Noritaka Ozawa1,2, Ichiro Yasuda3,4, Shinpei Doi1,2, Takuji Iwashita2, Masahito Shimizu2, Tsuyoshi Mukai5, Masanori Nakashima5, Tesshin Ban6, Issei Kojima6, Koichiro Matsuda7, Mitsuru Matsuda7, Yusuke Ishida8, Yoshinobu Okabe8, Nobuhiro Ando9, Keisuke Iwata9. 1. Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, 3-8-3 Mizonokuchi, Takatsu-ku, Kawasaki, Kanagawa, 213-8507, Japan. 2. First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan. 3. Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, 3-8-3 Mizonokuchi, Takatsu-ku, Kawasaki, Kanagawa, 213-8507, Japan. yasudaich@gmail.com. 4. First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan. yasudaich@gmail.com. 5. Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan. 6. Department of Gastroenterology, Nagoya Daini Red Cross Hospital, Nagoya, Japan. 7. Department of Gastroenterology, Toyama Prefectural Central Hospital, Toyama, Japan. 8. Department of Gastroenterology, Kurume University, Kurume, Japan. 9. Department of Gastroenterology, Gifu Prefectural Medical Center, Gifu, Japan.
Abstract
BACKGROUND: In Japan and Europe, a retrieval basket is generally used for endoscopic extraction of bile duct stones, while in the US, a retrieval balloon is mainly used. However, the efficacies of these two devices have not been previously compared. Therefore, the present multicenter, prospective, randomized study was performed to compare the efficacies of these two devices for endoscopic biliary stone extraction. METHODS: This study was designed as a non-inferiority study in comparing a basket removal with a balloon removal. Six Japanese institutions participated in this study, which included 184 patients with bile duct stones <11 mm in diameter with no limitation in the number of stones. The stones were identified and measured during ERCP, after which the patients were randomly assigned to undergo endoscopic stone extraction using either a basket catheter or a balloon catheter. The primary end point was the rate of complete removals of stones within 10 min, and the secondary end point was the rate of procedure-related complications. RESULTS: There were 91 patients in the basket group and 93 in the balloon group. The rate of successful stone extraction within 10 min was 81.3 % (74/91) in the basket group and 83.9 % (78/93) in the balloon group (p = 0.7000). The complication rate was 6.6 % in the basket group and 11.8 % in the balloon group (p = 0.3092). Complications included bleeding, pancreatitis, and cholangitis. CONCLUSIONS:Basket and balloon catheters showed similar efficacies for endoscopic biliary stone extraction when stone size is 11 mm or smaller.
RCT Entities:
BACKGROUND: In Japan and Europe, a retrieval basket is generally used for endoscopic extraction of bile duct stones, while in the US, a retrieval balloon is mainly used. However, the efficacies of these two devices have not been previously compared. Therefore, the present multicenter, prospective, randomized study was performed to compare the efficacies of these two devices for endoscopic biliary stone extraction. METHODS: This study was designed as a non-inferiority study in comparing a basket removal with a balloon removal. Six Japanese institutions participated in this study, which included 184 patients with bile duct stones <11 mm in diameter with no limitation in the number of stones. The stones were identified and measured during ERCP, after which the patients were randomly assigned to undergo endoscopic stone extraction using either a basket catheter or a balloon catheter. The primary end point was the rate of complete removals of stones within 10 min, and the secondary end point was the rate of procedure-related complications. RESULTS: There were 91 patients in the basket group and 93 in the balloon group. The rate of successful stone extraction within 10 min was 81.3 % (74/91) in the basket group and 83.9 % (78/93) in the balloon group (p = 0.7000). The complication rate was 6.6 % in the basket group and 11.8 % in the balloon group (p = 0.3092). Complications included bleeding, pancreatitis, and cholangitis. CONCLUSIONS: Basket and balloon catheters showed similar efficacies for endoscopic biliary stone extraction when stone size is 11 mm or smaller.
Authors: John T Maple; Steven O Ikenberry; Michelle A Anderson; Vasundhara Appalaneni; G Anton Decker; Dayna Early; John A Evans; Robert D Fanelli; Deborah Fisher; Laurel Fisher; Norio Fukami; Joo Ha Hwang; Rajeev Jain; Terry Jue; Khalid Khan; Mary Lee Krinsky; Phyllis Malpas; Tamir Ben-Menachem; Ravi N Sharaf; Jason A Dominitz Journal: Gastrointest Endosc Date: 2011-10 Impact factor: 9.427
Authors: Majid A Almadi; Mohanned Eltayeb; Salem Thaniah; Faisal Alrashed; Mohammad A Aljebreen; Othman R Alharbi; Nahla Azzam; Abdulrahman M Aljebreen Journal: Saudi J Gastroenterol Date: 2019 Mar-Apr Impact factor: 2.485