A Comparative Quality of Life Assessment Between Internal Endoscopic Versus Percutaneous Drainage of Benign and Malignant Biliary Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Change in European Quality of Life-5 Dimensions questionnaire score
研究概览
简要总结
The aim of this study is to compare the quality of life in subjects with benign and malignant biliary obstruction who have or will undergo endoscopic retrograde cholangiopancreatography (ERCP) and/or percutaneous trans-hepatic biliary drainage (PTBD).
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 benign biliary obstruction
- •Patients with malignant biliary obstruction
- •Patients undergoing ERCP and/or PTBD
排除标准
- •Patients with gallstone disease
- •Patients who will undergo ERCP who have previously underwent a PTBD
- •Patients who will undergo PTBD who have previously underwent an ERCP
- •Female patients who are pregnant
- •Prisoners and other vulnerable populations
研究组 & 干预措施
ERCP
Subjects with benign and malignant biliary obstruction who have or will undergo endoscopic retrograde cholangiopancreatography (ERCP)
PTBD
Subjects with benign and malignant biliary obstruction who have or will undergo percutaneous trans-hepatic biliary drainage (PTBD).
结局指标
主要结局
Change in European Quality of Life-5 Dimensions questionnaire score
时间窗: Baseline, 1 month, 3 months
Measured using the European Quality of Life-5 Dimensions questionnaire that measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The Euro-QOL-5D score is derived from adding the scores from each of the five items. The best possible score is five (i.e., asymptomatic in each item) and the worst possible score is 15 (incapacitated in each item).
次要结局
未报告次要终点
研究者
Jad P. AbiMansour
Principal Investigator
Mayo Clinic