Efficacy and Safety of Double Guidewire Versus Transpancreatic Sphincterotomy in Difficult Biliary Cannulation: A Systematic Review and Meta‐Analysis of Randomized Clinical Trials

ABSTRACT Background Difficult biliary cannulation is a key challenge in endoscopic retrograde cholangiopancreatography and a major risk factor for post‐ ERCP pancreatitis. When the pancreatic duct is unintentionally accessed, double guidewire ( DGW ) is the primary rescue strategy, while transpancreatic sphincterotomy ( TPS ) is an alternative. Previous evidence suggests that TPS may achieve higher cannulation success and lower PEP rates compared to DGW , though direct comparative data remain limited. This review and meta‐analysis assess the clinical outcomes of TPS and DGW in the setting of difficult biliary cannulation. Methods This review involved searching Medline, Embase, Lilacs, Central Cochrane, and Google Scholar. Outcomes assessed included PEP , successful biliary cannulation, mean cannulation time, and other adverse events (bleeding, cholangitis, perforation). Results A total of 463 patients from five randomized controlled trials were included. The DGW group showed a higher risk of PEP pancreatitis and other adverse events ( p = 0.009; RR = 1.81 [1.16, 2.83]; I 2 = 34%) and ( p = 0.03; RR = 2.20 [1.10, 4.39]; I 2 = 0%), respectively. A significant difference favoring TPS was found for successful cannulation and mild pancreatitis ( p = 0.001; RR = 1.79 [1.26, 2.54]; I 2 = 40%) and ( p = 0.01; RR = 2.26 [1.20, 4.28]; I 2 = 35%), respectively. No significant difference was observed for mean cannulation time or moderate to severe PEP ( p = 0.18; SMD = −0.37 [−0.91, 0.17]; I 2 = 79%) and ( p = 0.32; RR = 1.50 [0.67, 3.36]; I 2 = 0%), respectively. A restricted analysis excluding two studies affected by external factors inflating the pancreatitis rate did not reveal a significant difference ( p = 0.61; RR = 1.16 [0.66, 2.04]; I 2 = 0%). Conclusion Prior studies comparing TPS and DGW yield different results. This may occur because there are technical variables that are difficult to control. Overall, TPS demonstrated superior cannulation success, may have lower PEP rates, and fewer other complications, although more homogeneous studies are needed to validate these findings.