Clinical trial NCT02825095: Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis
Official title: Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis ; a Prospective Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Pleural Effusion, Malignant
Lung Neoplasms
Keywords: malignant pleural effusion,talc pleurodesis,quality of life
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change in Quality of Life
timeFrame: one year of regular follow up.
Secondary outcomes:
measure: procedure and admissions
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
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citation: Zarogoulidis K, Zarogoulidis P, Darwiche K, Tsakiridis K, Machairiotis N, Kougioumtzi I, Courcoutsakis N, Terzi E, Zaric B, Huang H, Freitag L, Spyratos D. Malignant pleural effusion and algorithm management. J Thorac Dis. 2013 Sep;5 Suppl 4(Suppl 4):S413-9. doi: 10.3978/j.issn.2072-1439.2013.09.04.
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