French Prospective Study on Biliary Tract Drainage Guided by Endoscopic Ultrasound in Patients With Malignant Biliary Stenosis (RAINBOW)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 162
- 试验地点
- 18
- 主要终点
- Quality of Life Measurement - Jaundice Dimension
研究概览
简要总结
The study is designed to highlight the effectiveness of the Hot AXIOS™ stent when used in accordance with standard medical practice on the evolution of the quality of life of patients with malignant biliary stenosis requiring drainage of the bile ducts after failure of ERCP, in the two months after stent placement.
详细描述
The study will evaluate the quality of life in patients with malignant biliary obstruction after the placement of a lumen-apposing metal stent via endoscopic ultrasound, with an emphasis on the improvement of quality of life measured as a reduction in jaundice. Improvement in jaundice is a direct indicator of effective bile drainage and is expected to correlate with an enhancement in overall quality of life. Quality of life will be measured by means of subject response to the EORTC QLQ-BIL21, a component of the European Organization for Research and Treatment of Cancer (EORTC) designed specifically to assess the quality of life in patients with biliary tract cancer. The QLQ-BIL21 consists of 21 questions which aim to evaluate specific symptoms and issues relevant to patients with biliary tract cancer, such as jaundice, pain, digestive problems and the psychosocial impact of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 18 years or older
- •Willing and able to comply with study procedures and provide written informed consent
- •Patients with failed ERCP for treatment of suspected malignant biliary obstruction
- •Patients for whom an indication for Hot AXIOS™ stent placement has been determined
排除标准
- •Women who are pregnant, nursing or planning to become pregnant during the study
- •Patients with immediately resectable tumor or resectable during the two months of the study
- •Patients for whom the placement of a double pigtail prosthesis is planned by the investigator during the index procedure
- •Current participation in another investigation drug or device study that could interfere with the endpoints of this study
- •Persons under guardianship or curatorship
研究组 & 干预措施
Hot AXIOS™ Recipients
The Hot AXIOS™ Stent is a flexible, fully covered self-expanding metal stent that is preloaded within the Electrocautery Enhanced Delivery System. Patients who meet all eligibility criteria will receive the Hot AXIOS™stent and their quality of life will be measured at baseline, two weeks after stent placement and two months after stent placement by the jaundice dimension of the EORTC QLQ-BIL21 questionnaire. A patient is considered enrolled after signing the study-specific Informed Consent Form (ICF). Patients who sign the ICF but subsequently do not meet one or more of the selection criteria will be considered screen failures and excluded from the study.
干预措施: Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System (Device)
结局指标
主要结局
Quality of Life Measurement - Jaundice Dimension
时间窗: 2 months (± 15 days)
The primary outcome is the difference between the measurement taken at 2 months of follow-up (± 15 days) and the baseline measurement of quality of life assessed by the jaundice dimension of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-BIL21). The QLQ-BIL21 consists of 21 questions to which respondents rate their experience with various symptoms or problems on a scale from 1 (Not at All) to 4 (Very Much); the jaundice dimension consists of three of those questions. A lower score correlates to fewer symptoms or problems.
次要结局
- Quality of Life Measurement - Non-Jaundice Dimension(2 months (± 15 days))
- Quality of Life Measurement - Global Score(2 months (± 15 days))
- Reduction in Bilirubin (Clinical Success)(2 weeks (+ 7 days) and 2 months (± 15 days))
- Rate of Resolution of Clinical Symptoms(2 months (± 15 days))
- Rate of Reintervention(2 months (± 15 days))
- Chemotherapy Status(2 months (± 15 days))
- Overall Survival(2 months (± 15 days))
- Progression-Free Survival(2 months (± 15 days))
- Number of Days Alive after Hospital Discharge(2 months (± 15 days))
- Rate of Technical Success(2 months (± 15 days))
- Serious Adverse Events(2 months (± 15 days))