Yojiro Sakuma1, Yuzo Kodama2, Yuko Sogabe3, Yoshitaka Nakai4, Yukitaka Yamashita5, Sakae Mikami6, Kozo Kajimura7, Kazuki Ikeda8, Hiroyuki Tamaki9, Satoru Iwamoto10, Fumihiro Matsuda11, Koichi Fujita12, Norimitsu Uza2, Takashi Kawamura13, Shinji Uemoto14, Hiroshi Seno2, Tsutomu Chiba2, Shujiro Yazumi15. 1. Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan; Division of Gastroenterology and Hepatology, Digestive Disease Center, The Tazuke Kofukai Medical Research Institute Kitano Hospital, Osaka, Japan. 2. Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan. 3. Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan; Department of Gastroenterology and Hepatology, Otsu Red Cross Hospital, Otsu, Japan. 4. Department of Gastroenterology and Hepatology, Kyoto Katsura Hospital, Kyoto, Japan. 5. Department of Gastroenterology and Hepatology, Japanese Red Cross Society, Wakayama Medical Center, Wakayama, Japan. 6. Department of Gastroenterology and Hepatology, Kobe City Hospital Organization, Kobe City Medical Center West Hospital, Kobe, Japan. 7. Department of Gastroenterology and Hepatology, Kishiwada City Hospital, Kishiwada, Japan. 8. Department of Gastroenterology and Hepatology, Kansai Denryoku Hospital, Osaka, Japan. 9. Department of Gastroenterology and Hepatology, Takamatsu Red Cross Hospital, Takamatsu, Japan. 10. Department of Gastroenterology and Hepatology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan. 11. Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital, Osaka, Japan. 12. Division of Gastroenterology and Hepatology, Digestive Disease Center, The Tazuke Kofukai Medical Research Institute Kitano Hospital, Osaka, Japan; Kyoto University Health Service, Kyoto, Japan; Department of Gastroenterology, Yodogawa Christian Hospital, Osaka, Japan. 13. Kyoto University Health Service, Kyoto, Japan. 14. Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan. 15. Division of Gastroenterology and Hepatology, Digestive Disease Center, The Tazuke Kofukai Medical Research Institute Kitano Hospital, Osaka, Japan.
Abstract
BACKGROUND AND AIMS: The efficacy of ERCP for histologic diagnosis of malignant biliary strictures is disappointingly low. The aim of this study was to investigate the diagnostic performance of a newly developed endoscopic device with scraping loops in combination with conventional biopsy forceps. METHODS: We performed a multicenter single-arm prospective study. Between February 2013 and December 2014, 123 patients with suspected malignant biliary strictures were enrolled in the study. The new device and conventional biopsy forceps were applied for histologic diagnosis by ERCP. The primary outcome was to evaluate cancer detectability by biopsy forceps, the new device, and their combined use. RESULTS: Of the 123 patients, 119 were diagnosed with a malignant stricture. Sufficient samples were collected in 83.7% (103/123), 93.5% (115/123), and 95.9% (118/123) of patients using biopsy forceps, the new device, and their combination, respectively. Cancer detectability of forceps biopsy, the new device, and their combination were 51.3% (61/119), 64.7% (77/119), and 74.8% (89/119), respectively. The new device had a significantly higher sample yield and cancer detectability than biopsy forceps (P < .01 and P = .018, respectively, McNemar test). Complementary use of the new device with biopsy forceps demonstrated a significantly additive effect in both sample yield and cancer detection (P < .01 each, McNemar test). The new device detected 48.3% (28/58) of cancers that were not diagnosed as malignant by biopsy forceps. CONCLUSIONS: The new endoscopic scraper demonstrated a large sample yield and high cancer detectability. It could be a first-line tissue-sampling device for biliary strictures. (University Hospital Medical Information Network Clinical Trial Registry [UMIN-CTR] (http://www.umin.ac.jp/ctr/index.htm) registration number: UMIN000009895.).
BACKGROUND AND AIMS: The efficacy of ERCP for histologic diagnosis of malignant biliary strictures is disappointingly low. The aim of this study was to investigate the diagnostic performance of a newly developed endoscopic device with scraping loops in combination with conventional biopsy forceps. METHODS: We performed a multicenter single-arm prospective study. Between February 2013 and December 2014, 123 patients with suspected malignant biliary strictures were enrolled in the study. The new device and conventional biopsy forceps were applied for histologic diagnosis by ERCP. The primary outcome was to evaluate cancer detectability by biopsy forceps, the new device, and their combined use. RESULTS: Of the 123 patients, 119 were diagnosed with a malignant stricture. Sufficient samples were collected in 83.7% (103/123), 93.5% (115/123), and 95.9% (118/123) of patients using biopsy forceps, the new device, and their combination, respectively. Cancer detectability of forceps biopsy, the new device, and their combination were 51.3% (61/119), 64.7% (77/119), and 74.8% (89/119), respectively. The new device had a significantly higher sample yield and cancer detectability than biopsy forceps (P < .01 and P = .018, respectively, McNemar test). Complementary use of the new device with biopsy forceps demonstrated a significantly additive effect in both sample yield and cancer detection (P < .01 each, McNemar test). The new device detected 48.3% (28/58) of cancers that were not diagnosed as malignant by biopsy forceps. CONCLUSIONS: The new endoscopic scraper demonstrated a large sample yield and high cancer detectability. It could be a first-line tissue-sampling device for biliary strictures. (University Hospital Medical Information Network Clinical Trial Registry [UMIN-CTR] (http://www.umin.ac.jp/ctr/index.htm) registration number: UMIN000009895.).