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Assessing accuracy of PillCam Colon 2 in a screening setting: a prospective study in Italy

ABSTRACT: Background and study aims Colon capsule endoscopy is a new technique to look at the colon. The patient swallows a capsule that is slightly bigger than an antibiotic pill. The capsule has two small cameras that can send images of the colon to an external data-recorder where the video of the examination can be stored and examined after capsule excretion. The aim of this study is to find out how accurate a new capsule is at detecting colorectal cancer and advanced adenomas. Who can participate? People aged 55 to 69 attending an organized population screening program, who had a positive test result at the screening test (fecal occult blood test). What does the study involve? Subjects who consent to be enrolled are required to follow a specific oral bowel preparation starting 2 days before the planned appointment. In the morning of the exam day, after completing the last part of the preparation, the patients will swallow the capsule. A colonoscopy will be performed following the usual procedure after the excretion of the capsule.

DISEASE(S): Colorectal Cancer

PROVIDER: 2420875 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Colorectal cancer (CRC) is the second most common cause of cancer-related death in the Western world, with 500000 deaths per year worldwide. Colonoscopy is accepted as a primary CRC screening tool in many countries. As a preventative procedure, its main purpose is to enable the early diagnosis of CRC at a curable stage and to identify and remove pre-malignant adenomas. Cecal intubation is associated with an increased detection rate of advanced neoplasia, as 33-50% of advanced neoplasia is located in the proximal colon. Complete colonic evaluation is therefore a well-recognized measure of colonoscopy quality control. Cecal intubation rates of ≥ 90% of all colonoscopies in routine clinical practice and ≥ 95% in screening colonoscopies are recommended. Unfortunately, the cecal intubation rate in daily clinical practice is often lower than the target of ≥ 90%, with reported percentages varying from 76.9% to 98.4%. This means that after an incomplete colonoscopy, malignant and pre-malignant lesions may be missed if further investigation is not pursued. Several explanatory factors for incomplete colonoscopy have been described. After an incomplete conventional colonoscopy, patients are required to undergo another test to complete the visualization of the colon. Options for incomplete examinations because of anatomic reasons include both radiologic and endoscopic means. CT Colonography (CTC ) permits to visualise the whole colon, is minimally invasive, does not require sedation and is well accepted by the patient. The PillCam Colon Capsule Endoscopy (Given Diagnostic System)offers an alternative approach for endoscopic visualization of the colon in patients with an incomplete conventional colonoscopy. Advantages of the PillCam Colon Capsule Endoscopy (PCCE) include the elimination of the need for sedation, the minimally invasive, painless nature of the exam, no need of X-rays and the ability to pursue normal daily activities immediately following the procedure. This is a study that is designed to evaluate the performance of the PCCE in the evaluation of patients with an incomplete colonoscopy, compared to the CT-colonography. PCCE and CT-colonography procedures will be compared in regards to completeness of the procedure and detection of lesions in the colon that would have been missed by the incomplete conventional colonoscopy.

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Assessing accuracy of PillCam Colon 2 in a screening setting: a prospective study in Italy

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