Abstract

To assess the feasibility, accuracy and acceptability of PillCam Colon 2 in detection of significant lesions in colorectal cancer risk patients, unable or unwilling to perform colonoscopy. This is a prospective, single center study using the second generation of PillCam Colon capsule. In all patients the readers were instructed to review the entire colon capsule endoscopy (CCE) examination using Rapid 7 software and additionally to note significant extra-colonic findings. Colonic significant findings were described according to European Society of Gastrointestinal Endoscopy guidelines. CCE procedure completion rate, level of bowel preparation and rate of adverse events were assessed. A total of 70 patients at risk of colorectal cancer were enrolled in the study. In three patients the procedure failed because the capsule was not functioning when entered the colon. PillCam Colon 2 showed positive findings in 23 (34%, 95%CI: 21.6%-44.1%) of the remaining 67 patients. Six patients were diagnosed with tumors: 4 with colon cancers, 1 with gastric cancer and 1 with a small bowel cancer. The capsule findings were confirmed after surgery in all these patients. The capsule excretion rate in twelve hours was 77% with 54 patients having a complete examination. The rectum was not explored during CCE procedure, in 16 patients (23%, 95%CI: 13.7%-34.1%). Every patient accepted CCE as an alternative exploration tool and 65/70 (93%) agreed to have another future control by CCE. No complications were reported during or after CCE examination. PillCam Colon 2 capsule was effective in detecting significant lesions and might be considered an adequate alternative diagnostic tool in patients unable or unwilling to undergo colonoscopy.

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