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临床试验/NCT05268731
NCT05268731招募中不适用

Defining the Clinical Success of Different Percutaneous Transhepatic Biliary Drainage Procedures

Theresienkrankenhaus und St. Hedwig-Klinik GmbH1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Bilirubin value

研究概览

简要总结

The clinical success of percutaneous transhepatic biliary drainage procedures (PTBDs) is usually measured by the the decrease of the serum bilirubin value. However, the bilirubin value can be biased by other disease conditions. Furthermore, the time course of the decrease of the bilirubin value after technically successful PTBD is not well known. Serum gamma-glutamyl transferase (GGT), a liver enzyme which is typically elevated in cholestatic liver diseases, might be a good alternative to bilirubin as an indicator for the clinical success of PTBDs. The aim of this study is to analyse the bilirubin level and the GGT level in patients with technically successful PTBD.

详细描述

The medical records of adult patients who have received a technically successful PTBD will be screened sytematically in terms of bilirubin and GGT values in the follow up of 4 weeks after the intervention. Bilirubin and GGT values have been routinely examinated every 1 to 3 days. PTBD comprises external plastic endoprosthesis, combined external and internal endoprosthesis and primary metal stent insertion. The respective three procedures are considered separately. As PTBD is a rare intervention which is used after failed or impossible endoscopic retrograde cholangiopancreaticography (ERCP) medical records will be screened from 2002 to 2022 (20 years). It is expected that for example a decrease of GGT after three days might indicate a successful procedure. This in turn might has an impact on the early demission of the patient. On the other side, the precise definition of successful PTBD by bilirubin or GGT value might help to make this procedure better comparable to other alternative biliary drainage procedures such as endoscopic ultrasound-guided biliary drainage.

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • technically successful PTBD

排除标准

  • technically not successful PTBD

结局指标

主要结局

Bilirubin value

时间窗: 4 weeks

Change of serum bilirubin value

GGT value

时间窗: 4 weeks

Change of serum bilirubin value

次要结局

未报告次要终点

研究者

发起方
Theresienkrankenhaus und St. Hedwig-Klinik GmbH
申办方类型
Other
责任方
Sponsor

研究点 (1)

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