Evaluation of a new pan-enteric video capsule endoscopy system in patients with suspected or established inflammatory bowel disease – feasibility study
submitted 05. März 2018
accepted after revision 30. Mai 2018
08. Oktober 2018 (online)
Background and study aims Inflammatory bowel disease (IBD) affects the small bowel and colon. Endoscopic evaluation of these organs is essential. The new pan-enteric Crohn’s capsule (PCC) system is customized for complete coverage of IBD lesions in the entire bowel, allowing assessment and follow-up of disease severity and extent. The aim of this study was to evaluate the functionality of the PCC system in patients with suspected or established IBD.
Patients and methods This was a prospective five-center feasibility study assessing the performance of PCC. Subjects ingested PCC after patency assurance with standard bowel preparation plus boosts. The primary endpoint was successful procedure, that is, video creation and report generation in accordance with methodology. Secondary endpoints were subjective coverage of the entire bowel, duration of reading time, video quality and occurrence of adverse events.
Results Forty-one patients were included in the study with a mean age of 40.8 years ± 15.5, 46 % of whom were males. Seventy-one percent of patients had established Crohn’s disease (CD) and 53 % had active disease. Cleansing was graded good/excellent in 95 %. All 41 videos met the primary endpoint. There was no retention, 83 % reached the toilet while still recording. Thirty-one percent of patients with CD had proximal disease. Bowel coverage was graded 6.7 ± 0.6 and 6.1 ± 1.3 (1 – 7, unconfident – confident), image quality 6.1 ± 0.8 (1 – 7, poor – excellent), and reading time 3.7 ± 1.4 (1 – 7, very short to very long).
Conclusions The PCC system is a minimally invasive system allowing extensive evaluation of the entire bowel in patients with IBD.
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