title: A novel, stiff-shaft, flexible-tip guidewire for cannulation of biliary stricture during endoscopic retrograde cholangiopancreatography: a randomized trial.
abstract: OBJECTIVE
  During endoscopic retrograde cholangiopancreatography (ERCP), a guidewire is used to cannulate biliary strictures and allow for therapeutic interventions. The aim of this study was to assess the success of stricture cannulation using a combination of a flexible guidewire and a stable nitinol wire vs. a novel, single, stiff-shaft, flexible-tip guidewire.
  
  
  METHODS
  Consecutive patients who were scheduled for ERCP for biliary obstruction were randomized to undergo the procedure with either a 260-cm long, angled-tip hydrophilic wire in combination with a nitinol wire as required (standard group), or a novel, 270-cm guidewire featuring a hyperflexible, hydrophilic tip with a stiff shaft (novel group). At unsuccessful negotiation of the stricture, patients in the standard group were switched to the novel guidewire and vice versa ("crossover"). Successful cannulation (primary success: as assigned; final success: after "crossover"), procedure time, and total number of wires needed per procedure were compared.
  
  
  RESULTS
  A total of 222 patients were randomized and 197 were included in the study (97 in the standard group and 100 in the novel group). The primary success rate was significantly higher in the novel group (94/100, 94 %) compared with the standard group (77/97, 79 %; P = 0.00041), and final success was similar. Mean time (median, interquartile range) to stricture cannulation was 11.2 minutes (6.3, 3.7 - 14.6) in the standard group and 8.1 minutes (2.5, 0.9 - 7.7) in the novel group (P < 0.0001). The mean total procedure time was 31.2 minutes (24.6, 16.5 - 40.8) vs. 24.3 minutes (16.9, 10.0 - 31.5), respectively (P = 0.0011). There were no complications observed with either of the guidewires.
  
  
  CONCLUSIONS
  A guidewire that features a flexible tip with a stable shaft could replace the use of a combination of flexible and stable guidewires and increase the success rate of stricture cannulation while decreasing the procedure time.ClinicalTrials.gov Identifier: NCT 01382680.
authors.affiliation: Department of Medicine 1, J. W. Goethe University Hospital, Frankfurt, Germany.
authors.forename: Jörg G
authors.initials: JG
authors.lastname: Albert
authors.affiliation: Department of Medicine 1, J. W. Goethe University Hospital, Frankfurt, Germany.
authors.forename: Katja
authors.initials: K
authors.lastname: Lucas
authors.affiliation: Institute of Biostatistics and Math Modeling, Faculty of Medicine, J. W. Goethe University, Frankfurt, Germany.
authors.forename: Natalie
authors.initials: N
authors.lastname: Filmann
authors.affiliation: Institute of Biostatistics and Math Modeling, Faculty of Medicine, J. W. Goethe University, Frankfurt, Germany.
authors.forename: Eva
authors.initials: E
authors.lastname: Herrmann
authors.affiliation: Department of Medicine 1, J. W. Goethe University Hospital, Frankfurt, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Schröder
authors.affiliation: Department of Medicine 1, J. W. Goethe University Hospital, Frankfurt, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Sarrazin
authors.affiliation: Department of Medicine 1, J. W. Goethe University Hospital, Frankfurt, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Trojan
authors.affiliation: Department of Medicine 1, J. W. Goethe University Hospital, Frankfurt, Germany.
authors.forename: Bernd
authors.initials: B
authors.lastname: Kronenberger
authors.affiliation: Department of Medicine 1, J. W. Goethe University Hospital, Frankfurt, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Bojunga
authors.affiliation: Department of Medicine 1, J. W. Goethe University Hospital, Frankfurt, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Zeuzem
authors.affiliation: Department of Medicine 1, J. W. Goethe University Hospital, Frankfurt, Germany.
authors.forename: Mireen
authors.initials: M
authors.lastname: Friedrich-Rust
mesh_terms: D000328:Adult; D000368:Aged; D001652:Bile Ducts / Q000473:pathology*; D002404:Catheterization / Q000295:instrumentation*; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000295:instrumentation*; D002769:Cholelithiasis / Q000150:complications; D003251:Constriction, Pathologic / Q000209:etiology / Q000628:therapy; D018592:Cross-Over Studies; D004067:Digestive System Neoplasms / Q000150:complications*; D005260:Female; D006801:Humans; D007249:Inflammation / Q000150:complications; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D016037:Single-Blind Method; D013525:Surgical Instruments / Q000706:statistics & numerical data