title: Balloon catheter versus basket catheter for endoscopic bile duct stone extraction: a multicenter randomized trial.
abstract: OBJECTIVE
  Endoscopic bile duct stone (BDS) removal is a well-established treatment; however, the preference for basket or balloon catheters for extraction is operator-dependent. We therefore conducted a multicenter prospective randomized trial to compare catheter performance.
  
  
  METHODS
  We enrolled patients with a BDS diameter ≤ 10 mm and common bile duct diameter ≤ 15 mm. Participants were randomly assigned to groups that were treated with basket or balloon catheters between October 2013 and September 2014. The primary endpoint was the rate of complete clearance of the duct; the secondary endpoints were the rate and time to complete clearance in one endoscopic session.
  
  
  RESULTS
  We initially enrolled 172 consecutive patients; 14 were excluded after randomization. The complete clearance rates were 92.3 % (72/78) in the balloon group and 80.0 % (64 /80) in the basket group. The difference in the rates between the two groups was 12.3 percentage points, indicating non-inferiority of the balloon method (non-inferiority limit -10 %; P < 0.001 for non-inferiority). Moreover, the balloon was superior to the basket (P = 0.037). The rate of complete clearance in one endoscopic session was 97.4 % using the balloon and 97.5 % using the basket (P = 1.00). The median times to complete clearance in one endoscopic session were 6.0 minutes (1 - 30) and 7.8 minutes (1 - 37) in the balloon and basket groups, respectively (P = 0.15).
  
  
  CONCLUSIONS
  For extraction of BDSs ≤ 10 mm, complete endoscopic treatment with a single catheter is more likely when choosing a balloon catheter over a basket catheter.University Hospital Medical Information Network Trials Registry: UMIN000011887.
authors.affiliation: Department of Medical Oncology and Hematology, Sapporo Medical University, Sapporo, Japan.
authors.forename: Hirotoshi
authors.initials: H
authors.lastname: Ishiwatari
authors.affiliation: Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kawakami
authors.affiliation: Department of Gastroenterology, Japanese Red Cross Date General Hospital, Date, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Hisai
authors.affiliation: Center for Gastroenterology, Teine-Keijinkai Hospital, Sapporo, Japan.
authors.forename: Kei
authors.initials: K
authors.lastname: Yane
authors.affiliation: Department of Gastroenterology, Abashiri-Kosei General Hospital, Abashiri, Japan.
authors.forename: Manabu
authors.initials: M
authors.lastname: Onodera
authors.affiliation: Department of Gastroenterology, Tomakomai City Hospital, Tomakomai, Japan.
authors.forename: Kazunori
authors.initials: K
authors.lastname: Eto
authors.affiliation: Department of Gastroenterology, NTT East Japan Sapporo Hospital, Sapporo, Japan.
authors.forename: Shin
authors.initials: S
authors.lastname: Haba
authors.affiliation: Department of Gastroenterology, Oji General Hospital, Tomakomai, Japan.
authors.forename: Toshinori
authors.initials: T
authors.lastname: Okuda
authors.affiliation: Department of Gastroenterology, KKR Sapporo Medical Center Tonan Hospital, Sapporo, Japan.
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Ihara
authors.affiliation: Department of Gastroenterology, Rumoi City Hospital, Rumoi, Japan.
authors.forename: Takehiro
authors.initials: T
authors.lastname: Kukitsu
authors.affiliation: Department of Gastroenterology, Obihiro-Kosei General Hospital, Obihiro, Japan.
authors.forename: Ryusuke
authors.initials: R
authors.lastname: Matsumoto
authors.affiliation: Department of Gastroenterology, Otaru Ekisaikai Hospital, Otaru, Japan.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Kitaoka
authors.affiliation: Department of Public Health, Sapporo Medical University School of Medicine, Sapporo, Japan.
authors.forename: Tomoko
authors.initials: T
authors.lastname: Sonoda
authors.affiliation: Department of Medical Oncology and Hematology, Sapporo Medical University, Sapporo, Japan.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Hayashi
mesh_terms: D000368:Aged; D057785:Catheters; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000379:methods; D003135:Common Bile Duct / Q000000981:diagnostic imaging / Q000601:surgery*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D042882:Gallstones / Q000175:diagnosis / Q000601:surgery*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D016717:Sphincterotomy, Endoscopic / Q000295:instrumentation*; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome