title: Early precut sphincterotomy for difficult biliary access to reduce post-ERCP pancreatitis: a randomized trial.
abstract: OBJECTIVE
  Precut sphincterotomy is a technique usually employed for difficult biliary cannulation during endoscopic retrograde cholangiopancreatography (ERCP) for the treatment of bile duct disease. It is a validated risk factor for post-ERCP pancreatitis (PEP), but it is not clear whether the risk is related to the technique itself or to the repeated biliary cannulation attempts preceding it. The primary aim of the study was to assess the incidence of PEP in early precut compared with the standard technique in patients with difficult biliary cannulation. Secondary aims were to compare complications and cannulation success.
  
  
  METHODS
  In this prospective, multicenter, randomized, clinical trial, patients who were referred for therapeutic biliary ERCP and difficult biliary cannulation were randomized to early precut (Group A) or repeated papillary cannulation attempts followed, in cases of failure, by late precut (Group B). PEP was defined as the onset of upper abdominal pain associated with an elevation in serum pancreatic enzymes of at least three times the normal level at more than 24 hours after the procedure. No rectal indomethacin or diclofenac was used for prevention of PEP.
  
  
  RESULTS
  A total of 375 patients were enrolled. PEP developed in 10 of the 185 patients (5.4 %) in Group A and 23 of the 190 (12.1 %) in Group B (odds ratio [OR] 0.35; 95 % confidence interval [CI] 0.16 - 0.78). The incidence of PEP was significantly lower in the early precut group (10/185, 5.4 %) than in the delayed precut subgroup (19/135 [14.1 %]; OR 0.42, 95 %CI 0.17 - 1.07). There were no differences in biliary cannulation success rates, bleeding, perforation, and cholangitis.
  
  
  CONCLUSIONS
  In patients with difficult biliary cannulation, early precut is an effective technique and can significantly reduce the incidence of PEP. Repeated biliary cannulation attempts are a real risk factor for this complication.
authors.affiliation: Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, Scientific Institute San Raffaele Milan, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Mariani
authors.affiliation: Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, Scientific Institute San Raffaele Milan, Italy.
authors.forename: Milena
authors.initials: M
authors.lastname: Di Leo
authors.affiliation: Gastroenterology and Gastrointestinal Endoscopy Unit, S.G. Moscati Hospital, Avellino, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Giardullo
authors.affiliation: Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, Scientific Institute San Raffaele Milan, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Giussani
authors.affiliation: Gastroenterology Unit, A.O.U.S. Policlinico S.Maria alle Scotte, Siena, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Marini
authors.affiliation: Digestive Endoscopy and Gastroenterology Unit, A.O. Istituti Ospitalieri di Cremona, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Buffoli
authors.affiliation: Gastroenterology, Maresca Hospital, Torre del Greco, Italy.
authors.forename: Livio
authors.initials: L
authors.lastname: Cipolletta
authors.affiliation: Division of Gastroenterology, Valduce Hospital, Como, Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Radaelli
authors.affiliation: Digestive Endoscopy Unit, Department of Gastroenterology, Papa Giovanni XXIII Hospital, Bergamo, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Ravelli
authors.affiliation: Digestive Endoscopy Unit, A. Cardarelli Hospital, Napoli, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Lombardi
authors.affiliation: Gastroenterology and Gastrointestinal Endoscopy Unit, S.G. Moscati Hospital, Avellino, Italy.
authors.forename: Vittorio
authors.initials: V
authors.lastname: D'Onofrio
authors.affiliation: Gastroenterology Unit, A.O.U.S. Policlinico S.Maria alle Scotte, Siena, Italy.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Macchiarelli
authors.affiliation: Digestive Endoscopy and Gastroenterology Unit, A.O. Istituti Ospitalieri di Cremona, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Iiritano
authors.affiliation: Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, Scientific Institute San Raffaele Milan, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Le Grazie
authors.affiliation: UniSR-Social.Lab (Research Methods), San Raffaele University of Milan, Faculty of Psychology, Milan, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Pantaleo
authors.affiliation: Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, Scientific Institute San Raffaele Milan, Italy.
authors.forename: Pier Alberto
authors.initials: PA
authors.lastname: Testoni
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002404:Catheterization / Q000009:adverse effects*; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D003135:Common Bile Duct; D057239:Early Termination of Clinical Trials; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000209:etiology / Q000517:prevention & control*; D011183:Postoperative Complications / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D065840:Protective Factors; D016717:Sphincterotomy, Endoscopic / Q000379:methods*