Management of Symptomatic Malignant Ascites With an Patient-controlled, Vascular Catheter - a Validation Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events.
研究概览
简要总结
The purpose of this study is to determine whether drainage with the usage of a fine, patient-controlled vascular catheter inserted into abdominal cavity is a feasible, safe and effective method in the management of symptomatic malignant ascites. Complications' rate of the procedure and patients' quality of life, nutritional status and experience on the treatment are main endpoints.
详细描述
Patients with symptomatic, refractory malignant ascites (MA) will be eligible for the study. In case a cancer treatment is not effective against ascites, or no target, systemic treatment is possible patients will be eligible for percutaneous placement of a vascular catheter into abdominal cavity followed be drainage performed in a regular basis when required, at home or ambulatory. Adult patients with every malignant disease, female and male, and coexisting symptomatic MA can be recruited.
Clinical, quality of life (QOL) and quality of the procedure data will be collected. The study is planned to be a multiinstitutional. A template is provided to collect essential clinical data concerned with a patient, malignant disease, procedure performance and complications. QOL and patients' experience on the treatment is to be evaluated with formal questionnaires - EORTC C15-PAL and FACIT-TS-G - permission to use granted from EORTC and FACIT respectively. Additionally, a nutrition monitoring will be performed (if possible and feasible) in patients with MA and drainage.
Data will be saved in a computer, secured data base for calculations. A cohort of 150 patients is planned to be collected. Duration of the study will depend on how many institutions will participate, and how fast patients will be recruited.
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 symptomatic, refractory malignant ascites,
- •supportive care (professional or family members) available at patients' home,
- •informed signed consent of the patient.
排除标准
- •ascites not of malignant origin,
- •asymptomatic ascites,
- •suspected or clinically apparent infection especially at the site of planned drainage placement,
- •significant coagulopathy,
- •very poor performance status (PS4),
- •patient not able to read and sign informed consent,
- •mucinous ascites.
结局指标
主要结局
Number of participants with adverse events.
时间窗: 2 weeks
Early and late adverse events of the catheter placement and later drainage to be recorded.
Change in quality of life.
时间窗: 2 weeks
Change in quality of life measured with standard questionnaire EORTC-C15-PAL before the procedure and 1-2 weeks later.
次要结局
- Patient's experience on the treatment.(2 weeks)
- Number of participants with successful catheter placement.(2 weeks)
- Number of participants with drainage complication during cancer treatment vs observation.(1 month)
- Change in nutrition habits.(2 weeks)
研究者
Maciej Stukan, MD, PhD
Dr
Gdynia Oncology Center