Stenosis of Bile Duct
Conditions
Keywords
stenosis, bile duct, guidewire, ercp
Brief summary
In ERCP guidewires are used for the insertion of endoprostheses and the cannulation of stenosis. This leads to two essential requirements for the wire systems: The use of a (highly) flexible, hydrophilic wire to achieve successful and rapid passage of the narrow passage; for additional intervention, modern wires are equipped with a stable shaft with which e.g. bougies, dilatation catheters, or stents can be introduced. Guidewires are available with angled or straight tips whose use differ regionally. Guidewires with angled tips are used predominantly in Japan, whereas in the Western world incl. Germany straight wires are commonly used. In a recently published study examining the intubation of the native papilla, successful intubation of the papilla was faster with guidewires with angled tips than with guidewires with straight tips. However, this did not result in an effect upon the time-independent rate of the successful papilla intubation. The investigators test the hypothesis that 1) a higher success rate of the ERCP can be achieved with the use of an angled guidewire than with a straight guidewire and 2) a higher success rate of the ERCP can be achieved with the use of a type 1 guidewire than with a type 2 guidewire
Detailed description
This is a randomized, multicentric study.
Interventions
DEVICEVisiGlide™ angled tip
Arm A: Primary use of VisiGlide™ guidewire (angled tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide™ (straight tip) resp. to VisiGlid2e™ (tip according to the examiner)
DEVICEVisiGlide2™ angled tip
Arm B: Primary use of VisiGlide2™ guidewire (angled tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide2™ (straight tip) resp. to VisiGlide™ (tip according to the examiner)
DEVICEVisiGlide™ straight tip
Arm C: Primary use of VisiGlide™ guidewire (straight tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide™ (angled tip) resp. to VisiGlide2™ (tip according to the examiner)
DEVICEVisiGlide2™ straight tip
Arm D: Primary use of VisiGlide2™ guidewire (straight tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide2™ (angled tip) resp. to VisiGlide1™ (tip according to the examiner)
Sponsors
Klinikum Stadt Hanau
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Robert Bosch Medical Center
Johann Wolfgang Goethe University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of successful passages of bilary (pancreatic) stenosis with the different guidewires. | through study completion, an average of 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of ERCP session | through study completion, an average of 2 years | Comparison of time needed for the ERCP session in all study groups |
Countries
Germany
Outcome results
None listed