title: A multicenter, prospective, randomized study of selective bile duct cannulation performed by multiple endoscopists: the BIDMEN study.
abstract: BACKGROUND
  Wire-guided cannulation (WGC) with a sphincterotome (S) for selective bile duct cannulation (SBDC) has been reported to have a higher success rate and lower incidence of post-ERCP pancreatitis (PEP) than conventional methods in some randomized, controlled trials (RCTs) that were both single center and limited to only a few endoscopists.
  
  
  OBJECTIVE
  To estimate the difference in SBDC according to the method and catheter used in a multicenter and multiendoscopist study.
  
  
  METHODS
  A prospective, multicenter RCT with a 2 × 2 factorial design.
  
  
  METHODS
  Fifteen referral endoscopy units.
  
  
  METHODS
  In total, 400 consecutive patients with naive papillae who were candidates for ERCP were enrolled and randomized.
  
  
  METHODS
  Patients were assigned to 4 groups according to combined catheter (S or catheter [C]) and method (with/without guidewire [GW]).
  
  
  METHODS
  Success rate of SBDC performed in 10 minutes, SBDC time, fluoroscopy time, and incidence of complications.
  
  
  RESULTS
  There was no significant difference in the SBDC success rate between the groups with and without GW, between C and S, or among the 4 groups (C+GW, C, S+GW, S). WGC had a tendency to significantly shorten cannulation and fluoroscopy times only in approximately 70% of patients in this study in whom SBDC was achieved in 10 minutes or less (P = .036 and .00004, respectively). All 4 groups resulted in similar outcomes in PEP (4%, 5.9%, 2%, and 2.1%, respectively).
  
  
  CONCLUSIONS
  Non-double-blind study.
  
  
  CONCLUSIONS
  WGC appears to significantly shorten cannulation and fluoroscopy times. However, neither the method nor type of catheter used resulted in significant differences in either SBDC success rate or incidence of PEP in this RCT. (
  
  
  BACKGROUND
  UMIN000002572.).
authors.affiliation: Department of Gastroenterology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kawakami
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Maguchi
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Mukai
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Hayashi
authors.forename: Tamito
authors.initials: T
authors.lastname: Sasaki
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Isayama
authors.forename: Yousuke
authors.initials: Y
authors.lastname: Nakai
authors.forename: Ichiro
authors.initials: I
authors.lastname: Yasuda
authors.forename: Atsushi
authors.initials: A
authors.lastname: Irisawa
authors.forename: Teitetsu
authors.initials: T
authors.lastname: Niido
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Okabe
authors.forename: Shomei
authors.initials: S
authors.lastname: Ryozawa
authors.forename: Takao
authors.initials: T
authors.lastname: Itoi
authors.forename: Keiji
authors.initials: K
authors.lastname: Hanada
authors.forename: Masataka
authors.initials: M
authors.lastname: Kikuyama
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Arisaka
authors.forename: Shogo
authors.initials: S
authors.lastname: Kikuchi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001652:Bile Ducts; D001660:Biliary Tract Diseases / Q000175:diagnosis; D002404:Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D002760:Cholangiopancreatography, Endoscopic Retrograde; D002983:Clinical Competence; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010182:Pancreatic Diseases / Q000175:diagnosis; D016717:Sphincterotomy, Endoscopic / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D013997:Time Factors