title: Manometry based randomised trial of endoscopic sphincterotomy for sphincter of Oddi dysfunction.
abstract: BACKGROUND
  Endoscopic sphincterotomy for biliary-type pain after cholecystectomy remains controversial despite evidence of efficacy in some patients with a high sphincter of Oddi (SO) basal pressure (SO stenosis).
  
  
  OBJECTIVE
  To evaluate the effects of sphincterotomy in patients randomised on the basis of results from endoscopic biliary manometry.
  
  
  METHODS
  Endoscopic biliary manometry was performed in 81 patients with biliary-type pain after cholecystectomy who had a dilated bile duct on retrograde cholangiography, transient increases in liver enzymes after episodes of pain, or positive responses to challenge with morphine/neostigmine. The manometric record was categorised as SO stenosis, SO dyskinesia, or normal, after which the patient was randomised in each category to sphincterotomy or to a sham procedure in a prospective double blind study. Symptoms were assessed at intervals of three months for 24 months by an independent observer, and the effects of sphincterotomy on sphincter function were monitored by repeat manometry after three and 24 months.
  
  
  RESULTS
  In the SO stenosis group, symptoms improved in 11 of 13 patients treated by sphincterotomy and in five of 13 subjected to a sham procedure (p = 0.041). When manometric records were categorised as dyskinesia or normal, results from sphincterotomy and sham procedures did not differ. Complications were rare, but included mild pancreatitis in seven patients (14 episodes) and a collection in the right upper quadrant, presumably related to a minor perforation. At three months, the endoscopic incision was extended in 19 patients because of manometric evidence of incomplete division of the sphincter.
  
  
  CONCLUSIONS
  In patients with presumed SO dysfunction, endoscopic sphincterotomy is helpful in those with manometric features of SO stenosis.
authors.affiliation: GI Surgical Unit, Flinders Medical Centre, Adelaide, Australia.
authors.forename: J
authors.initials: J
authors.lastname: Toouli
authors.forename: I C
authors.initials: IC
authors.lastname: Roberts-Thomson
authors.forename: J
authors.initials: J
authors.lastname: Kellow
authors.forename: J
authors.initials: J
authors.lastname: Dowsett
authors.forename: G T
authors.initials: GT
authors.lastname: Saccone
authors.forename: P
authors.initials: P
authors.lastname: Evans
authors.forename: P
authors.initials: P
authors.lastname: Jeans
authors.forename: M
authors.initials: M
authors.lastname: Cox
authors.forename: P
authors.initials: P
authors.lastname: Anderson
authors.forename: C
authors.initials: C
authors.lastname: Worthley
authors.forename: Y
authors.initials: Y
authors.lastname: Chan
authors.forename: N
authors.initials: N
authors.lastname: Shanks
authors.forename: A
authors.initials: A
authors.lastname: Craig
mesh_terms: D000328:Adult; D000368:Aged; D002763:Cholecystectomy; D003137:Common Bile Duct Diseases / Q000175:diagnosis / Q000601:surgery*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008365:Manometry; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D009803:Sphincter of Oddi / Q000601:surgery*; D016717:Sphincterotomy, Endoscopic