title: Pre-cut papillotomy with a new papillotome.
abstract: BACKGROUND
  A new papillotome has been developed, an isolated-tip needle-knife papillotome (Iso-Tome) that has a semi-oval-shaped tip of epoxide adhesive to prevent electric leakage from the tip of the incising needle. The coated tip aids in keeping the papillotome tightly in the orifice of the ampulla of Vater and is believed to prevent unintentional deep cuts or perforations. This study was done to evaluate the clinical usefulness of the new papillotome for pre-cut papillotomy.
  
  
  METHODS
  From June 2003 to November 2003, 115 patients underwent attempted ERCP. If biliary cannulation failed by the conventional method, pre-cut papillotomy was performed by using the Iso-Tome in the direction of the bile duct. After successful bile-duct cannulation, papillotomy was extended for therapeutic procedures, such as stone removal or stent insertion, in the majority of the cases. Post-ERCP complications were classified according to consensus guidelines.
  
  
  METHODS
  Pre-cut papillotomy with the Iso-Tome was done in 25 patients (21.7% of cases). Protective pancreatic stents were not used. Of these patients, 11 had common bile duct stones, 7 had pancreatitis, 5 had malignancies, one had sphincter of Oddi dysfunction, and one had bile-duct leak. After pre-cut papillotomy with the Iso-Tome, bile-duct cannulation was successfully achieved in 23 of 25 (92%) patients. Complications occurred in 7 of 25 patients (28%) and consisted of mild pancreatitis in 5 (20%), moderate bleeding in one (4%), and biliary pain in one (4%). All 7 patients with complications were managed medically, and there was no death.
  
  
  CONCLUSIONS
  In this pilot study, the isolated-tip needle knife was found to be a clinically useful papillotome for pre-cut papillotomy. Further large comparative studies (with and without pancreatic protective stents) are needed to determine improved efficacy and safety compared with standard techniques.
authors.affiliation: Division of Gastroenterology and Clinical Research Institute, Soon Chun Hyang University Cheonan Hospital, Cheonan, Korea.
authors.forename: Sang-Heum
authors.initials: SH
authors.lastname: Park
authors.forename: Hyun-Jun
authors.initials: HJ
authors.lastname: Kim
authors.forename: Do Hyun
authors.initials: DH
authors.lastname: Park
authors.forename: Jung-Hoon
authors.initials: JH
authors.lastname: Kim
authors.forename: Jae-Hak
authors.initials: JH
authors.lastname: Lee
authors.forename: Suck-Ho
authors.initials: SH
authors.lastname: Lee
authors.forename: Il-Kwun
authors.initials: IK
authors.lastname: Chung
authors.forename: Hong-Soo
authors.initials: HS
authors.lastname: Kim
authors.forename: Sun-Joo
authors.initials: SJ
authors.lastname: Kim
mesh_terms: D014670:Ampulla of Vater / Q000601:surgery*; D003137:Common Bile Duct Diseases / Q000601:surgery*; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010182:Pancreatic Diseases / Q000601:surgery*; D012189:Retrospective Studies; D016717:Sphincterotomy, Endoscopic / Q000295:instrumentation*