title: Randomized Trial of Endoscopist-Controlled vs. Assistant-Controlled Wire-Guided Cannulation of the Bile Duct.
abstract: OBJECTIVE
  Biliary cannulation is frequently the most difficult component of endoscopic retrograde cholangiopancreatography (ERCP). Techniques employed to improve safety and efficacy include wire-guided access and the use of sphincterotomes. However, a variety of options for these techniques are available and optimum strategies are not defined. We assessed whether the use of endoscopist- vs. assistant-controlled wire guidance and small vs. standard-diameter sphincterotomes improves safety and/or efficacy of bile duct cannulation.
  
  
  METHODS
  Patients were randomized using a 2 × 2 factorial design to initial cannulation attempt with endoscopist- vs. assistant-controlled wire systems (1:1 ratio) and small (3.9Fr tip) vs. standard (4.4Fr tip) sphincterotomes (1:1 ratio). The primary efficacy outcome was successful deep bile duct cannulation within 8 attempts. Sample size of 498 was planned to demonstrate a significant increase in cannulation of 10%. Interim analysis was planned after 200 patients-with a stopping rule pre-defined for a significant difference in the composite safety end point (pancreatitis, cholangitis, bleeding, and perforation).
  
  
  RESULTS
  The study was stopped after the interim analysis, with 216 patients randomized, due to a significant difference in the safety end point with endoscopist- vs. assistant-controlled wire guidance (3/109 (2.8%) vs. 12/107 (11.2%), P=0.016), primarily due to a lower rate of post-ERCP pancreatitis (3/109 (2.8%) vs. 10/107 (9.3%), P=0.049). The difference in successful biliary cannulation for endoscopist- vs. assistant-controlled wire guidance was -0.5% (95% CI-12.0 to 11.1%) and for small vs. standard sphincerotome -0.9% (95% CI-12.5 to 10.6%).
  
  
  CONCLUSIONS
  Use of the endoscopist- rather than assistant-controlled wire guidance for bile duct cannulation reduces complications of ERCP such as pancreatitis.
authors.affiliation: Division of Gastroenterology and Liver Diseases, University of Southern California, Keck School of Medicine, Los Angeles, California, USA.
authors.forename: James
authors.initials: J
authors.lastname: Buxbaum
authors.affiliation: Division of Gastroenterology and Liver Diseases, University of Southern California, Keck School of Medicine, Los Angeles, California, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Leonor
authors.affiliation: Division of Gastroenterology and Liver Diseases, University of Southern California, Keck School of Medicine, Los Angeles, California, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Tung
authors.affiliation: Division of Gastroenterology and Liver Diseases, University of Southern California, Keck School of Medicine, Los Angeles, California, USA.
authors.forename: Christianne
authors.initials: C
authors.lastname: Lane
authors.affiliation: Division of Gastroenterology and Liver Diseases, University of Southern California, Keck School of Medicine, Los Angeles, California, USA.
authors.forename: Ara
authors.initials: A
authors.lastname: Sahakian
authors.affiliation: Yale School of Medicine, New Haven, CT and VA Connecticut Healthcare System, West Haven, Connecticut, USA.
authors.forename: Loren
authors.initials: L
authors.lastname: Laine
mesh_terms: D000328:Adult; D001652:Bile Ducts / Q000293:injuries* / Q000601:surgery; D002404:Catheterization / Q000009:adverse effects / Q000379:methods*; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects / Q000379:methods*; D002761:Cholangitis / Q000453:epidemiology / Q000209:etiology; D057239:Early Termination of Clinical Trials; D005260:Female; D000072102:Gastroenterologists; D006470:Hemorrhage / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D007431:Intraoperative Complications / Q000453:epidemiology* / Q000209:etiology; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009726:Nurses; D010195:Pancreatitis / Q000453:epidemiology / Q000209:etiology; D061214:Patient Safety; D011183:Postoperative Complications / Q000453:epidemiology* / Q000209:etiology; D019106:Postoperative Hemorrhage / Q000453:epidemiology / Q000209:etiology