A randomized trial of early precut sphincterotomy for difficult biliary access to reduce post-ERCP pancreatitis. RE-SUBMITTED to: ENDOSCOPY (November 2015)

BACKGROUND: Precut sphincterotomy is a technique usually employed during endoscopic retrograde cholangiopancreatography (ERCP) for the treatment of bile duct disease in patients with difficult biliary cannulation. It is a validated risk factor for post-ERCP pancreatitis (PEP) but it is not clear whether the risk is related to the technique itself or to repeated biliary cannulation attempts preceding it. The primary aim of the study was to assess the incidence of PEP and early precut compared with the standard technique in patients with difficult biliary cannulation. Secondary aims were to compare complications and success. Methods: In this prospective multicenter randomized clinical trial we assigned patients referred for therapeutic biliary ERCP and difficult biliary cannulation to early precut (group A) or repeated papillary cannulation attempts followed, in case of failure, by late precut (group B). PEP was defined as the onset of upper abdominal pain associated with an elevation in serum pancreatic enzymes at least three times normal at more than 24 hours after the procedure. Results: A total of 375 patients were enrolled. PEP developed in 10 of the 185 patients (5.4%) in group A and 23 of the 190 (12.1%) in group B (OR 0.35; 95%CI 0.16-0.78). The incidence of PEP in the early-precut group (10/185, 5.4%) was significantly lower than in late-precut subgroup (19/135, 14.1%) (OR 0.42, 95%CI 0.17-1.07). There were no differences in biliary cannulation success rates, bleeding, perforation, and cholangitis. Conclusions: In patients with difficult biliary cannulation, early precut is an effective technique and can significantly reduce the incidence of PEP. Repeated biliary cannulation attempts are a real risk factor for this complication.