An analysis of the factors associated with the development of complications in patients undergoing precut sphincterotomy: a prospective, controlled, randomized, multicenter study.

OBJECTIVES: Precut is performed when biliary access at endoscopic retrograde cholangiopancreatography (ERCP) fails. Precut may have adjunctive risks, but some authors have suggested that the attempts to cannulate the papilla that precede precutting cause complications. We evaluated the role of the timing of precut in determining the development of complications and with respect to the other factors involved. METHODS: During ERCP, after 10 min of attempts to cannulate, patients were randomized to an early-precut group (n=77) undergoing precut immediately or a late-access group (n=74) in which cannulation was attempted for 10 further minutes before the endoscopist was free to perform precut or to persist in cannulation. Occurrence of complications and the associated risk factors were recorded. RESULTS: The two groups were similar for general characteristics. The number of attempts to cannulate, the number of pancreas injections, and the incidence of acinarization were higher in the late-access group. The cannulation rate was 94%. The incidence of overall complications was similar, but the pancreatitis rate was higher in the late-access group (14.9 vs. 2.6%, P=0.008). Amylase levels increased by 398.9+/-879.4 in the early-precut group and 833.6+/-1478.4 in the late-access group (P=0.029). Nondilated bile duct and pancreatic injection were related to the development of pancreatitis, whereas the performance of precut was related to other complications. CONCLUSIONS: Early precut is associated with lower pancreatitis rate, suggesting that pancreatitis develops as a consequence of the attempts to cannulate the papilla and pancreatic injection, and not precutting