Pleural Effusion, Malignant, Lung Neoplasms
Conditions
Keywords
malignant pleural effusion,talc pleurodesis,quality of life
Brief summary
Prospective study of the effect of Talc Pleurodesis vs. Indwelling Pleural catheter in treatment of patients with malignant pleural effusion
Detailed description
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.
Interventions
PROCEDURETalc Pleurodesis
chest tube type PIGTAIL 10 - 14 Fr will be inserted to the pleural space. In case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed
PROCEDUREIndwelling Pleural Catheter
Indwelling Pleural Catheter type PLEURAX will be inserted to the pleural space. the patients will be discharged with the pleural catheter.
PROCEDUREchest ultrasound
All insertion of a chest drain will be guided by ultrasound
DRUGLocal anesthesia
Inserting a chest drain will be after local anesthesia with 10-20 mL of Lidocaine hydrochloride 20MG/ML - Esracain injection 2%
PROCEDUREChest Tube
chest tube type PIGTAIL 10 - 14 Fr will be inserted to the pleural space. In case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Patients who underwent prior to involvement in the study, draining of the pleural fluid with symptomatic improvement. 3. Patients with rate of fluid accumulation less than 30 days. 4. Patient who signed informed consent about being involved in the study.
Exclusion criteria
1. Patients under the age of 18 years. 2. Female patients who are Pregnant or nursing. 3. Patients with rate of pleural effusion accumulation is more than 30 days. 4. Patients who didn't show clinical improvement post proper draining of the fluid 5. Patients who are hemodynamically or respiratory unstable. 6. Patients with Empyema. 7. Patients who are non functioning/ not active according to the Performance status. 8. The type of malignancy which cause the malignant pleural effusion is Lymphoma. 9. Patient who underwent pneumonectomy at the side of the fluid. 10. previous pleurodesis at the side of pleural effusion. 11. Chylothorax in the initial pleural tapping.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in Quality of Life | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| procedure and admissions | one year | The patients will be evaluated for the number of admissions: e.g: how many times he/she was admitted to the hospital, duration of admissions; how many days he was admitted in the hospital each time and procedure related to pleural effusion; types and number of procedures |
Contacts
Primary ContactRan Kremer, MD
Backup ContactAmit Katz, MD
Outcome results
None listed