Colon Capsule Endoscopy Compared to Conventional Colonoscopy under Routine Screening Conditions

Julia B Pilz; Susanne Portmann; Shajan Peter; Christoph Beglinger; Lukas Degen

Disclosures

BMC Gastroenterol. 2010;10(56) 

In This Article

Methods

Study Design

This was a prospective, single center pilot analysis comparing the efficacy of CCE against routine screening colonoscopy at a tertiary care center (University Hospital of Basel, Switzerland). Patient enrolment was from November 5, 2007, to May 7, 2008. All patients provided written informed consent. The study was approved by the Ethics Committee and registered at http://www.clinicaltrials.gov (NCT00991003). 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 did not participate in design or conduct of the study nor did they review or approve the data.

Patients and Data Collection

Every patient who presented at or was referred to our center was considered. 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 with positive family history for CRC, minimum 18 years were included in 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.

General patient characteristics were assembled, including demographics, family history and recent surgery, as well as bowel habits. Patient acceptance was assessed with a 5-item questionnaire upon completion of the second examination (Table S1, additional file 1).

Adverse events were recorded on days 1 and 2 of the study. Additionally, some technical data such as completeness of the examinations (inspection of the whole large intestine from ileocoecal valve to anus), colon transit time, location of the capsule at the time of the first Colophos® booster dose and capsule excretion were recorded.

Study Definitions and Outcomes

The aim was to evaluate this novel method (CCE) for performance as a screening tool compared to CSPY in asymptomatic patients under routine screening conditions. The proclaimed benefit would be an increase in acceptance of screening for CRC and an augmented detection rate of adenoma and/or carcinoma. Significance was defined as polyp size >5 mm, with the hypothesis that detection rate on CCE corresponds with results of CSPY. The primary endpoint was the number of cancerous lesions and polyps detected on CCE compared to CSPY. Secondary endpoints were completeness of the exam, patient acceptance and adherence to preparation regimen. Subanalyses regarding effect of bowel preparation on polyp detection on CCE and accuracy of detection with respect to histopathology were performed.

Interventions

Patients underwent CCE on day 1 and CSPY on day 2. The examinations were carried out by different physicians, with blinding of results until both examinations had been completed and until interobserver evaluation was finished. CSPY was performed by one of eight different gastroenterologists and intubation of the terminal ileum was not required. CCE was read by two of two gastroenterologists at our department. Segmental unblinding was not feasible as the study was performed during the routine setting at a University Hospital.

The PillCam® Colon Capsule is 11 mm × 31 mm in size (Figure 1). It is equipped with two wide-angle (156°) cameras acquiring pictures from both ends of the capsule at a rate of 4 frames per second (2 pictures per second and camera). Activation of the device is automatical on package removal. A sleeping mode of 1 hour 45 minutes is entered upon 10 minutes after ingestion. Detailed procedure has been described elsewhere. Data analysis was performed using RAPID software.

Figure 1.

Original size of PillCam® Colon Capsule 11 mm × 31 mm

The capsule video was read in three steps: identification of anatomical sites was done during "Quick View Mode" at a rate of 20 frames per second. In a second and third step the pictures were read at approximately 8 frames per second as described before. CCE was read only once in order to simulate a routine clinical setting. Detected lesions were reviewed by an additional physician who assessed their presence, size and localisation, with consecutive interobserver agreement.

Standard CSPY with or without polypectomy was performed under Propofol sedation using existing hospital protocols for preparation, and procedural and post-procedural care.[21]

Polyps were estimated by size (greater than 5 mm, ≤5 mm) and location (right or left hemicolon). Polyps detected on CSPY were removed and histologically examined. Other pathologies such as diverticulae, angioectasia and hemorrhoids and their location were also noted but not considered as relevant.

Colon Preparation, Level of Cleansing and Propulsion of the Capsule

For colon cleansing we applied our department's standard preparation procedure for CSPY including low-fibre diet and Macrogolum (PEG, Cololyt®; Spirig Pharma, Egerkingen, Switzerland), and added an oral motility agent (Motilium®; Janssen-Cilag AG, Baar, Switzerland), Phospho Soda-boosters (Colophos®; Spirig Pharma, Egerkingen, Switzerland) and a suppository (Bisacodylum 10 mg, Prontolax®; Streuli Pharma, Uznach, Switzerland), Table 1.

Quality of colon preparation was assesed using a 3 point scale in both CCE and CSPY, Table 2.

Statistical Analysis

CCE was compared to CSPY which was considered to be the gold standard. As this is a pilot study, calculation regarding statistical power did not apply. Sensitivity, specificity, positive predictive value and negative predictive value were calculated per patient, for the included number of patients (n = 56). Percentage values were rounded to the nearest full number. Examinations were excluded from statistical analysis if the capsule had not reached the colon during the recording time. The equivalence between the results of CCE and CSPY was calculated using Wilcoxon signed-rank test and χ2-test. A p-value < 0.05 was considered statistically significant. Baseline characteristics, cause of referral, colonoscopic and capsule-endoscopic findings, technical data and results of the patient questionnaire were documented on a datasheet using Excel (Microsoft, Redmont, Washinton, USA). Statistical analyses were performed using SPSS software package (SPSS Inc., Chicago, Illinois, USA).

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