intervention type(s): Procedure; Procedure
Intervention description(s): The PillCam® Colon Capsule is 11mm x 31mm in size (Figure 1), 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). The PillCam® Colon Capsule is automatically activated when it is removed from the package. It enters sleeping mode 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.
Other intervention name(s): Pillcam Colon Capsule
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Colon Capsule Endoscopy; Colorectal Cancer; Colonoscopy