Comparison of the Guide-wire G-240 to a Combination of a Flexible/Hydrophil and a Nitinol Guide Wire

Not Applicable

Completed

• Conditions: Other Specified Diseases of Biliary Tract
• Interventions: Device: Guidewire

• Registration Number: NCT01382680
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief Summary

In ERCP practice, most often a combined use of guidewires is necessary to attain a therapeutic aim. E.g. a hyperflexible hydrophilic guidewire is changed after cannulating a stricture to a nitinol wire for improved stability with the use of therapeutic devices. A new guide-wire (G240) combines these characteristics with a stable shaft and a hydrophilic tip. The investigators test the hypothesis that the use of this new guidewire would decrease number of guidewires used within one ERCP session.

Detailed Description

This is a randomized, monocentric study.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-06-22
• Study First Submitted QC: 2011-06-24
• Study First Posted: 2011-06-27
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-16
• Last Update Posted: 2013-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

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

Exclusion Criteria

• Operatively alternated anatomy of the patient.
• Intervention of the pancreatic duct.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New guidewire (G240)	Guidewire	Primary use of the new guidewire (G240)
Classic guidewires	Guidewire	Conventional guidewires used in combination as preferred by the investigating ERCP specialist

Primary Outcome Measures

Name	Time	Method
Number of guidewires per ERCP session	Within the same ERCP session (day 1)

Secondary Outcome Measures

Name	Time	Method
Time of ERCP session	day 1	Comparison of time needed for the ERCP session in both study groups.
Treatment aim	day 1	Comparison of number of patients in whom the treatment aim could be achieved in both study groups

Trial Locations

Locations (1)

Department of Internal Medicine I; 🇩🇪 Frankfurt, Germany