Angled-tip vs. straight-tip guidewire in ERCP: a randomized, multicenter study

Area of Science:

• Gastroenterology
• Medical Devices
• Interventional Endoscopy

Background:

• Endoscopic retrograde cholangiopancreatography (ERCP) is a key intervention for biliopancreatic diseases.
• Guidewires are critical components for successful ERCP procedures.

Purpose of the Study:

• To compare the efficacy of hydrophilic guidewires with straight versus angled tips in ERCP.
• To evaluate the impact of guidewire tip flexibility (normal vs. enhanced) on ERCP success rates and procedure duration.

Main Methods:

• A randomized, multicenter, open-label study involving 453 patients requiring guidewire use during ERCP.
• Patients were randomized to receive either a straight tip (ST) or angled tip (AT) hydrophilic guidewire, with stratification by indication.
• Success rate and procedural duration were primary endpoints; cross-over was permitted.

Main Results:

• Overall success was achieved in 86% of procedures with the initially allocated guidewire.
• Angled tip guidewires demonstrated a significantly higher success rate (87.5%) compared to straight tip guidewires (79.9%) (p=0.049).
• Success rates for intrahepatic strictures were markedly higher with angled tips (90.7%) versus straight tips (69.1%) (p=0.008).

Conclusions:

• ERCP guidewires with an angled tip configuration are more successful than straight tip wires, particularly for intrahepatic strictures.
• Guidewire tip flexibility (standard vs. enhanced) did not significantly influence success rates across all indications.