RANDOMIZED TRIAL OF ENDOSCOPIC BALLOON DILATION VERSUS ENDOSCOPIC SPHINCTEROTOMY FOR REMOVAL OF BILEDUCT STONES

Background Endoscopic sphincterotomy (EST) for the removal of bileduct stones is associated with acute complications and a permanent loss of biliary-sphincter function. Endoscopic balloon dilation (EBD) causes less trauma to the biliary sphincter, but may be less effective in all owing stone removal. Methods 218 consecutive patients with bileduct st ones on endoscopic retrograde cholangiopancreatography (ERCP) were enr olled. 202 who met all eligibility criteria were randomly assigned EST or EBD. The patients were observed in hospital for at least 24 h and followed up at 1 month and 6 months. Complications were classified by an expert panel unaware of treatment allocation and outcome. Analysis was done by intention to treat. Findings After a single ERCP, all ston es were removed from 92 (91%) of 101 patients assigned EST and 90 (89% ) of 101 assigned EBD (p=0.81); in nine of the latter, successful remo val required additional EST. Mechanical lithotripsy was used to fragme nt stones in 31 EBD procedures and 13 EST procedures (p<0.005). Early complications (before 15 days) occurred in 24 EST patients and 17 EBD patients (p=0.29). One patient died of retroperitoneal perforation aft er EBD. Four patients had bleeding after EST. Seven patients in each g roup had pancreatitis. Complications during follow-up occurred in 23 E ST patients and 18 EBD patients (p=0.48). Acute cholecystitis was obse rved in seven EST patients and one EBD patient (p<0.05). Interpretatio n The success rate of EBD was similar to that of EST. We found there i s no evidence of the previously suggested higher risk of pancreatitis with EBD and suggest that EBD is preferred in patients at risk of blee ding after EST. Preservation of biliary-sphincter function after EBD m ay prevent long-term complications and reduce the risk of acute cholec ystitis during followup. This procedure is a valuable alternative to E ST in patients with bileduct stones.