title: Precut papillotomy versus persistence in difficult biliary cannulation: a prospective randomized trial.
abstract: OBJECTIVE
  Failed biliary cannulation occurs in up to 10% of patients undergoing ERCP. There is some controversy as to the safety and efficacy of using precut techniques to achieve biliary cannulation in difficult cases. To date, no randomized trial has compared the success and complication rates of precut with the rates for persistence when biliary cannulation is difficult. The aim of this study was to compare the success rates and complication rates of precut with the success rates and complication rates of persistence in cases of difficult biliary cannulation.
  
  
  METHODS
  Patients without prior sphincterotomy who required biliary cannulation were screened. A "difficult biliary cannulation" was arbitrarily defined as failed cannulation after 12 minutes. These patients were then randomized to continue treatment by needle-knife cut over the roof of the papilla or by persistence with a non-wire-guided, single-lumen papillotome. "Primary" success was defined as deep cannulation within 15 minutes of randomization. Primary and final success rates and complication rates within 30 days after ERCP were compared.
  
  
  RESULTS
  Over a 38-month period a total of 642 patients were screened. Patients in whom biliary cannulation was successful within a time period of 12 minutes or less formed the reference group (n = 580). The remainder of the patients were randomly assigned to the "precut" arm (n = 32) or to the "persistence" arm (n = 30). Primary success rates and complication rates were similar in the precut and persistence arms (75% and 4% respectively for the precut arm vs. 73% and 9% for the persistence arm). The final successful cannulation rate in the entire group of 642 patients was 99.5%.
  
  
  CONCLUSIONS
  In experienced hands, precut papillotomy and persistence in cannulation are equally effective in cases of difficult cannulation, with a similar complication rate.
authors.affiliation: The Center for Advanced Therapeutic Endoscopy and Endoscopic Oncology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
authors.forename: S-J
authors.initials: SJ
authors.lastname: Tang
authors.forename: G B
authors.initials: GB
authors.lastname: Haber
authors.forename: P
authors.initials: P
authors.lastname: Kortan
authors.forename: S
authors.initials: S
authors.lastname: Zanati
authors.forename: M
authors.initials: M
authors.lastname: Cirocco
authors.forename: M
authors.initials: M
authors.lastname: Ennis
authors.forename: A
authors.initials: A
authors.lastname: Elfant
authors.forename: D
authors.initials: D
authors.lastname: Scheider
authors.forename: H
authors.initials: H
authors.lastname: Ter
authors.forename: J
authors.initials: J
authors.lastname: Dorais
mesh_terms: D015746:Abdominal Pain / Q000209:etiology*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001660:Biliary Tract Diseases / Q000601:surgery; D002404:Catheterization / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000209:etiology*; D019106:Postoperative Hemorrhage / Q000209:etiology*; D011446:Prospective Studies; D012086:Reoperation; D016717:Sphincterotomy, Endoscopic / Q000009:adverse effects* / Q000379:methods*; D016896:Treatment Outcome