Other Specified Diseases of Biliary Tract
Conditions
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.
Interventions
DEVICEGuidewire
Use of a guidewire at ERCP for cannulating a stenosis of the biliary tract and for applying a therapeutic device (stent, dilation catheter, others)
Sponsors
Johann Wolfgang Goethe University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of guidewires per ERCP session | Within the same ERCP session (day 1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment aim | day 1 | Comparison of number of patients in whom the treatment aim could be achieved in both study groups |
| Time of ERCP session | day 1 | Comparison of time needed for the ERCP session in both study groups. |
Countries
Germany
Outcome results
None listed