Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis

Early Phase 1

• Conditions: Pleural Effusion, Malignant; Lung Neoplasms
• Interventions: Procedure: Talc Pleurodesis; Procedure: Indwelling Pleural Catheter; Procedure: chest ultrasound; Drug: Local anesthesia; Procedure: Chest Tube

• Registration Number: NCT02825095
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Study First Submitted: 2016-04-04
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-06
• Last Update Submitted: 2016-07-06
• Study First Posted: 2016-07-07
• Last Update Posted: 2016-07-07
• Study Start: 2016-08
• Primary Completion: 2017-05
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Talc Pleurodesis	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.
Talc Pleurodesis	chest ultrasound	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.
Talc Pleurodesis	Local anesthesia	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.
Talc Pleurodesis	Chest Tube	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.
Indwelling Pleural Catheter	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.
Indwelling Pleural Catheter	chest ultrasound	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.
Indwelling Pleural Catheter	Local anesthesia	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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