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临床试验/NCT02876523
NCT02876523Unknown不适用

Biliary Hilar Drainage Managed by Endoscopy

Institut Paoli-Calmettes1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Efficacy evaluated by the need for re-interventions

研究概览

简要总结

The management of hilar biliary strictures remains difficult. These strictures are classified in 4 types (I,II,III and IV). In palliative cases, an endoscopic drainage should be performed in types I and II while a percutaneous drainage is performed in type IV. There is controversy as to whether partial or complete liver drainage should be done. Furthermore there are no standards for drainage types (metallic stents, plastic stents). Morbidity remains high and a multistage procedure can be required.

This study aims at evaluating the clinical practices in the investigators' center in order to determine the key factors that contribute to the drainage success or failure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years
  • Biliary strictures requiring a drainage

排除标准

  • Contraindication to hilar biliary drainage

结局指标

主要结局

Efficacy evaluated by the need for re-interventions

时间窗: up to 2 years

Number of re-interventions

Efficacy evaluated by the need for re-hospitalization

时间窗: up to 2 years

Number of re-hospitalization

Efficacy evaluated by complete or partial liver drainage

时间窗: up to 2 years

realization of complete or partial liver drainage

次要结局

  • Toxicity: Occurrence of drainage complications (sepsis, hemorrhage)(up to 2 years)

研究者

发起方
Institut Paoli-Calmettes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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