Endoscopic balloon sphincteroplasty as an adjunct to endoscopic sphincterotomy in removing large and difficult bile duct stones

To evaluate the effectiveness of endoscopic balloon sphincteroplasty as an adjunct to endoscopic sphincterotomy in removing large and difficult bile duct stones. A prospective non-randomized descriptive study was conducted at the Endoscopic Service of Surgical Unit 4, Civil Hospital Karachi over a period of 2 years from February 2007 to January 2009. A total of 84 patients where the biliary calculus was either greater than 15mm or difficult to remove with standard techniques underwent ERCP with endoscopic sphincterotomy and balloon sphincteroplasty. Patients with diagnosis of cholangitis or "pancreatitis were excluded from the study. Endoscopic balloon dilatation was performed after standard sphincterotomy by using standard 15-18mm Controlled Radial Expansion [CRE] balloons. All procedures were done as day case under conscious sedation. There were 18 [21.4%] male and 66 [78.6%] females. Age of the study population ranged from 16-85 years with a mean of 48.38 +/- 17.07 years. The size of the stone ranged from 10-32mm with a mean of 14.7 +/- 0.44mm. Stones were removed with sphincteroplasty in first session in 52/84 [61.9%] patients, 11/17 [64.4%] patients in the second session and 4/4 [100%] in the third session. Patients who were lost to follow up were 14[16.7%]. Surgery was advised for 2 [2.4%] patients because of failure to remove stones by sphincteroplasty. Overall success of endoscopic sphincterotomy and large balloon dilatation in our study was 79.76%. Complications were seen in seven patients [8.3%] while one [1.2%] died. Bleeding was encountered in 3 [3.6%] patients which was controlled by adrenaline injection in 2 patients while one patient died due to severe haemorrhage before any surgical intervention could be undertaken. Moderate pancreatitis necessitating admission was seen in 3 patients [3.6%]. None of the patients had severe pancreatitis or perforation secondary to the procedure. Large balloon dilatation along with endoscopic sphincterotomy is a simple, safe and effective technique in removing large bile duct stones, in patients with distal common bile duct narrowing or in whom the size of stone is greater than the size of common bile duct with a complication rate if not less equal to that of endoscopic sphincterotomy alone