Management of Malignant Pleural Effusion With Indwelling Pleural Catheter Versus Silver Nitrate Pleurodesis

Pleural Effusion, Malignant Clinical Trial

Official title:

Management Of Malignant Pleural Effusion With Indwelling Pleural Catheter Versus Silver Nitrate Pleurodesis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03781908
• Other study ID #: silver nitrate pleurodesis
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: January 1, 2019
• Est. completion date: January 2020

Study information

• Verified date: December 2018
• Source: Assiut University
• Contact: Khaled Essmat, Master
• Phone: +201003382727
• Email: khaledessmat[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary goal of this study is to compare well-defined pleural effusion management success outcomes in patients with malignant or paramalignant pleural effusions who were treated with Indwelling pleural catheter insertion compared with those treated with siver nitrate pleurodesis. It is also to demonstrate the effectiveness of silver nitrate pleurodesis. It is also important to evaluate frequent adverse events of silver nitrate pleurodesis in patients with malignant pleural effusion

Description:

Dyspnea is present in 50% of patients with malignant pleural effusion and quality of life is significantly impaired.

Chemical pleurodesis using various sclerosing agents is accepted as a palliative therapy for patients with recurrent, symptomatic, and malignant pleural effusions.

Silver nitrate solution (SNS) is a valid sclerosing agent that induce a caustic injury to the mesothelium that results in an effective pleurodesis.

However, various clinical parameters and biochemical factors affect the success of pleurodesis in symptomatic patients with MPE: symptoms and performance status of the patient, daily fluid drainage, primary tumour, and mainly lung reexpansion following pleural fluid evacuation.

The pleural injectate consists of 50 mL 0.5% SNS with 10mL of lidocaine (25mg/5mL).

An alternative treatment is intermittent or continuous drainage of the pleural fluid with a chronic indwelling pleural catheter.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Unilateral symptomatic recurrent malignant pleural effusion patients who fulfill the criteria for pleurodesis (i.e. positive pleural biopsy or cytology for malignancy, a Karnofsky index score of more than 60 and life expectancy of more than one year).

2. Rapidly accumulated undiagnosed pleural effusion .

3. Age : 30-75 years old.

Exclusion Criteria:

1. Transudative pleural effusion.

2. Exudative pleural effusion due to causes other than malignancy ( i.e. parapnuemonic , post-tuberculous pleural effusion )

3. Presence of hemorrhagic diathesis ( prothrombin time <50% and platelet count <80,000/mm 3 )

4. Active pleural or systemic infection.

5. Neoplastic infiltration of the skin at the site of pleural catheter insertion.

6. Malignant pleural effusion with trapped lung or loculated pleural effusion.

7. Previous lobectomy or pneumonectomy on the affected side.

8. Karnofsky index score> 50.

Related Conditions & MeSH terms

• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Drug:
• Silver Nitrate
First, pleural fluid drainage will be done after administration of 5 cc of local anesthetic lidocain1% either by insertion of chest tube (26F or 28F ) or by using ultrasonography. Pleural fluid drainage will be terminated when the patient want to cough to make sure that the pleural cavity is empty, then the sclerosant material will be injected, patients will receive 0.5% silver nitrate diluted in 50 ml distilled water with 10 ml of local anaesthetic lidocaine 1%.

Device:
• Indwelling Pleural Catheter
First , insert the wire into the pleural effusion at approximately the anterior axillary line. A 1-2 cm incision is made over the wire. A chest wall tunnel (5-8 cm in length) is created with a counter incision. The catheter is pulled through the tunnel and out next to the wire. After dilation of the wire tract with a Teflon "peel-away" sheath, the indwelling catheter is inserted into the chest. The counter incision is closed primarily, and the catheter is secured to the skin medially with a suture.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (9)

Arber A, Clackson C, Dargan S. Malignant pleural effusion in the palliative care setting. Int J Palliat Nurs. 2013 Jul;19(7):320, 322-5. — View Citation

Ferlay JSH, Bray F, Forman D, Mathers C, Parkin DM, eds. Cancer incidence and mortality worldwide [webpage]. World Health Organization, International Agency for Research on Cancer; 2008. v1.2. CancerBase No. 10. http://globocan.iarc.fr. Accessed November 11, 2011.

Kalomenidis I. Beyond talc pleurodesis: do we really need new methods? Respirology. 2011 Oct;16(7):1020-2. doi: 10.1111/j.1440-1843.2011.02023.x. — View Citation

Light RW, Vargas FS. Pleural sclerosis for the treatment of pneumothorax and pleural effusion. Lung. 1997;175(4):213-23. Review. — 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

Schneider T, Reimer P, Storz K, Klopp M, Pfannschmidt J, Dienemann H, Hoffmann H. Recurrent pleural effusion: who benefits from a tunneled pleural catheter? Thorac Cardiovasc Surg. 2009 Feb;57(1):42-6. doi: 10.1055/s-2008-1039109. Epub 2009 Jan 23. — View Citation

Shaw PH, Agarwal R. WITHDRAWN: Pleurodesis for malignant pleural effusions. Cochrane Database Syst Rev. 2013 Nov 20;(11):CD002916. doi: 10.1002/14651858.CD002916.pub3. Review. — View Citation

Suárez PM, Gilart JL. Pleurodesis in the treatment of pneumothorax and pleural effusion. Monaldi Arch Chest Dis. 2013 Jun;79(2):81-6. Review. — View Citation

Tremblay A, Stather DR, Kelly MM. Effect of repeated administration of low-dose silver nitrate for pleurodesis in a rabbit model. Respirology. 2011 Oct;16(7):1070-5. doi: 10.1111/j.1440-1843.2011.02007.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of silver nitrate pleurodesis	patients will be submitted to serial chest x-ray and evaluation of pleural fluid accumulation by chest ultrasound .	One week
Primary	Success rate of silver nitrate pleurodesis	Pleural fluid re-accumulation will be evaluated by chest x-ray and chest ultrasound.	One month
Secondary	Chest pain: VAS	Chest pain will be evaluated by visual analog scale which varies from (0-10) in which grade 0 indicates no hurt and grade 10 which hurts worst	One week
Secondary	Dyspnea	Dyspnea will be evaluated through the mMRC dyspnea scale ( modified medical research council dyspnea scale) which varies from ( 0-4) in which grade 0 indicates dyspnea with sternous exercise and grade 4 which indicates dyspnea with dressing or undressing	One week