Efficacy and Safety of a Novel Guidewire for Selective Biliary Cannulation: A Multicenter, Prospective Randomized Controlled Study

Background/Aims: Guidewire selection is critical for endoscopic retrograde cholangiopancreatography (ERCP) in pancreatobiliary diseases. Our study evaluated the noninferiority of novel guidewire compared with conventional guidewire that is widely used in clinical practice.Methods: A total of 198 patients with a native papilla undergoing ERCP at three tertiary hospitals were randomized in a 1:1 ratio to the test or control group. The primary endpoint was the selective biliary cannulation success rate. The secondary endpoints were the cannulation time, the incidence of difficult cannulation, and adverse events, including post-ERCP pancreatitis (PEP). Difficult cannulation was defined as a cannulation time of >5 minutes, more than five cannulation attempts, or at least one unintentional pancreatic duct cannulation.Results: Among 198 patients analyzed (test: 98; control: 100), baseline characteristics were comparable. Selective biliary cannulation success was 99.0% in the test group and 96.0% in the control group; the between-group difference was 3.0 percentage points (95% CI, -2.2 to 8.9), with the lower CI bound above the prespecified -11% non-inferiority margin. PEP incidence was similar between groups (5.1% vs. 4.0%, p=0.746). However, difficult cannulation occurred more frequently in the test group than in the control group (29.6% vs. 15.0%; p=0.017), and the cannulation time was longer in the test group (5.7 vs. 3.4 minutes; p=0.011).Conclusions: The novel guidewire met the prespecified non-inferiority criterion for selective biliary cannulation success compared with the conventional guidewire. Adverse event rates, including PEP, were similar between the groups. The novel guidewire was associated with a longer cannulation time.