Journal Article

Prospective randomized study of endoscopic biliary stone extraction using either a basket or a balloon catheter: the BasketBall study

Shinpei Doi, Issei Kojima, Koichiro Matsuda, Ichiro Yasuda, Yusuke Ishida, Tsuyoshi Mukai, Nobuhiro Ando, Yoshinobu Okabe, Tesshin Ban, Noritaka Ozawa, Masanori Nakashima, Takuji Iwashita, Masahito Shimizu, Mitsuru Matsuda, Keisuke Iwata

2017

Overview

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.

• Publisher: Springer Science and Business Media LLC,Springer Japan,Springer,Springer Nature B.V
• Subject: Abdominal Surgery / Adult / Aged / Aged, 80 and over / Biliary Tract / Catheters / Cholangiopancreatography, Endoscopic Retrograde / Cholangiopancreatography, Endoscopic Retrograde - adverse effects / Cholangiopancreatography, Endoscopic Retrograde - instrumentation / Cholangiopancreatography, Endoscopic Retrograde - methods / Colorectal Surgery / Comparative analysis / Female / Gallstones / Gallstones - diagnostic imaging / Gallstones - pathology / Gallstones - surgery / Gastroenterology / Hepatology / Humans / Male / Medical research / Medicine / Medicine & Public Health / Medicine, Experimental / Middle Aged / Original Article—Liver / Pancreas / Prospective Studies / Risk Factors / Sphincterotomy, Endoscopic / Sphincterotomy, Endoscopic - instrumentation / Sphincterotomy, Endoscopic - methods / Surgical Oncology / Treatment Failure