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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.
This is a randomized, monocentric study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Classic guidewires | Active Comparator | Conventional guidewires used in combination as preferred by the investigating ERCP specialist |
|
| New guidewire (G240) | Active Comparator | Primary use of the new guidewire (G240) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guidewire | Device | Use of a guidewire at ERCP for cannulating a stenosis of the biliary tract and for applying a therapeutic device (stent, dilation catheter, others) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of guidewires per ERCP session | Within the same ERCP session (day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment aim | Comparison of number of patients in whom the treatment aim could be achieved in both study groups | day 1 |
| Time of ERCP session | Comparison of time needed for the ERCP session in both study groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jörg G Albert, MD | Johann Wolfgang Goethe University Hospital and Clinics Department of Internal Medicine I | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine I | Frankfurt | 60590 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25208030 | Derived | Albert JG, Lucas K, Filmann N, Herrmann E, Schroder O, Sarrazin C, Trojan J, Kronenberger B, Bojunga J, Zeuzem S, Friedrich-Rust M. A novel, stiff-shaft, flexible-tip guidewire for cannulation of biliary stricture during endoscopic retrograde cholangiopancreatography: a randomized trial. Endoscopy. 2014 Oct;46(10):857-61. doi: 10.1055/s-0034-1377628. Epub 2014 Sep 10. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 27, 2014 | |
| Reset | Jul 24, 2014 | |
| Release | Feb 15, 2016 | |
| Reset | Mar 11, 2016 | |
| Release | Dec 13, 2017 | |
| Reset | Dec 14, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 27, 2014 | Jul 24, 2014 | |||
| Feb 15, 2016 |
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|
| day 1 |
| Mar 11, 2016 |
| Dec 13, 2017 | Dec 14, 2017 |