title: Endoscopic sphincterotomy associated cholangitis in patients receiving proximal biliary self-expanding metal stents.
abstract: BACKGROUND
  Endoscopic biliary stent placement during the procedure of endoscopic retrograde cholangiopancreatography (ERCP) is preferred to provide biliary drainage for unresectable malignant biliary obstruction. There is considerable controversy over the use of endoscopic sphincterotomy (ES) prior to stent placement. This study aimed to determine whether ES before intraductal self-expanding metal stent (SEMS) placement affects the clinical outcome and complications in patients with proximal malignant obstructive biliary diseases.
  
  
  METHODS
  In a prospective randomized controlled trial, 82 patients with inoperable malignant biliary strictures were randomly assigned to biliary stenting groups with or without ES. Resolution of jaundice and the incidence of complications including acute cholangitis, pancreatitis and stent occlusion within 6 months were evaluated.
  
  
  RESULTS
  SEMSs were successfully deployed in all patients, resulting in clinical and biochemical improvement of obstructive symptoms in both groups. The incidence of cholangitis was higher in the ES group than in the non-ES group (58.5% vs 31.7%, P=0.015). The interval between stent placement and the first acute cholangitis was much shorter in the ES group than in the non-ES group (P=0.024). The use of ES increased the incidence of cholangitis (P=0.004, risk ratio, 8.196). The rate of post-ERCP pancreatitis after stent placement was greater in the non-ES group than in the ES group (31.7% vs 9.8%, P=0.014). No significant differences were found in the rate of restenosis and the mortality rate between the two groups.
  
  
  CONCLUSIONS
  ES prior to intraductal SEMS placement was associated with an increased incidence of acute cholangitis. ES should be carefully evaluated prior to its use in patients with proximal malignant obstructive biliary diseases.
authors.affiliation: Department of Gastroenterology, Shanghai First People's Hospital, Shanghai Jiaotong University, Shanghai 200080, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Zhou
authors.forename: Lei
authors.initials: L
authors.lastname: Li
authors.forename: Feng
authors.initials: F
authors.lastname: Zhu
authors.forename: Sheng-Zheng
authors.initials: SZ
authors.lastname: Luo
authors.forename: Xiao-Bo
authors.initials: XB
authors.lastname: Cai
authors.forename: Xin-Jian
authors.initials: XJ
authors.lastname: Wan
mesh_terms: D000368:Aged; D002277:Carcinoma / Q000150:complications*; D002760:Cholangiopancreatography, Endoscopic Retrograde; D002761:Cholangitis / Q000209:etiology*; D002779:Cholestasis / Q000209:etiology / Q000601:surgery*; D004067:Digestive System Neoplasms / Q000150:complications*; D004322:Drainage; D005260:Female; D006801:Humans; D041781:Jaundice, Obstructive / Q000209:etiology / Q000601:surgery*; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010195:Pancreatitis / Q000209:etiology; D016717:Sphincterotomy, Endoscopic / Q000009:adverse effects*; D015607:Stents; D013997:Time Factors