Safety of Extension of a Previous Endoscopic Sphincterotomy: A Prospective Study Christos Mavrogiannis, M.D., Christos Liatsos, M.D., Ioannis S. Papanikolaou, M.D., Dimitris I. Psilopoulos, M.D., Spyros S. Goulas, M.D., Andreas Romanos, M.D., and Gerasimos Karvountzis, M.D. Department of Gastroenterology, Hippokration General Hospital, Athens; Academic Department of Gastroenterology, Helena Venizelou General Hospital, Faculty of Nursing, Athens University, Athens; and Surgical Endoscopy Unit, Hippokration General Hospital, Athens, Greece OBJECTIVES: Data in the literature regarding complication risks after the extension of a previous endoscopic biliary sphincterotomy (repeat endoscopic biliary sphincterotomy) are limited and controversial. To explore this issue, we prospectively studied complications after repeat sphincter- otomy and compared them with those of biliary endoscopic sphincterotomy in consecutive patients with choledocholi- thiasis. METHODS: A total of 250 patients underwent endoscopic biliary sphincterotomy and 81 underwent extension of a previous one. All patients had choledocholithiasis and were enrolled using specific criteria, excluding parameters pre- disposing to increased postsphincterotomy complications. RESULTS: The overall complication rate was 2.46% in the repeat sphincterotomy and 8.4% in the sphincterotomy group (p  0.05). Complications for the repeat sphincter- otomy and initial sphincterotomy groups, respectively, were as follows: bleeding, 2.46% and 2.8%; pancreatitis, 0% and 4.8% (p  0.05); cholangitis, 0% and 0.4%; perforation, 0% and 0.4%; and hyperamylasemia, 3.7% and 12.8% (p  0.05). There were no deaths. Bleeding episodes in the former group occurred when repeat sphincterotomy was performed early after the primary one. CONCLUSIONS: Repeat sphincterotomy is a safe technique for the treatment of patients with choledocholithiasis and seems to be as safe as initial sphincterotomy. It is not associated with increased hemorrhage risk. There is a trend toward a higher risk of hemorrhage when repeat sphincter- otomy is performed early. Repeat sphincterotomy is safer than the initial sphincterotomy with respect to pancreatic complications. (Am J Gastroenterol 2003;98:72–76. © 2003 by Am. Coll. of Gastroenterology) INTRODUCTION Endoscopic biliary sphincterotomy (EBS) is a technique commonly used for the treatment of several biliary and pancreatic disorders. The frequency of complications occur- ring after EBS varies widely and is primarily related to the indication for the procedure and to the endoscopic technique (1). Post-EBS hemorrhage is one of the most common and severe complications, occurring in 2–11% of patients (1–3). Pancreatitis, after ERCP and endoscopic sphincterotomy, is another severe complication, occurring in 1.3–5.4% of pa- tients (1, 4, 5). It consists of a clinical syndrome of abdom- inal pain and hyperamylasemia. Asymptomatic hyperamy- lasemia on the other hand, has been reported in as much as 75% of patients undergoing ERCP (6, 7). The risk of per- foration is about 1% in most studies (8, 9), with a higher incidence observed in patients with nondilated bile ducts (10). The risk of postendoscopic cholangitis and cholecys- titis in patients referred for EBS may reach 2.2% (3, 8). The aim of our prospective study was to evaluate the safety of the extension of a previously performed endo- scopic sphincterotomy (repeat endoscopic biliary sphincter- otomy [R-EBS]) in a group of consecutive patients, by estimating complications that occurred within a period of 1–9 days after the procedure. Because of the limited and controversial data regarding the risk of hemorrhage after the extension of a previous EBS, and because of the expected lower rate of acute pancreatitis after R-EBS, we attempted to assess the rate of those hazardous complications. The study population included patients exclusively with chole- docholithiasis, as these patients are a homogeneous group and are usually in need of R-EBS, in view of sphincterot- omy stenosis and bile duct stone recurrence. MATERIALS AND METHODS Between February, 1994, and February, 1998, a total of 112 consecutive patients underwent ERCP for suspected recur- rent or inadequately treated choledocholithiasis, based on clinical and laboratory data as well as imaging studies. Among them, 81 underwent extension of a previously per- formed (1 day to 7 yr previously) EBS and were included in this study, according to specific enrollment criteria. Of these patients, 66 underwent a late extension (defined as an ex- tension performed within a period of 9 days to 7 yr after the THE AMERICAN JOURNAL OF GASTROENTEROLOGY Vol. 98, No. 1, 2003 © 2003 by Am. Coll. of Gastroenterology ISSN 0002-9270/03/$30.00 Published by Elsevier Science Inc. PII S0002-9270(02)05834-3