NCT02028845

Loop-tipped Guidewire in Selective Biliary Cannulation

Loop-tipped Guidewire in Selective Biliary Cannulation: a Prospective, Randomized, Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Ajou University School of Medicine · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

1. Background * Advanced guidewires with a U-shaped tip could effectively cross the long or multi-occlusive segment smoothly and go into the distal outflow vessel. * The guidewire looping technique is a safe and effective method for the recanalization of the occluded lesions in infrapopliteal vessels. 2. Objective - To compare the performance a loop-tipped guidewire with a straight-tipped guidewire in achieving successful deep biliary cannulation. 3. Design \- Prospective randomized trial. 4. Setting: \- Tertiary-care medical center 5. Patients \- This study will involve 192 patients with biliary diseases which require endoscopic retrograde cholangiopancreatography. 6. Intervention - Cannulation of bile duct by using a loop-tipped guidewire or a straight-tipped guidewire 7. Main outcome measurements - Compare the cannulation success rate, the duration of the cannulation, immediate and late complications.

Conditions

• Choledocholithiasis
• Bile Duct Cancer
• Pancreatic Cancer
• Ampullary Tumor

Interventions

Type	Name	Description
DEVICE	Biliary cannulation with loop guidewire	Selective biliary cannulation during endoscopic retrograde cholangiopancreatography
DEVICE	Biliary cannulation with straight guidewire	Selective biliary cannulation during endoscopic retrograde cholangiopancreatography

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-01-07
• Last updated: 2016-01-05

Locations

1 site across 1 country: South Korea