Evaluation of a new pan-enteric video capsule endoscopy system in patients with suspected or established inflammatory bowel disease – feasibility study

Abstract

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.

Usefulness of panoramic 344°-viewing in Crohn’s disease capsule endoscopy: a proof of concept pilot study with the novel PillCam™ Crohn’s system

“…This proof of concept pilot multi-center study carried out in routine clinical practice confirms that the novel PillCam™ Crohn's system is safe and provides high technical and endoscopic performances for CD assessment [12,14]. Our results also suggest that the panoramic 344°-view clearly improves small-bowel capsule visualisation, thus potentially improving both diagnostic accuracy and clinical management for patients undergoing small bowel CE for suspected or established CD.…”

“…A recent pilot study has suggested that PCS would possibly result in higher diagnostic yields than ileo-colonoscopy in patients with known a New diagnosis of CD was defined for relevant CE findings strongly supporting a definite diagnosis following a 6-months follow-up active CD following a capsule colon cleansing protocol [12]. PCS showed to be safe and to enable the direct evaluation of the entire gut based on the preliminary data from a proof-of-concept feasibility study conducted on CD and ulcerative colitis patients [14].…”

“…This system includes a dual-camera capsule device with prolonged battery life potentially allowing for pan-enteric wireless capsule endoscopy and an optimized platform specifically designed to assess IBD mucosal disease severity and extent over time. Technical details of the PCS have been recently described in detail elsewhere [14].…”

“…The Lewis Score (LS) was calculated to assess the small-bowel CD diagnosis and activity. Briefly, the LS uses the CE structured terminology (edema, ulcer, and strictures) to grade disease activity into three levels: i) no or clinically insignificant (LS < 135); ii) mild (135 ≤ LS ≤790); iii) moderate to severe (LS > 790) [14,15]. Peptic disorders, vascular and inflammatory lesions were assessed following established classifications [16][17][18].…”

Endoscopic ultrasonography and small‐bowel endoscopy: Present and future

“…[157][158][159][160][161][162] The advent of capsule devices with a prolonged operating time has recently opened the era of pan-intestinal CE. 159,162 This all-in-one and on-demand approach has a promising application in IBD 159,[162][163][164][165] where it can supposedly speed up the diagnostic work-up and decrease the need for endoscopic procedures. However, the evidence so far collected on this novel approach is very limited.…”