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

Lung Neoplasms Clinical Trial

Official title:

Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis ; a Prospective Randomized Controlled Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02825095
• Other study ID #: 0371-15rmb
• Status: Not yet recruiting
• Phase: Phase 0
• First received: April 4, 2016
• Last updated: July 6, 2016
• Start date: August 2016
• Est. completion date: August 2017

Study information

• Verified date: July 2016
• Source: Rambam Health Care Campus
• Contact: Ran Kremer, MD
• Phone: 00972502063189
• Email: r_kremer[@]rambam.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Prospective study of the effect of Talc Pleurodesis vs. Indwelling Pleural catheter in treatment of patients with malignant pleural effusion

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: August 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Procedure:
• Talc 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
• Indwelling Pleural Catheter
Indwelling Pleural Catheter type PLEURAX will be inserted to the pleural space. the patients will be discharged with the pleural catheter.
• chest ultrasound
All insertion of a chest drain will be guided by ultrasound

Drug:
• Local anesthesia
Inserting a chest drain will be after local anesthesia with 10-20 mL of Lidocaine hydrochloride 20MG/ML - Esracain injection 2%

Procedure:
• Chest 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

References & Publications (11)

American Thoracic Society. Management of malignant pleural effusions. Am J Respir Crit Care Med. 2000 Nov;162(5):1987-2001. — View Citation

Chee A, Tremblay A. The use of tunneled pleural catheters in the treatment of pleural effusions. Curr Opin Pulm Med. 2011 Jul;17(4):237-41. doi: 10.1097/MCP.0b013e3283463dac. Review. — View Citation

Chernow B, Sahn SA. Carcinomatous involvement of the pleura: an analysis of 96 patients. Am J Med. 1977 Nov;63(5):695-702. — View Citation

Heffner JE, Klein JS. Recent advances in the diagnosis and management of malignant pleural effusions. Mayo Clin Proc. 2008 Feb;83(2):235-50. doi: 10.4065/83.2.235. Review. Erratum in: Mayo Clin Proc. 2009 Sep;84(9):847. — View Citation

Nam HS. Malignant pleural effusion: medical approaches for diagnosis and management. Tuberc Respir Dis (Seoul). 2014 May;76(5):211-7. doi: 10.4046/trd.2014.76.5.211. Epub 2014 May 29. Review. — View Citation

Olden AM, Holloway R. Treatment of malignant pleural effusion: PleuRx catheter or talc pleurodesis? A cost-effectiveness analysis. J Palliat Med. 2010 Jan;13(1):59-65. doi: 10.1089/jpm.2009.0220. — View Citation

Roberts ME, Neville E, Berrisford RG, Antunes G, Ali NJ; BTS Pleural Disease Guideline Group. Management of a malignant pleural effusion: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii32-40. doi: 10.1136/thx.2010.136994. — View Citation

Sahn SA. Pleural diseases related to metastatic malignancies. Eur Respir J. 1997 Aug;10(8):1907-13. Review. — View Citation

Srour N, Amjadi K, Forster A, Aaron S. Management of malignant pleural effusions with indwelling pleural catheters or talc pleurodesis. Can Respir J. 2013 Mar-Apr;20(2):106-10. — View Citation

Uzbeck MH, Almeida FA, Sarkiss MG, Morice RC, Jimenez CA, Eapen GA, Kennedy MP. Management of malignant pleural effusions. Adv Ther. 2010 Jun;27(6):334-47. doi: 10.1007/S12325-010-0031-8. Epub 2010 Jun 10. Review. — View 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:S413-9. doi: 10.3978/j.issn.2072-1439.2013.09.04. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Quality of Life	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.	one year of regular follow up.	No
Secondary	procedure and admissions	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	one year	Yes