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Insulation-tipped nano knife-assisted primary precut versus conventional cannulation for biliary access: a
Yonghua Shen1,2, Lichao Zhang3, Taishun Li4
1Department of Gastroenterology, Affiliated Hospital of Medical School, Nanjing Drum Tower Hospital, Nanjing University, Nanjing, China.
Background:
Endoscopic retrograde cholangiopancreatography (ERCP) remains the gold standard for Common bile duct (CBD) stone management, yet biliary cannulation challenges persist in some cases. There are limited data on primary Insulation-tipped (IT) knife precut for the biliary cannulation. Our aim was to investigate the efficacy and safety of IT nano knife-assisted primary precut in comparison to conventional cannulation for biliary access for the first time.
Methods:
This multicenter randomized controlled trial compared the efficacy and safety of primary IT knife nano-assisted precut sphincterotomy (group A) versus conventional cannulation (group B) in 340 patients with choledocholithiasis. Outcomes included initial/overall biliary cannulation success, procedural time, and adverse events (AEs).
Results:
Group A demonstrated superior initial cannulation success compared to group B (85.9% vs. 74.1%, P = 0.007), particularly in type 2 ampullary morphology (96.0% vs. 46.8%, P < 0.001). Overall success rates and cannulation time were equivalent statistically after rescue techniques. Post-precut mucosal exposure subtypes further predicted initial cannulation success [type A vs. C (100% vs. 71.0%, P < 0.001); type B vs. C (92.7% vs. 71.0%, P = 0.002)]. There were no significant differences between group A and B in the postprocedure AEs.
Conclusions:
The IT knife nano improves initial biliary cannulation success, especially in challenging type 2 ampullae, without increasing AEs. Its design enhances procedural precision, supporting primary precut as a first-line strategy. With the accumulation of data, primary IT knife nano precut may reduce reliance on repeated cannulation attempts.
