Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis ; a Prospective Randomized Controlled Study.
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 120
- 主要终点
- change in Quality of Life
研究概览
简要总结
Prospective study of the effect of Talc Pleurodesis vs. Indwelling Pleural catheter in treatment of patients with malignant pleural effusion
详细描述
Randomized prospective study that will include 120 patients with malignant pleural effusion with high rate of accumulation; less than one month, The patients will be divided randomly for two groups, each group 60 patients, the first group will undergoes talc pleurodesis, the second group will undergoes Indwelling Pleural catheter insertion.
The two groups will be followed up for one year, starting at the time of intervention, after 14 days of intervention, after 30 days of intervention, once monthly for one year.
The patients will be evaluated according to the rate of complication; need for further intervention in each group, improvement of the quality of life, respiratory improvement, radiological evaluation based on chest Xray findings, rate and duration of admissions that are related to pleural effusion during the year of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with recurrent symptomatic pleural effusion, the diagnosis was obtained by : - positive cytology for malignant cells in the fluid.
- •patients well known for malignancy, with exudative pleural effusion with no alternative diagnosis.
- •pleural biopsy - surgically obtained - with diagnosis of pleural malignancy
- •microscopic intraoperative findings suggestive of pleural malignancy.
- •Patients who underwent prior to involvement in the study, draining of the pleural fluid with symptomatic improvement.
- •Patients with rate of fluid accumulation less than 30 days.
- •Patient who signed informed consent about being involved in the study.
排除标准
- •Patients under the age of 18 years.
- •Female patients who are Pregnant or nursing.
- •Patients with rate of pleural effusion accumulation is more than 30 days.
- •Patients who didn't show clinical improvement post proper draining of the fluid
- •Patients who are hemodynamically or respiratory unstable.
- •Patients with Empyema.
- •Patients who are non functioning/ not active according to the Performance status.
- •The type of malignancy which cause the malignant pleural effusion is Lymphoma.
- •Patient who underwent pneumonectomy at the side of the fluid.
- •previous pleurodesis at the side of pleural effusion.
- •Chylothorax in the initial pleural tapping.
研究组 & 干预措施
Talc Pleurodesis
For patients in this group, chest tube type PIGTAIL 10 - 14 Fr will be inserted by by chest ultrasound guided and under local anesthesia, allowing good draining of the hemithorax, in case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed, chest tube will be removed 24 - 48 hours later on. the patient will be admitted in the hospital during the whole procedure course.
If the patient developed non expanded - trapped lung post chest tube insertion, or if he had persistence high chest tube output for more than 10 days, then the patient will remain with the PIGTAIL as an Indwelling Pleural Catheter.
干预措施: Talc Pleurodesis (Procedure)
Talc Pleurodesis
For patients in this group, chest tube type PIGTAIL 10 - 14 Fr will be inserted by by chest ultrasound guided and under local anesthesia, allowing good draining of the hemithorax, in case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed, chest tube will be removed 24 - 48 hours later on. the patient will be admitted in the hospital during the whole procedure course.
If the patient developed non expanded - trapped lung post chest tube insertion, or if he had persistence high chest tube output for more than 10 days, then the patient will remain with the PIGTAIL as an Indwelling Pleural Catheter.
干预措施: chest ultrasound (Procedure)
Talc Pleurodesis
For patients in this group, chest tube type PIGTAIL 10 - 14 Fr will be inserted by by chest ultrasound guided and under local anesthesia, allowing good draining of the hemithorax, in case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed, chest tube will be removed 24 - 48 hours later on. the patient will be admitted in the hospital during the whole procedure course.
If the patient developed non expanded - trapped lung post chest tube insertion, or if he had persistence high chest tube output for more than 10 days, then the patient will remain with the PIGTAIL as an Indwelling Pleural Catheter.
干预措施: Local anesthesia (Drug)
Talc Pleurodesis
For patients in this group, chest tube type PIGTAIL 10 - 14 Fr will be inserted by by chest ultrasound guided and under local anesthesia, allowing good draining of the hemithorax, in case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed, chest tube will be removed 24 - 48 hours later on. the patient will be admitted in the hospital during the whole procedure course.
If the patient developed non expanded - trapped lung post chest tube insertion, or if he had persistence high chest tube output for more than 10 days, then the patient will remain with the PIGTAIL as an Indwelling Pleural Catheter.
干预措施: Chest Tube (Procedure)
Indwelling Pleural Catheter
All patients from this group will have Indwelling Pleural Catheter insertion type PLEURAX inserted by ultrasound guided and under local anesthesia.
the patient and his/her family will be instructed and educated about the proper way of using the catheter, and how to perform pleural draining at home.
the duration of treatment with the Pleurax depends on the rate and amount of pleural effusion draining.
干预措施: Indwelling Pleural Catheter (Procedure)
Indwelling Pleural Catheter
All patients from this group will have Indwelling Pleural Catheter insertion type PLEURAX inserted by ultrasound guided and under local anesthesia.
the patient and his/her family will be instructed and educated about the proper way of using the catheter, and how to perform pleural draining at home.
the duration of treatment with the Pleurax depends on the rate and amount of pleural effusion draining.
干预措施: chest ultrasound (Procedure)
Indwelling Pleural Catheter
All patients from this group will have Indwelling Pleural Catheter insertion type PLEURAX inserted by ultrasound guided and under local anesthesia.
the patient and his/her family will be instructed and educated about the proper way of using the catheter, and how to perform pleural draining at home.
the duration of treatment with the Pleurax depends on the rate and amount of pleural effusion draining.
干预措施: Local anesthesia (Drug)
结局指标
主要结局
change in Quality of Life
时间窗: one year of regular follow up.
the patients will be followed up 14 days post intervention, 30 days, once monthly for 12 months, the patient will fill questioner every month evaluating the quality of life, the daily activities and the degree of shortness of breath.
次要结局
- procedure and admissions(one year)