Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis
NCT ID: NCT02825095
Last Updated: 2016-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
120 participants
INTERVENTIONAL
2016-08-31
2017-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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 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
chest ultrasound
All insertion of a chest drain will be guided by ultrasound
Local anesthesia
Inserting a chest drain will be after local anesthesia with 10-20 mL of Lidocaine hydrochloride 20MG/ML - Esracain injection 2%
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
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
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
Local anesthesia
Inserting a chest drain will be after local anesthesia with 10-20 mL of Lidocaine hydrochloride 20MG/ML - Esracain injection 2%
Interventions
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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
Local anesthesia
Inserting a chest drain will be after local anesthesia with 10-20 mL of Lidocaine hydrochloride 20MG/ML - Esracain injection 2%
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
90 Years
ALL
No
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Central Contacts
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References
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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.
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. No abstract available.
Sahn SA. Pleural diseases related to metastatic malignancies. Eur Respir J. 1997 Aug;10(8):1907-13. doi: 10.1183/09031936.97.10081907.
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.
Chernow B, Sahn SA. Carcinomatous involvement of the pleura: an analysis of 96 patients. Am J Med. 1977 Nov;63(5):695-702. doi: 10.1016/0002-9343(77)90154-1. No abstract available.
American Thoracic Society. Management of malignant pleural effusions. Am J Respir Crit Care Med. 2000 Nov;162(5):1987-2001. doi: 10.1164/ajrccm.162.5.ats8-00. No abstract available.
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.
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.
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.
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.
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. doi: 10.1155/2013/842768.
Other Identifiers
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0371-15rmb
Identifier Type: -
Identifier Source: org_study_id
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