Comparison of the Use of Two High Performance Guidewires in Patients With Stenosis of the Bile Ducts in ERCP: A Randomised Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 453
- 试验地点
- 1
- 主要终点
- Number of successful passages of bilary (pancreatic) stenosis with the different guidewires.
研究概览
简要总结
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
详细描述
This is a randomized, multicentric study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obstruction of the biliary tract (cross sectional imaging or ultrasonography/lab data
排除标准
- •Operatively alternated anatomy of the patient
研究组 & 干预措施
guidewire type 2: VisiGlide2™ straight tip
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 VisiGlide™ (tip according to the examiner)
干预措施: VisiGlide™ straight tip (Device)
guidewire type 2: VisiGlide2™ straight tip
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 VisiGlide™ (tip according to the examiner)
干预措施: VisiGlide2™ straight tip (Device)
guidewire type 1: VisiGlide™ angled tip
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)
干预措施: VisiGlide™ angled tip (Device)
guidewire type 1: VisiGlide™ angled tip
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)
干预措施: VisiGlide2™ angled tip (Device)
guidewire type 1: VisiGlide™ angled tip
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)
干预措施: VisiGlide™ straight tip (Device)
guidewire type 1: VisiGlide™ angled tip
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)
干预措施: VisiGlide2™ straight tip (Device)
guidewire type 2: VisiGlide2™ angled tip
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 VisiGlide™ (tip according to the examiner)
干预措施: VisiGlide™ angled tip (Device)
guidewire type 2: VisiGlide2™ angled tip
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 VisiGlide™ (tip according to the examiner)
干预措施: VisiGlide2™ angled tip (Device)
guidewire type 2: VisiGlide2™ angled tip
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 VisiGlide™ (tip according to the examiner)
干预措施: VisiGlide™ straight tip (Device)
guidewire type 2: VisiGlide2™ angled tip
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 VisiGlide™ (tip according to the examiner)
干预措施: VisiGlide2™ straight tip (Device)
guidewire type 1: VisiGlide™ straight tip
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)
干预措施: VisiGlide™ angled tip (Device)
guidewire type 1: VisiGlide™ straight tip
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)
干预措施: VisiGlide2™ angled tip (Device)
guidewire type 1: VisiGlide™ straight tip
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)
干预措施: VisiGlide™ straight tip (Device)
guidewire type 1: VisiGlide™ straight tip
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)
干预措施: VisiGlide2™ straight tip (Device)
guidewire type 2: VisiGlide2™ straight tip
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 VisiGlide™ (tip according to the examiner)
干预措施: VisiGlide™ angled tip (Device)
guidewire type 2: VisiGlide2™ straight tip
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 VisiGlide™ (tip according to the examiner)
干预措施: VisiGlide2™ angled tip (Device)
结局指标
主要结局
Number of successful passages of bilary (pancreatic) stenosis with the different guidewires.
时间窗: through study completion, an average of 2 years
次要结局
- Duration of ERCP session(through study completion, an average of 2 years)
研究者
Jorg Albert
Prof. Dr.
Johann Wolfgang Goethe University Hospital