Akira Kurita1, Satoru Yasukawa2, Yoh Zen3, Kenichi Yoshimura4, Takeshi Ogura5, Eisuke Ozawa6, Yoshinobu Okabe7, Masanori Asada8, Hiroko Nebiki9, Minoru Shigekawa10, Tsukasa Ikeura11, Takaaki Eguchi12, Hirotsugu Maruyama13, Toshiharu Ueki14, Masahiro Itonaga15, Shinichi Hashimoto16, Hideyuki Shiomi17, Ryuki Minami18, Noriyuki Hoki19, Mamoru Takenaka20, Yoshio Itokawa21, Norimitsu Uza22, Shunpei Hashigo23, Hiroaki Yasuda24, Ryoji Takada25, Hideki Kamada26, Hirofumi Kawamoto27, Hiroshi Kawakami28, Ichiro Moriyama29, Koichi Fujita30, Hisakazu Matsumoto31, Keiji Hanada32, Tadamasa Takemura33, Shujiro Yazumi1. 1. Department of Gastroenterology and Hepatology, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan. 2. Department of Pathology, Kyoto Second Red Cross Hospital, Kyoto, Japan. 3. Institute of Liver Studies, King's College Hospital, Denmark Hill, London, United Kingdom. 4. Innovative Clinical Research Center, Kanazawa University Hospital, Ishikawa, Japan. 5. 2nd Department of Internal Medicine, Osaka Medical College, Osaka, Japan. 6. Department of Gastroenterology and Hepatology, Nagasaki University Hospital, Nagasaki, Japan. 7. Division of Gastroenterology, Department of Medicine, Kurume University, Fukuoka, Japan. 8. Department of Gastroenterology and Hepatology, Japanese Red Cross Osaka Hospital, Osaka, Japan. 9. Department of Gastroenterology, Osaka City General Hospital, Osaka, Japan. 10. Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan. 11. The Third Department of Internal Medicine, Kansai Medical University, Osaka, Japan. 12. Department of Gastroenterology and Hepatology, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan. 13. Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan. 14. Department of Gastroenterology, Fukuoka University Chikushi Hospital, Fukuoka, Japan. 15. Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan. 16. Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan. 17. Division of Gastroenterology, Department of Internal Medicine, Graduate School of Medicine, Kobe University, Hyogo, Japan. 18. Department of Gastroenterology, Tenri Hospital, Nara, Japan. 19. Division of Gastroenterology and Hepatology, Bell Land General Hospital, Sakai, Japan. 20. Departments of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan. 21. Digestive disease Center, Department of Gastroenterology & Hepatology, Kyoto Katsura Hospital, Kyoto, Japan. 22. Department of Gastroenterology and Hepatology, Kyoto University Graduate School of Medicine, Kyoto, Japan. 23. Department of Gastroenterology and Hepatology, Graduate School of Medical Sciences Kumamoto University, Kumamoto, Japan. 24. Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine Graduate School of Medical Science, Kyoto, Japan. 25. Department of Hepatobiliary and Pancreatic Oncology, Osaka International Cancer Institute, Osaka, Japan. 26. Department of Gastroenterology and Neurology, Kagawa University, Kagawa, Japan. 27. Department of General Internal Medicine 2, Kawasaki Medical School, Okayama, Japan. 28. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan. 29. Innovative Cancer Center, Shimane University Hospital, Shimane, Japan. 30. Department of Gastroenterology, Yodogawa Christian Hospital, Osaka, Japan. 31. Department of Gastroenterology and Hepatology, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan. 32. Department of Gastroenterology, Onomichi General Hospital, Onomichi, Japan. 33. Graduate School of Applied Informatics, University of Hyogo, Hyogo, Japan.
Abstract
BACKGROUND AND AIMS: Histologic diagnosis of autoimmune pancreatitis (AIP) using EUS-guided FNA (EUS-FNA) is difficult. To address this issue, new fine-needle biopsy (FNB) needles were recently developed. Here, we prospectively evaluated 2 newly designed EUS-FNB needles for histologic evaluation in patients with type 1 AIP. METHODS: This was a prospective, randomized, multicenter trial comparing biopsy specimens obtained with a 22-gauge Franseen needle or a 20-gauge forward-bevel needle in patients with suspected type 1 AIP. AIP was diagnosed according to international consensus diagnostic criteria. The primary endpoint was the sensitivity of EUS-FNB needles, and secondary endpoints were the amount of specimen obtained, histology of the pancreas based on evaluation of lymphoplasmacytic sclerosing pancreatitis (LPSP), and contribution of histologic findings to the diagnosis of AIP. RESULTS:One hundred ten patients were randomly assigned to the Franseen group (22-gauge Franseen needle) or the forward-bevel group (20-gauge forward-bevel needle). EUS-FNB sampling was successful in all patients. Nine patients were excluded because of diagnoses other than AIP. Compared with the forward-bevel needle, the Franseen needle obtained a significantly greater number of high-power fields. Of 101 patients, 39 patients (78%) in the Franseen group and 23 patients (45%) in the Forward-bevel group were diagnosed with level 1 or 2 LPSP (P = .001). Thirty-six patients could not be diagnosed with type 1 AIP without EUS-FNB specimen results. CONCLUSIONS: The 22-gauge Franseen needle should be routinely used for histologic diagnosis of type 1 AIP. (Clinical trial registration number: UMIN 000027668.).
RCT Entities:
BACKGROUND AND AIMS: Histologic diagnosis of autoimmune pancreatitis (AIP) using EUS-guided FNA (EUS-FNA) is difficult. To address this issue, new fine-needle biopsy (FNB) needles were recently developed. Here, we prospectively evaluated 2 newly designed EUS-FNB needles for histologic evaluation in patients with type 1 AIP. METHODS: This was a prospective, randomized, multicenter trial comparing biopsy specimens obtained with a 22-gauge Franseen needle or a 20-gauge forward-bevel needle in patients with suspected type 1 AIP. AIP was diagnosed according to international consensus diagnostic criteria. The primary endpoint was the sensitivity of EUS-FNB needles, and secondary endpoints were the amount of specimen obtained, histology of the pancreas based on evaluation of lymphoplasmacytic sclerosing pancreatitis (LPSP), and contribution of histologic findings to the diagnosis of AIP. RESULTS: One hundred ten patients were randomly assigned to the Franseen group (22-gauge Franseen needle) or the forward-bevel group (20-gauge forward-bevel needle). EUS-FNB sampling was successful in all patients. Nine patients were excluded because of diagnoses other than AIP. Compared with the forward-bevel needle, the Franseen needle obtained a significantly greater number of high-power fields. Of 101 patients, 39 patients (78%) in the Franseen group and 23 patients (45%) in the Forward-bevel group were diagnosed with level 1 or 2 LPSP (P = .001). Thirty-six patients could not be diagnosed with type 1 AIP without EUS-FNB specimen results. CONCLUSIONS: The 22-gauge Franseen needle should be routinely used for histologic diagnosis of type 1 AIP. (Clinical trial registration number: UMIN 000027668.).
Authors: Diogo T H de Moura; Thomas R McCarty; Pichamol Jirapinyo; Igor B Ribeiro; Kelly E Hathorn; Antonio Coutinho Madruga-Neto; Linda S Lee; Christopher C Thompson Journal: Endosc Int Open Date: 2020-05-25
Authors: Kofi W Oppong; Pardeep Maheshwari; Manu K Nayar; Antony Darne; Daniel Parkinson; John S Leeds; Beate Haugk Journal: Endosc Int Open Date: 2020-11-27
Authors: Jintao Guo; Anand V Sahai; Anthony Teoh; Paolo Giorgio Arcidiacono; Alberto Larghi; Adrian Saftoiu; Ali A Siddiqui; Brenda Lucia Arturo Arias; Christian Jenssen; Douglas G Adler; Sundeep Lakhtakia; Dong-Wan Seo; Fumihide Itokawa; Marc Giovannini; Girish Mishra; Luis Sabbagh; Atsushi Irisawa; Julio Iglesias-Garcia; Jan Werner Poley; Juan J Vila; Lachter Jesse; Kensuke Kubota; Evangelos Kalaitzakis; Mitsuhiro Kida; Mohamed El-Nady; Sh Untaro Mukai; Takeshi Ogura; Pietro Fusaroli; Peter Vilmann; Praveer Rai; Nam Q Nguyen; Ryan Ponnudurai; Chalapathi Rao Achanta; Todd H Baron; Ichiro Yasuda; Hsiu-Po Wang; Jinlong Hu; Bowen Duan; Manoop S Bhutani; Siyu Sun Journal: Endosc Ultrasound Date: 2020 Sep-Oct Impact factor: 5.628