Abstract

The goal of this study was to compare the efficacy and safety of needle-knife fistulotomy (NKF) to that of conventional cannulation methods (CCMs) when used for primary biliary access in patients with duodenalpapillary tumors. Consecutive patients who had duodenalpapillary tumors and who underwent endoscopic retrograde cholangiopancreatography (ERCP) were retrospectively enrolled. Successful cannulation rates, cannulation and procedure times, and the prevalence of adverse events were compared between the NKF and CCM groups. A total of 404 patients (NKF, n = 124; CCM, n = 280) with duodenalpapillary tumors were included. The primary and overall cannulation rates were 92.1% (372/404) and 96.0% (388/404), respectively. Compared to CCMs, NKF was associated with a significantly higher successful cannulation rate (99.2% versus 88.9%, P < 0.001) and significantly lower cannulation times (2.1 ± 2.0min versus 4.7 ± 5.2min), procedure times (8.8 ± 3.8min versus 12.9 ± 7.6min), and unintentional pancreatic duct cannulation rates (1.6% versus 20%), with P < 0.001 for all. Overall adverse events occurred less frequently in the NKF group (3.2% versus 10.7%, P = 0.011). Of these adverse events, post-ERCP pancreatitis (PEP) was significantly lower in the NKF group than in the CCM group (1.6% versus 6.8%, P = 0.03). Bleeding and cholangitis rarely occurred with either cannulation method (0.8% versus 2.1%, P = 0.681, and 0.8% versus 1.7%, P = 0.671, respectively). NKF is a more effective and safer procedure than CCMs for patients with duodenalpapillary tumors.

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