Nakamura Masanao, Watanabe Kenji, Ohmiya Naoki, Hirai Fumihito, Omori Teppei, Tokuhara Daisuke, Nakaji Konosuke, Nouda Sadaharu, Esaki Motohiro, Sameshima Yukinori, Goto Hidemi, Terano Akira, Tajiri Hisao, Matsui Toshiyuki
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Aichi, Japan.
Department of Gastroenterology, Graduate School of Medicine, Osaka City University, Osaka, Japan.
Dig Endosc. 2021 Jan;33(1):151-161. doi: 10.1111/den.13673. Epub 2020 Jun 24.
The PillCam patency capsule (PPC) is an Agile tag-less patency capsule used to evaluate gastrointestinal (GI) patency. We determined the appropriate use of PPC to preclude subsequent small bowel capsule endoscopy (SBCE) retention.
This prospective multicenter study consecutively enrolled patients indicated for SBCE with suspected or established small bowel stenosis. Excretion of an intact PPC or its radiologic visualization in the large bowel was considered GI patency. Primary and secondary study endpoints were SBCE retention rates in patients with confirmed patency and identification of factors associated with patency and SBCE retention, respectively.
Of 1096 patients enrolled in the study, patency was confirmed in 976 (89.1%). PPC excretion occurred in 579 patients. Of the remaining 517 patients, patency was confirmed using imaging modalities in 401 (77.5%). SBCE retention occurred in five (0.51%) of 963 patients who underwent SBCE: 1.0% in established Crohn's disease (CD) patients, 0% in suspected CD, 0% in tumors, and 1.6% in patients with obscure GI bleeding, for which PPC localization had been radiographically misinterpreted. The non-confirmation of patency was associated with established CD, stenosis identified using imaging modalities, abdominal fullness, serum albumin levels <4.0 g/dL, and previous small bowel obstruction (adjusted odds ratios: 4.21, 2.60, 2.47, 2.12, and 2.00; 95% confidence intervals: 2.62-6.78, 1.62-4.17, 1.43-4.27, 1.32-3.40, and 1.15-3.47, respectively).
The PillCam™ patency capsule helped preclude SBCE retention in most patients, but its accurate localization was essential for cases without excretion (Study registered the University Hospital Medical Information Network, #UMIN000010513).
PillCam通畅胶囊（PPC）是一种用于评估胃肠道（GI）通畅性的无敏捷标签的通畅胶囊。我们确定了PPC的适当使用方法，以避免随后的小肠胶囊内镜检查（SBCE）滞留。
这项前瞻性多中心研究连续纳入了因怀疑或确诊小肠狭窄而需要进行SBCE的患者。完整的PPC排出或其在大肠中的放射学显影被视为胃肠道通畅。主要和次要研究终点分别是通畅患者的SBCE滞留率以及确定与通畅和SBCE滞留相关的因素。
在纳入研究的1096例患者中，976例（89.1%）被确认为通畅。579例患者出现PPC排出。在其余517例患者中，401例（77.5%）通过成像方式确认为通畅。在963例接受SBCE的患者中发生了5例（0.51%）SBCE滞留：确诊克罗恩病（CD）的患者中为1.0%，疑似CD患者中为0%，肿瘤患者中为0%，不明原因胃肠道出血患者中为1.6%，这些患者的PPC定位在放射学上被错误解读。通畅未得到确认与确诊的CD、通过成像方式确定的狭窄、腹部饱胀、血清白蛋白水平<4.0 g/dL以及既往小肠梗阻有关（调整后的优势比分别为：4.21、2.60、2.47、2.12和2.00；95%置信区间分别为：2.62 - 6.78、1.62 - 4.17、1.43 - 4.27、1.32 - 3.40和1.15 - 3.47）。
PillCam™通畅胶囊有助于在大多数患者中避免SBCE滞留，但对于未排出的情况，其准确定位至关重要（该研究已在大学医院医学信息网络注册，#UMIN000010513）。
