Kazunori Eto1, Hiroshi Kawakami2, Shin Haba3, Hiroaki Yamato4, Toshinori Okuda5, Kei Yane6, Tsuyoshi Hayashi7, Nobuyuki Ehira8, Manabu Onodera9, Ryusuke Matsumoto10, Yu Matsubara11, Tomofumi Takagi12, Naoya Sakamoto13. 1. Department of Gastroenterology, Tomakomai City Hospital, Tomakomai, Hokkaido, Japan. 2. Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan. hiropon@med.hokudai.ac.jp. 3. Department of Gastroenterology, NTT East Japan Sapporo Hospital, Sapporo, Hokkaido, Japan. 4. Department of Gastroenterology, Municipal Hakodate Hospital, Hakodate, Hokkaido, Japan. 5. Department of Gastroenterology, Oji General Hospital, Tomakomai, Hokkaido, Japan. 6. Center for Gastroenterology, Teine-Keijinkai Hospital, Sapporo, Hokkaido, Japan. 7. Department of Medical Oncology and Hematology, Sapporo Medical University Hospital, Sapporo, Hokkaido, Japan. 8. Department of Gastroenterology, Japanese Red Cross Kitami Hospital, Kitami, Japan. 9. Department of Internal Medicine and Gastroenterology, Abashiri-Kosei General Hospital, Abashiri, Hokkaido, Japan. 10. Third Department of Internal Medicine, Obihiro Kosei General Hospital, Obihiro, Hokkaido, Japan. 11. Gastroenterology Center, Sapporo Higashi Tokushukai Hospital, Sapporo, Hokkaido, Japan. 12. Department of Gastroenterology, Sapporo Hokushin Hospital, Sapporo, Hokkaido, Japan. 13. Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Hokkaido, Japan.
Abstract
BACKGROUND: Two-stage treatment involving stone removal after drainage is recommended for mild to moderate acute cholangitis associated with choledocholithiasis. However, single-stage treatment has some advantages. We aimed to assess the efficacy and safety of single-stage endoscopic treatment for mild to moderate acute cholangitis associated with choledocholithiasis. METHODS: A multicenter, non-randomized, open-label, exploratory clinical trial was performed in 12 institutions. A total of 50 patients with a naïve papilla and a body temperature ≥37 °C who were diagnosed with mild to moderate cholangitis associated with choledocholithiasis were enrolled between August 2012 and February 2014. RESULTS: Of the 50 patients, 15 had mild cholangitis and 35 had moderate cholangitis. The median number of common bile duct stones was 2 (range, 1-8), and the median diameter of the common bile duct stones was 7.5 mm (range, 1-18). The cure rate of acute cholangitis within 4 days after single-stage treatment was 90% (45/50) based on a body temperature <37 °C for ≥24 h. The incidence of complications was 10% (5/50). CONCLUSION: Single-stage endoscopic treatment may be effective and safe for mild to moderate acute cholangitis associated with choledocholithiasis (clinical trial registration number: UMIN000008494).
BACKGROUND: Two-stage treatment involving stone removal after drainage is recommended for mild to moderate acute cholangitis associated with choledocholithiasis. However, single-stage treatment has some advantages. We aimed to assess the efficacy and safety of single-stage endoscopic treatment for mild to moderate acute cholangitis associated with choledocholithiasis. METHODS: A multicenter, non-randomized, open-label, exploratory clinical trial was performed in 12 institutions. A total of 50 patients with a naïve papilla and a body temperature ≥37 °C who were diagnosed with mild to moderate cholangitis associated with choledocholithiasis were enrolled between August 2012 and February 2014. RESULTS: Of the 50 patients, 15 had mild cholangitis and 35 had moderate cholangitis. The median number of common bile duct stones was 2 (range, 1-8), and the median diameter of the common bile duct stones was 7.5 mm (range, 1-18). The cure rate of acute cholangitis within 4 days after single-stage treatment was 90% (45/50) based on a body temperature <37 °C for ≥24 h. The incidence of complications was 10% (5/50). CONCLUSION: Single-stage endoscopic treatment may be effective and safe for mild to moderate acute cholangitis associated with choledocholithiasis (clinical trial registration number: UMIN000008494).