Drainage of Refractory Malignant Ascites by Endoscopic Ultrasound-guided (EUS-Guided) Implantation of Plastic Prostheses
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Number of new evacuation paracentesis after the procedure.
研究概览
简要总结
This study evaluates the efficacy and safety of drainage of refractory malignant ascites by endoscopic ultrasound-guided (EUS-Guided) implantation of plastic prostheses. Patients with cancer older than 18 years with a life expectancy of less than 6 months who undergo EUS-Guided will be included in the study.
详细描述
Malignant ascites is described as the presence of fluid in the abdominal cavity due to the presence of tumors. Its appearance is a predictor of worse prognosis in the evolution of malignant neoplasm and reduces the quality of life of patients.
The use of prostheses with drainage to the gastric cavity has shown good clinical results as the reduction of paracentesis evacuation needs. This achieves the reduction of hospital admissions and the improvement of the quality of life of the patient.
In order to verify the usefulness of this drainage technique, a prospective observational study has been designed. Patients with cancer over 18 years of age will be included, with a life expectancy of less than 6 months and who have undergone drainage of refractory malignant ascites through the implantation of plastic prostheses.
Participants receive the intervention in the same manner and intensity if they are not enrolled in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Cancer patients in terminal phase with refractory malignant ascites older 18 years of age
排除标准
- •Patients under 18 years of age
- •Patients with a life expectancy greater than 6 months
- •Patients who are receiving cancer treatment for curative purposes or who suffer from a psychiatric disorder that prevents them from understanding and accepting the procedure
- •Patients who do not accept to participate in the study.
结局指标
主要结局
Number of new evacuation paracentesis after the procedure.
时间窗: At 1 week.
Paracentesis is an invasive technique that, by means of an abdominal percutaneous puncture, allows us to evacuate fluid from the peritoneal cavity. However, it only provides temporary improvement because the rapid recurrence of fluid usually occurs in about 72 hours.
次要结局
- Change in quality of life by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-palliative care (EORTC QLQ-C15-PAL)(From baseline at 1 week.)
- Change in abdominal pain by The Visual Analogue Scale (VAS).(From baseline at 1 week.)
- Change in abdominal circumference.(From baseline at 1 week.)
- Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.(At 1 week.)
- Change in Dyspnea by The modified Medical Research Council (mMRC) Scale.(From baseline at 1 week.)
- Change in weight.(Form baseline at 1 week.)