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

Johann Wolfgang Goethe University Hospital

Status: Completed

Conditions: Other Specified Diseases of Biliary Tract

Treatments: Device: Guidewire

Study type: Interventional

Funder types: Other

Identifiers

NCT01382680

136/10

Details and patient eligibility

About

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.

Full description

This is a randomized, monocentric study.

Enrollment: 222 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 2 patient groups

Classic guidewires

Active Comparator group

Description:

Conventional guidewires used in combination as preferred by the investigating ERCP specialist

Treatment:

Device: Guidewire

New guidewire (G240)

Active Comparator group

Description:

Primary use of the new guidewire (G240)

Treatment:

Device: Guidewire