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

NCT02825095 | Unknown Early Phase 1

• 1 other identifier: 0371-15rmb
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pleural Effusion, Malignant; Lung Neoplasms

Keywords

malignant pleural effusion,talc pleurodesis,quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• procedure and admissions

  one year

Study Arms (2)

Talc Pleurodesis

ACTIVE COMPARATOR

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.

Procedure: Talc Pleurodesis; Procedure: chest ultrasound; Drug: Local anesthesia; Procedure: Chest Tube

Indwelling Pleural Catheter

ACTIVE COMPARATOR

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.

Procedure: Indwelling Pleural Catheter; Procedure: chest ultrasound; Drug: Local anesthesia

Interventions

Talc Pleurodesis PROCEDURE

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

Talc Pleurodesis

Indwelling Pleural Catheter PROCEDURE

Indwelling Pleural Catheter type PLEURAX will be inserted to the pleural space. the patients will be discharged with the pleural catheter.

Indwelling Pleural Catheter

chest ultrasound PROCEDURE

All insertion of a chest drain will be guided by ultrasound

Indwelling Pleural Catheter; Talc Pleurodesis

Local anesthesia DRUG

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

Also known as: Lidocaine hydrochloride, Esracain injection 2%

Indwelling Pleural Catheter; Talc Pleurodesis

Chest Tube PROCEDURE

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

Also known as: PIGTAIL

Talc Pleurodesis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients who underwent prior to involvement in the study, draining of the pleural fluid with symptomatic improvement.
• Patients with rate of fluid accumulation less than 30 days.
• Patient who signed informed consent about being involved in the study.

You may not qualify if:

• Patients under the age of 18 years.
• Female patients who are Pregnant or nursing.
• Patients with rate of pleural effusion accumulation is more than 30 days.
• Patients who didn't show clinical improvement post proper draining of the fluid
• Patients who are hemodynamically or respiratory unstable.
• Patients with Empyema.
• Patients who are non functioning/ not active according to the Performance status.
• The type of malignancy which cause the malignant pleural effusion is Lymphoma.
• Patient who underwent pneumonectomy at the side of the fluid.
• previous pleurodesis at the side of pleural effusion.
• Chylothorax in the initial pleural tapping.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Related Publications (11)

• 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.

  PMID: 18241636 BACKGROUND

• 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.

  PMID: 20696691 BACKGROUND

• Sahn SA. Pleural diseases related to metastatic malignancies. Eur Respir J. 1997 Aug;10(8):1907-13. doi: 10.1183/09031936.97.10081907.

  PMID: 9272937 BACKGROUND

• 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.

  PMID: 20544327 BACKGROUND

• 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.

  PMID: 930945 BACKGROUND

• 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.

  PMID: 11069845 BACKGROUND

• 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.

  PMID: 24920947 BACKGROUND

• 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.

  PMID: 24102015 BACKGROUND

• 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.

  PMID: 19839739 BACKGROUND

• 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.

  PMID: 21460729 BACKGROUND

• 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.

  PMID: 23616967 BACKGROUND

MeSH Terms

Conditions

Pleural Effusion, Malignant; Lung Neoplasms

Interventions

Anesthesia, Local; Lidocaine; Chest Tubes

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases; Lung Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Surgical Equipment; Equipment and Supplies

Central Study Contacts

Ran Kremer, MD

CONTACT

00972502063189; r_kremer@rambam.health.gov.il

Amit Katz, MD

CONTACT

00972502062291; amit160275@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: July 7, 2016
• Study Start: August 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: August 1, 2017
• Last Updated: July 7, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share