Efficacy of a Newly Developed Guidewire for Selective Biliary Cannulation: A Multicenter Randomized Controlled Trial

Area of Science:

• Gastroenterology
• Endoscopic retrograde cholangiopancreatography (ERCP)
• Medical device development

Background:

• Guidewires are crucial for selective biliary cannulation during ERCP.
• Different guidewires possess unique properties influencing their efficacy.
• A novel 0.025-inch guidewire was developed for improved biliary access.

Purpose of the Study:

• To measure the physical properties of a new guidewire (NGW).
• To compare the NGW with a conventional guidewire (CGW) in terms of basic properties.
• To evaluate the clinical effectiveness of the NGW for selective biliary cannulation.

Main Methods:

• A randomized controlled trial involving 190 patients across five hospitals.
• Patients were assigned to either the NGW group (n=95) or CGW group (n=95).
• Primary outcome: selective biliary cannulation rate in naive papillae; Secondary outcomes: guidewire properties and cannulation parameters.

Main Results:

• No significant difference in cannulation success rates (75.8% NGW vs. 84.2% CGW, p=0.102) or adverse events.
• NGW group experienced more ampulla contacts (2.58 vs. 2.02, p=0.011) and longer cannulation times (216.5s vs. 135.1s, p=0.016).
• NGW exhibited higher maximum friction, lower stiffness, and better elastic resiliency compared to CGW.

Conclusions:

• The newly developed guidewire has distinct physical properties (high friction, low stiffness).
• Clinically, it achieved comparable success and safety rates to conventional guidewires.
• Increased ampulla contacts and cannulation time suggest potential challenges in its application.