title: Prospective randomized study of endoscopic biliary stone extraction using either a basket or a balloon catheter: the BasketBall study.
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.
authors.affiliation: Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, 3-8-3 Mizonokuchi, Takatsu-ku, Kawasaki, Kanagawa, 213-8507, Japan.|First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.
authors.forename: Noritaka
authors.initials: N
authors.lastname: Ozawa
authors.affiliation: Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, 3-8-3 Mizonokuchi, Takatsu-ku, Kawasaki, Kanagawa, 213-8507, Japan. yasudaich@gmail.com.|First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan. yasudaich@gmail.com.
authors.forename: Ichiro
authors.identifier: http://orcid.org/0000-0002-6888-0310
authors.initials: I
authors.lastname: Yasuda
authors.affiliation: Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, 3-8-3 Mizonokuchi, Takatsu-ku, Kawasaki, Kanagawa, 213-8507, Japan.|First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.
authors.forename: Shinpei
authors.initials: S
authors.lastname: Doi
authors.affiliation: First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.
authors.forename: Takuji
authors.initials: T
authors.lastname: Iwashita
authors.affiliation: First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.
authors.forename: Masahito
authors.initials: M
authors.lastname: Shimizu
authors.affiliation: Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Mukai
authors.affiliation: Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan.
authors.forename: Masanori
authors.initials: M
authors.lastname: Nakashima
authors.affiliation: Department of Gastroenterology, Nagoya Daini Red Cross Hospital, Nagoya, Japan.
authors.forename: Tesshin
authors.initials: T
authors.lastname: Ban
authors.affiliation: Department of Gastroenterology, Nagoya Daini Red Cross Hospital, Nagoya, Japan.
authors.forename: Issei
authors.initials: I
authors.lastname: Kojima
authors.affiliation: Department of Gastroenterology, Toyama Prefectural Central Hospital, Toyama, Japan.
authors.forename: Koichiro
authors.initials: K
authors.lastname: Matsuda
authors.affiliation: Department of Gastroenterology, Toyama Prefectural Central Hospital, Toyama, Japan.
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Matsuda
authors.affiliation: Department of Gastroenterology, Kurume University, Kurume, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Ishida
authors.affiliation: Department of Gastroenterology, Kurume University, Kurume, Japan.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Okabe
authors.affiliation: Department of Gastroenterology, Gifu Prefectural Medical Center, Gifu, Japan.
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Ando
authors.affiliation: Department of Gastroenterology, Gifu Prefectural Medical Center, Gifu, Japan.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Iwata
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D057785:Catheters; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D005260:Female; D042882:Gallstones / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D016717:Sphincterotomy, Endoscopic / Q000295:instrumentation* / Q000379:methods; D017211:Treatment Failure
keywords: Balloon catheter; Basket catheter; Biliary stone; Endoscopic extraction