NCT05600270

Angled-tip vs. Straight-tip Guidewire in Biliary Cannulation

Comparison Between an Angled-tip and Straight-tip Guidewire in Biliary Cannulation: a Prospective, Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Neev Mehta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The investigators aim is to compare outcomes between an angled-tip guidewire and a straight-tip guidewire in cannulation of the common bile duct during ERCP. This is a randomized, controlled, single-blinded study. The primary outcome is success of cannulation and secondary outcomes are incidence of post-ERCP pancreatitis, procedure duration, and rate of complication between the angled wire and straight wire.

Detailed description

Wire-guided cannulation of the common bile duct is a standard technique utilized during Endoscopic Retrograde Cholangio-Pancreatography (ERCP) to ensure safe and effective access to the common bile duct via the ampulla of Vater. Due to the anatomy of the ampulla, and the orientation of the biliary orifice, a guidewire with an angled tip may allow easier and safer access to the common bile duct without inadvertent manipulation of the pancreatic duct. The investigators aim to assess the technical and clinical outcomes between an angled-tip guidewire (GW) compared to a straight-tip guidewire in wire-guided cannulation of the common bile duct. The investigators hypothesize that an angled-tip GW is associated with increased rate of successful cannulation, decreased procedure time and decreased rate of post-ERCP pancreatitis in wire-guided biliary cannulation during ERCP.

Conditions

• Bile Duct Diseases

Interventions

Type	Name	Description
DEVICE	Angled guidewire	Cannulation of the common bile duct using an angled-tip guidewire during ERCP
DEVICE	Straight guidewire	Cannulation of the common bile duct using an straight-tip guidewire during ERCP

Timeline

• Start date: 2022-10-22
• Primary completion: 2023-08-24
• Completion: 2023-08-24
• First posted: 2022-10-31
• Last updated: 2024-10-31
• Results posted: 2024-10-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study