Impact of Biliary Drainage on Quality Of Life in Patients With Malignant Biliary Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- To determine how surgical or percutaneous drainage affects HRQL scores in patients with MBO, and to determine if these changes are sustained or change over time.
研究概览
简要总结
You may have symptoms like itching, abdominal pain, loss of appetite, fatigue, fevers and chills. The treatment you will receive to relieve the blockage is also intended to relieve symptoms and improve your quality of life. The purpose of this study is to find out if relieving the blockage in your bile duct improves your quality of life.
详细描述
Malignant biliary obstruction (MBO) may arise in patients with cholangiocarcinoma, pancreatic carcinoma, primary gallbladder carcinoma, hepatocellular carcinoma, or metastatic disease to the liver or portal lymph nodes. MBO is often accompanied by significant symptoms that may result in impairment of health-related quality of life (HRQL), including pruritus, fever, nutritional deficits, abdominal pain, nausea and vomiting, and fatigue. Approaches to the relief of MBO include surgical bypass and/or resection, percutaneous drainage with or without biliary stenting, or endoscopic stenting. The non surgical procedures may be done prior to attempted curative resection or for palliation in individuals with unresectable or recurrent disease.
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
- •Clinical diagnosis of malignant biliary obstruction
- •Radiologic or histologic evidence of MBO
- •Percutaneous biliary drainage procedure planned or
- •Surgical biliary enteric bypass, or hepatic resection with biliary reconstruction (high bile duct tumors) planned
- •KPS >50%
- •Age 18 years or greater
- •Able to speak and read English
- •Able to comprehend and execute informed consent
- •Prior intervention for MBO not exclusionary
排除标准
- •Unable to complete questionnaire due to performance status
- •Proxy completion is not accepted
- •Medical or psychiatric condition that, in the judgment of the investigator, prevents appropriate comprehension and execution of either the informed consent or the study instrument
结局指标
主要结局
To determine how surgical or percutaneous drainage affects HRQL scores in patients with MBO, and to determine if these changes are sustained or change over time.
时间窗: conclusion of the study
次要结局
- To identify factors associated with changes in HRQL after drainage(e.g. diagnosis, level of obstruction, degree of pruritus)(conclusion of the study)