Primary Needle-Knife Fistulotomy versus Conventional Cannulation Method in High Risk Cohort of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Multicenter Randomized Controlled Trial

Abstract

Background: Successful biliary cannulation is a prerequisite and important component of endoscopic retrograde cholangiopancreatography (ERCP), but conventional cannulation methods (CCMs) have a post-ERCP pancreatitis (PEP) rate of 14.1% in patients at high risk for PEP. The aims of this study were to evaluate the effectiveness and safety of needle-knife fistulotomy (NKF), compared with a CCM, when used for primary biliary access in patients at high risk for developing PEP. Methods: A total of 207 patients with one or more risk factors for PEP were prospectively enrolled. The patients were randomly allocated to one of two groups according to the primary biliary cannulation technique (NKF or CCM). We compared biliary cannulation success rates, cannulation and procedure times, and the incidence of adverse events, including PEP, between the groups. Findings: The mean number of PEP risk factors was similar between the groups (NKF, 2.2 ± 1.0; CCM, 2.2 ± 0.9). PEP occurred in eight patients in the CCM group and in no patients in the NKF group (9.2% vs. 0%, p < 0.001). The rates of other complications did not differ between the groups. The biliary cannulation success rate was higher in the NKF group than in the CCM group (97.9% vs. 89.7%, p = 0.005). The mean cannulation time and total procedure time were longer in the NKF group than in the CCM group. Interpretation: NKF is an effective and safe procedure to gain primary biliary access in patients at high risk for developing PEP. Trial registration number: ClinicalTrials.gov, NCT02916199. Funding Statement: The authors state: None. Declaration of Interests: The authors state: None. Ethics Approval Statement: The study was approved by the institutional review boards of each institution (Approval number: 3-2017-0092).