Assessing accuracy of PillCam Colon 2 in a screening setting

Objectives, structure and design of the Study

Study design

Diagnostic accuracy study assessing the performance of the new PillCam Colon device in a homogeneous study population of subjects, aged 55 to 69, referred for colonoscopy following a positive result at FIT screening. All who will give their consent to be enrolled, will perform the CCE followed by total colonoscopy in the same day. Colonoscopy results will be the reference standard for evaluating diagnostic accuracy of CCE.

Primary objective

The main aim of the study is to assess the accuracy (sensitivity and specificity) and the positive and negative predictive value (PPV and NPV) of PillCam Colon 2, compared to conventional colonoscopy, in detecting CRC and advanced adenomas, among subjects with a positive FIT, attending in an organised population screening programme.

Secondary objectives

  • To assess the potential role of CCE as a primary screening test or as a triage test to select subjects who need to be referred for colonoscopy assessment and eventually polypectomy.
  • To assess CCE sensitivity and specificity by location (distal versus proximal colon) of advanced adenomas and CRC.
  • per-polyp analysis
  • the feasibility and organizational impact of the QUICK view reading in the interval between capsule egestion and the start of the OC examination, when using capsule as a triage test for colonoscopy referral

Based on the exams data-base, issues related to reading reliability and quality can be assessed as well:

  • The accuracy of a reading strategy which would involve stopping the CCE film review as soon as the positivity criterion has been met (i.e a polyp of the pre-specified size has been visualised), to simulate a possible feasible and efficient approach in a screening context.
  • the accuracy and reproducibility of the reading when performed by gastroenterologists, other physicians (non gastroenterologists) and nurses
  • the validation of the QUICK view reading modality as compared to the standard complete film reading; 20% QV will be used to learn about future opportunities of QuickView

Sample size

440 Patients

Primary variable

Detection rate of advanced adenomas and CRC using different positivity thresholds with CCE

Number of Centers and location of the Study

5 Centers in Italy

Study duration

2 anni based on the following assumptions:

  1. Sviluppo algoritmo di identificazione dei casi incidenti e identificazione degli episodi di cura successivi: 15 giorni
  2. Richiesta, raccolta e archiviazione cartelle cliniche: 3 mesi
  3. Estrazione dati e compilazione database: 12 mesi
  4. Analisi dei dati e scrittura del report: 3 mesi

Study start date

Dicembre 2013