NCT03638700

Comparison of Two High Performance Guidewires in ERCP

Comparison of the Use of Two High Performance Guidewires in Patients With Stenosis of the Bile Ducts in ERCP: A Randomised Multicenter Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 453 (actual)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In ERCP guidewires are used for the insertion of endoprostheses and the cannulation of stenosis. This leads to two essential requirements for the wire systems: The use of a (highly) flexible, hydrophilic wire to achieve successful and rapid passage of the narrow passage; for additional intervention, modern wires are equipped with a stable shaft with which e.g. bougies, dilatation catheters, or stents can be introduced. Guidewires are available with angled or straight tips whose use differ regionally. Guidewires with angled tips are used predominantly in Japan, whereas in the Western world incl. Germany straight wires are commonly used. In a recently published study examining the intubation of the native papilla, successful intubation of the papilla was faster with guidewires with angled tips than with guidewires with straight tips. However, this did not result in an effect upon the time-independent rate of the successful papilla intubation. The investigators test the hypothesis that 1) a higher success rate of the ERCP can be achieved with the use of an angled guidewire than with a straight guidewire and 2) a higher success rate of the ERCP can be achieved with the use of a type 1 guidewire than with a type 2 guidewire

Detailed description

This is a randomized, multicentric study.

Conditions

• Stenosis of Bile Duct

Interventions

Type	Name	Description
DEVICE	VisiGlide™ angled tip	Arm A: Primary use of VisiGlide™ guidewire (angled tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide™ (straight tip) resp. to VisiGlid2e™ (tip according to the examiner)
DEVICE	VisiGlide2™ angled tip	Arm B: Primary use of VisiGlide2™ guidewire (angled tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide2™ (straight tip) resp. to VisiGlide™ (tip according to the examiner)
DEVICE	VisiGlide™ straight tip	Arm C: Primary use of VisiGlide™ guidewire (straight tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide™ (angled tip) resp. to VisiGlide2™ (tip according to the examiner)
DEVICE	VisiGlide2™ straight tip	Arm D: Primary use of VisiGlide2™ guidewire (straight tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide2™ (angled tip) resp. to VisiGlide1™ (tip according to the examiner)

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-10-01
• Completion: 2020-01-01
• First posted: 2018-08-20
• Last updated: 2022-05-18

Locations

1 site across 1 country: Germany