Manometry based randomised trial of endoscopic sphincterotomy for sphincter of Oddi dysfunction

Background-Endoscopic sphincterotomy for biliary-type pain after cholecyste ctomy remains controversial despite evidence of efficacy in some patients w ith a high sphincter of Oddi (SO) basal pressure (SO stenosis). Aim-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 bili ary-type pain after cholecystectomy who had a dilated bile duct on retrogra de cholangiography, transient increases in liver enzymes after episodes of pain, or positive responses to challenge with morphine/ neostigmine. The ma nometric record was categorised as SO stenosis, SO dyskinesia, or normal, a fter which the patient was randomised in each category to sphincterotomy or to a sham procedure in a prospective double blind study. Symptoms were ass essed 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 tr eated 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. Complicati ons were rare, but included mild pancreatitis in seven patients (14 episode s) and a collection in the right upper quadrant, presumably related to a mi nor perforation. At three months, the endoscopic incision was extended in 1 9 patients because of manometric months, the endoscopic incision was metric evidence of incomplete division of the sphincter. Conclusion-In patients with presumed SO dysfunction, endoscopic sphincterot omy is helpful in those with manometric features of SO stenosis.