Routine biliary sphincterotomy may not be indispensable for endoscopic pancreatic sphincterotomy

Background and Study Aims: It is generally accepted that biliary sphinctero tomy is mandatory to avoid possible cholestasis and infection due to edema after pancreatic sphincterotomy. However, biliary sphincterotomy is an inva sive procedure and the above claim on dual sphincterotomy has not been prov en by a prospective randomized study. The aim of our study was to determine whether cholangitis develops more frequently when the patients have not un dergone concomitant biliary sphincterotomy during the endoscopic pancreatic sphincterotomy. Patients and Methods: From January 1990 to November 1997, 60 patients (38 m en, 22 women, age range 19-45 years) with non-alcoholic chronic calcifying pancreatitis were prospectively enrolled. The patients with jaundice (bilir ubin greater than or equal to 3 mg/dl), cholangitis, or parenchymal liver d isease were excluded. The patients were randomly subjected either to dual s phincterotomy (group I, n = 30) or to pancreatic sphincterotomy alone (grou p II, n = 30). Groups I and II were further classified as IA (or IIA) and I B (or IIB), according to the level of serum alkaline phosphatase (sALP) and the diameter of the common bile duct (CBD). Group IA (or IIA) was defined when abnormal in both sALP (greater than or equal to 2 times the upper limi t of normal) and CBD diameter (greater than or equal to 12 mm), whereas gro up IB (or IIB) was defined when normal, or solely abnormal in sALP or CBD d iameter. Results: As a complication after sphincterotomy, pancreatitis developed in one of eight patients (12.5%) in group IA, whereas cholangitis occurred in one of 22 (4.5%) and hemorrhage in one of 22 (4.5%) cases in group IB. By c ontrast, in group IIA, the cholangitis developed in 56% (five of nine patie nts), which was significantly more frequent than in any other groups (P < 0 .05). Hemorrhage (one of 21, 4.8%) and pancreatitis (one of 21, 4.8%) occur red in group IIB. Conclusions: Our results suggest that dual sphincterotomy may be indicated only in patients who have both dilated choledochus and elevated alkaline ph osphatase in chronic pancreatitis. Routine biliary sphincterotomy may not b e indispensable for pancreatic sphincterotomy.