title: Endoscopic sphincterotomy before deployment of covered metal stent is associated with greater complication rate: a prospective randomized control trial.
abstract: OBJECTIVE
  Endoscopic sphincterotomy (ES) may facilitate insertion of self expandable metal stent (SEMS) and also help avert the development of pancreatitis from stent-related occlusion of the pancreatic duct. On the other hand, ES is also independently associated with pancreatitis, bleeding, and perforation. We evaluated whether ES before SEMS placement was associated with a greater likelihood of stent migration and other complications in patients with malignant obstruction of the distal common bile duct.
  
  
  METHODS
  Seventy-four patients with unresectable distal bile duct obstruction were prospectively randomized to biliary stenting following ES (group 1) and without ES (group 2). Main outcome measures included overall procedure complications rates including stent migration, stent occlusion, oxygen desaturation, bleeding, perforation, and pancreatitis.
  
  
  RESULTS
  Covered SEMS were successfully deployed in all patients in both groups. Stent migration occurred in 6 patients (16%) in group 1 and 1 patient (3%) in group 2, P=0.075. Overall, complications occurred in 18 patients in group 1 and 4 patients in group 2, P=0.006. There was no pancreatitis in either group.
  
  
  CONCLUSIONS
  Deployment of covered SEMS without prior ES in patients with distal common bile duct obstruction owing to pancreatic cancer is feasible and prevents the development of complications such as stent migration, bleeding, and perforation.
authors.affiliation: Stony Brook University and Northport VA Medical Center, Northport, NY 11790, USA.
authors.forename: Everson L A
authors.initials: EL
authors.lastname: Artifon
authors.forename: Paulo
authors.initials: P
authors.lastname: Sakai
authors.forename: Shinichi
authors.initials: S
authors.lastname: Ishioka
authors.forename: Sérgio B
authors.initials: SB
authors.lastname: Marques
authors.forename: André S
authors.initials: AS
authors.lastname: Lino
authors.forename: José E M
authors.initials: JE
authors.lastname: Cunha
authors.forename: José
authors.initials: J
authors.lastname: Jukemura
authors.forename: Ivan
authors.initials: I
authors.lastname: Cecconello
authors.forename: Flair J
authors.initials: FJ
authors.lastname: Carrilho
authors.forename: Eduardo
authors.initials: E
authors.lastname: Opitz
authors.forename: Atul
authors.initials: A
authors.lastname: Kumar
mesh_terms: D000230:Adenocarcinoma / Q000150:complications*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002779:Cholestasis / Q000209:etiology / Q000601:surgery*; D003135:Common Bile Duct / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000150:complications*; D011446:Prospective Studies; D016717:Sphincterotomy, Endoscopic / Q000009:adverse effects*; D015607:Stents / Q000009:adverse effects* / Q000706:statistics & numerical data; D016896:Treatment Outcome