NCT03672019进行中（未招募）不适用
Health-Related Quality of Life in Patients Undergoing Percutaneous Biliary Drainage For Malignant Biliary Obstruction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 118
- 试验地点
- 9
- 主要终点
- change in the FACT-Hep scores
研究概览
简要总结
The purpose of this study is to compare the participant's health-related quality of life before and after the biliary drainage procedure. The study will also help us learn whether having a drainage catheter or a stent placed during the procedure makes a difference in the participant's quality of life.
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
- 否
入选标准
- •Patients with known malignancy presenting for treatment of biliary obstruction
- •Undergoing initial Interventional Radiology PBD procedure
- •Fluent in English to enable instrument completion
- •At least18 years of age
- •Must be physically and mentally capable of completing instruments
- •Must be able to comprehend and execute informed consent
排除标准
- •Patients will be excluded if:
- •Indication for drainage is acute, symptomatic cholangitis requiring an emergent procedure
- •Previous PBD procedure
- •Presence of an indwelling biliary stent
- •Medical or psychiatric condition that, in the judgment of the consenting professional, prevents appropriate comprehension and execution of either the informed consent or the study instruments
结局指标
主要结局
change in the FACT-Hep scores
时间窗: baseline to week 4 post-procedure
The FACT-Hep minimum score is 0 and the maximum is 180.
次要结局
未报告次要终点
研究者
研究点 (9)
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