title: Comparison between loop-tip guidewire-assisted and conventional endoscopic cannulation in high risk patients.
abstract: BACKGROUND
  The guidewire biliary cannulation (GWC) technique may increase the cannulation rate and decrease the risk for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. The aim of our multicenter prospective randomized controlled trial was to determine if the use of an atraumatic loop-tip guidewire reduces the rate of post-ERCP pancreatitis (PEP) compared with the standard contrast-assisted cannulation (CC) technique.
  
  
  METHODS
  From June 2012 to December 2013, a total of 320 patients who had a naïve papilla and were referred for ERCP were randomly assigned to the GWC group (n = 160) or the CC group (n = 160). GWC or CC was randomly used. In cases of failed cannulation in both arms after crossover, biliary access was attempted with alternative techniques (e. g., dual-wire technique, pancreatic duct stenting, precut).
  
  
  RESULTS
  The biliary cannulation rates were 81 % in the GWC group and 73 % in the CC group (P = n. s.). Following crossover, cannulation was successful in 8 % and 11 % of patients in the GWC and CC groups, respectively. With use of an alternative technique, the cannulation rates were 98 % in the GWC group and 96 % in the CC group, respectively. The rates of PEP were 5 % in the GWC group and 12 % in the CC group (P = 0.027). The post-interventional complication rates did not differ between the two groups.
  
  
  CONCLUSIONS
  GWC with the new wire guide is associated with a lower rate of PEP in comparison with the CC technique. Clinical trial reference number: NCT01771419.
authors.affiliation: Gastrointestinal Endoscopy Unit, San Paolo University Hospital, University of Milan, Milan, Italy.
authors.forename: Enzo
authors.initials: E
authors.lastname: Masci
authors.affiliation: Gastrointestinal Endoscopy Unit, San Paolo University Hospital, University of Milan, Milan, Italy.
authors.forename: Benedetto
authors.initials: B
authors.lastname: Mangiavillano
authors.affiliation: Unit of Gastroenterology and Digestive Endoscopy, ARNAS Garibaldi, Catania, Italy.
authors.forename: Carmelo
authors.initials: C
authors.lastname: Luigiano
authors.affiliation: Gastrointestinal Endoscopy Unit, San Paolo University Hospital, University of Milan, Milan, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Bizzotto
authors.affiliation: Digestive Endoscopy Unit, Hospital of Busto Arsizio, Busto Arsizio, Varese, Italy.
authors.forename: Eugenio
authors.initials: E
authors.lastname: Limido
authors.affiliation: Gastroenterology Department, University of Milan, IRCCS Fondazione Policlinico, Milan, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Cantù
authors.affiliation: Unit of Digestive Endoscopy, University Hospital L. Sacco, Milan, Italy.
authors.forename: Gianpiero
authors.initials: G
authors.lastname: Manes
authors.affiliation: Gastrointestinal Endoscopy Unit, San Paolo University Hospital, University of Milan, Milan, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Viaggi
authors.affiliation: Gastroenterology Unit, Valduce Hospital, Como, Italy.
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Spinzi
authors.affiliation: Gastroenterology Unit, Valduce Hospital, Como, Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Radaelli
authors.affiliation: Division of Gastroenterology and Gastrointestinal Endoscopy, Vita-Salute San Raffaele University, Scientific Institute San Raffaele, Milan, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Mariani
authors.affiliation: Unit of Gastroenterology and Digestive Endoscopy, ARNAS Garibaldi, Catania, Italy.
authors.forename: Clara
authors.initials: C
authors.lastname: Virgilio
authors.affiliation: Department of Statistics, University of Messina, Messina, Italy.
authors.forename: Angela
authors.initials: A
authors.lastname: Alibrandi
authors.affiliation: Division of Gastroenterology and Gastrointestinal Endoscopy, Vita-Salute San Raffaele University, Scientific Institute San Raffaele, Milan, Italy.
authors.forename: Pier Alberto
authors.initials: PA
authors.lastname: Testoni