Comparison of Two High Performance Guidewires in ERCP

Stenosis of Bile Duct Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03638700
• Other study ID #: 39/16
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: January 2020

Study information

• Verified date: May 2022
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

This is a randomized, multicentric study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 453
• Est. completion date: January 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Obstruction of the biliary tract (cross sectional imaging or ultrasonography/lab data

Exclusion Criteria:

• Operatively alternated anatomy of the patient

Related Conditions & MeSH terms

• Constriction, Pathologic
• Stenosis of Bile Duct

Intervention

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)
• 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)
• 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)
• 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)

Locations

Country	Name	City	State
Germany	Goethe University Hospital Frankfurt	Frankfurt	Hessen

Sponsors (4)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital	Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor, Klinikum Stadt Hanau, Robert Bosch Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of successful passages of bilary (pancreatic) stenosis with the different guidewires.		through study completion, an average of 2 years
Secondary	Duration of ERCP session	Comparison of time needed for the ERCP session in all study groups	through study completion, an average of 2 years