Masanao Nakamura1, Kenji Watanabe2,3, Naoki Ohmiya4, Fumihito Hirai5, Teppei Omori6, Daisuke Tokuhara7, Konosuke Nakaji8, Sadaharu Nouda9, Motohiro Esaki10, Yukinori Sameshima11, Hidemi Goto1,12, Akira Terano13, Hisao Tajiri14, Toshiyuki Matsui15. 1. Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Aichi, Japan. 2. Department of Gastroenterology, Graduate School of Medicine, Osaka City University, Osaka, Japan. 3. Department of Intestinal Inflammation Research, Hyogo College of Medicine, Hyogo, Japan. 4. Department of Gastroenterology, Fujita Health University School of Medicine, Aichi, Japan. 5. Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan. 6. Institute of Gastroenterology, Tokyo Women's Medical University, Tokyo, Japan. 7. Department of Pediatrics, Graduate School of Medicine, Osaka City University, Osaka, Japan. 8. Endoscopy Center, Aishinkai Nakae Hospital, Wakayama, Japan. 9. Second Department of Internal Medicine, Osaka Medical College, Osaka, Japan. 10. Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 11. Sameshima Hospital, Kagoshima, Japan. 12. Department of Gastroenterology, Meijo Hospital, Aichi, Japan. 13. Dokkyo Group of Academic Institutions, Tochigi, Japan. 14. Department of Innovative Interventional Endoscopy Research, The Jikei University School of Medicine, Tokyo, Japan. 15. Department of Gastroenterology, Fukuoka University Chikushi Hospital, Fukuoka, Japan.
Abstract
STUDY AIMS: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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).
STUDY AIMS: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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).