title: Prospective comparative study of endoscopic papillary large balloon dilation and endoscopic sphincterotomy for removal of large bile duct stones in patients above 45 years of age.
abstract: OBJECTIVE
  Although endoscopic papillary large balloon dilation (EPLBD) with limited endoscopic sphincterotomy (ES) showed excellent outcomes for treatment of large bile duct stones, hemorrhage and recurrence of stones are problematic complications. Recent studies suggest that EPLBD alone is safe and effective for removal of large bile duct stones. This study aimed to determine the therapeutic outcomes and safety of EPLBD, compared with ES, for removal of large bile duct stones.
  
  
  METHODS
  Eighty-three patients above 45 years of age with bile duct stones >1 cm in diameter were randomized to EPLBD and ES groups for removal of common bile duct stones from September 2010 to August 2011. Prophylactic gabexate mesilate was given to all patients.
  
  
  RESULTS
  Baseline characteristics were not significantly different, except diabetes and gallbladder stones between the EPLBD group (n = 40) and ES group (n = 43). The overall complete stone removal rate in each group was 97.5% (39/40) and 95.3% (41/43), respectively (p = 0.600). Requirement of mechanical lithotripsy was not significantly different between the EPLBD and ES group (10% vs. 21%, p = 0.171). Complete ductal clearance in one session was achieved in 82.4% and 81.4% of cases in each group, respectively (p = 0.577). There were no differences in complication rates between the EPLBD and ES group; pancreatitis, 5.0% vs. 7.0%; hemorrhage, 10.0% vs. 16.3%; acute cholangitis, 5.0% vs. 2.3%, and perforation, 2.5% vs. 0%.
  
  
  CONCLUSIONS
  The therapeutic outcomes and complications of EPLBD for removal of large bile duct stones are comparable to those of ES.
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
authors.forename: Myung Jin
authors.initials: MJ
authors.lastname: Oh
authors.forename: Tae Nyeun
authors.initials: TN
authors.lastname: Kim
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D014670:Ampulla of Vater / Q000601:surgery; D000925:Anticoagulants / Q000008:administration & dosage; D002404:Catheterization / Q000009:adverse effects; D016009:Chi-Square Distribution; D004106:Dilatation / Q000009:adverse effects; D005260:Female; D016670:Gabexate / Q000008:administration & dosage; D042882:Gallstones / Q000473:pathology / Q000628:therapy*; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000209:etiology; D016717:Sphincterotomy, Endoscopic / Q000009:adverse effects; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D016670:Gabexate