Evaluation of the Clinical Safety and Performance of an Investigational Multi-Hole™ Biliary Stent for the Palliative Treatment of Malignant Biliary Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 主要终点
- Primary Endpoints
研究概览
简要总结
The objective of this study is to demonstrate clinical safety and performance of the HANAROSTENT® Multi-Hole™ Biliary Stent for the palliative treatment of malignant biliary obstruction.
详细描述
The HANAROSTENT® Multi-Hole™ Biliary Stent is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Suspected or confirmed malignant non-hilar extrahepatic biliary obstruction including any of the following measures of biliary obstruction or patients undergoing neoadjuvant cancer treatment (chemotherapy and/or radiation) for malignant biliary obstruction
- •Clinical symptoms including (e.g., cholangitis, jaundice, pruritus, pale stools, and/or dark urine)
- •Biochemical evidence (Tbili > 3mg/dL)
- •High quality imaging (e.g., ultrasound, CT, MRCP, or ERCP)
- •≥ 18 years of age
- •Willing and able to provide informed consent
排除标准
- •Participation in another investigational study within 90 days prior to consent
- •Intrahepatic metastases that extensively involve both lobes of the liver
- •Patients with a distal malignant biliary obstruction due to potential resectable disease
- •Strictures that could not be traversed by the delivery system
- •Perforation of any duct within the biliary tree
- •Presence of a biliary self-expanding metal stent (SEMS), esophageal stent, or duodenal stent
- •Active viral hepatitis
- •Life expectancy of < 3 months
- •Patient has undergone (within 30 days prior to enrollment) or is planning to undergo brachytherapy with transpapillary or percutaneous implantation of intracavitary radiation sources
- •Unwilling or unable to comply with the follow-up schedule
结局指标
主要结局
Primary Endpoints
时间窗: 6 Month
Primary Outcome Measures 1\. Clinical palliation of biliary obstruction maintenance of total bilirubin (Tbili) at 1-month follow-up \< 3 mg/dL OR Tbili reduction by \> 30% if the baseline value is \> 3 mg/dL and absence of acute cholangitis AND absence of stent-related re-intervention until death, surgery, completion of data collection at 6-month follow-up visit, or withdrawal, whichever occurs first.
次要结局
未报告次要终点