Routine biliary sphincterotomy may not be indispensible for endoscopic pancreatic sphincterotomy

Background/Aims: It is generally accepted that biliary sphincterotomy is mandatory to avoid possible cholangitis due to edema after pancreatic sphincterotomy. However, the above claim has not been proven by prospective randomized study. The aim of our study is to determine whether cholangitis develops more frequently when the patients have not undergone concomitant biliary sphincterotomy during the endoscopic pancreatic sphincterotomy. Methods: Sixty patients with non-alcoholic chronic calcifying pancreatitis were enrolled. The patients with jaundice (bilirubin ≥3 mg/dl), cholangitis, or parenchymal liver disease were excluded. The patients were randomly assigned either to dual sphincterotomy (group I: n = 30) or to pancreatic sphincterotomy alone (group II: n = 30). Group I & II were further classified as IA (or IIA) and IB (or IIB), according to the level of serum alkaline phosphatase (sALP) and the diameter of common bile duct (CBD); that is, group IA (or IIA) when abnormal in both sALP (≥2 times the upper limit of normal value) and CBD (≥12mm), whereas group IB (or IIB) when normal or solely abnormal in sALP and CBD. Results: Dual sphincterotomy Panc. sphincterotomy alone IA (n=8) IB (n=22) IIA (n=9) IIB (n=21) Cholangitis 0 1 (4.5) 5 (55.6) * 0 Hemorrhage 0 1 (4.5) 0 1 (4.8) Pancreatitis 1 (12.5) 0 0 1(4.8) ( ) indicates percents, * Significantly more frequent than other groups (p<0.05). Conclusions: Our results suggest that dual sphincterotomy may be indicated only in patients who have both dilated CBD and elevated sALP.