NCT01382680CompletedNot Applicable
Comparison of the Use of the Guide-wire G-240 to a Combination of a Flexible/Hydrophil Guide Wire With a Nitinol Wire in Patients With Stenosis of the Bile Ducts in ERCP
Johann Wolfgang Goethe University Hospital2 sites in 1 country222 target enrollmentStarted: October 1, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 222
- Locations
- 2
- Primary Endpoint
- Number of guidewires per ERCP session
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Number of guidewires per ERCP session
Time Frame: Within the same ERCP session (day 1)
Secondary Outcomes
- Time of ERCP session(day 1)
- Treatment aim(day 1)
Investigators
Jorg Albert
Johann Wolfgang Goethe-University Hospitals
Johann Wolfgang Goethe University Hospital
Study Sites (2)
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