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

Primary Purpose

Pleural Effusion, Malignant

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Silver Nitrate

Indwelling Pleural Catheter

About this trial

This is an interventional treatment trial for Pleural Effusion, Malignant

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).
Rapidly accumulated undiagnosed pleural effusion .
Age : 30-75 years old.

Exclusion Criteria:

Transudative pleural effusion.
Exudative pleural effusion due to causes other than malignancy ( i.e. parapnuemonic , post-tuberculous pleural effusion )
Presence of hemorrhagic diathesis ( prothrombin time <50% and platelet count <80,000/mm 3 )
Active pleural or systemic infection.
Neoplastic infiltration of the skin at the site of pleural catheter insertion.
Malignant pleural effusion with trapped lung or loculated pleural effusion.
Previous lobectomy or pneumonectomy on the affected side.
Karnofsky index score> 50.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Silver Nitrate Pleurodesis

Indwelling Pleural Catheter

Arm Description

Patients will receive 0.5% silver nitrate diluted in 50 ml distilled water with 10 ml of local anaesthetic lidocaine 1%

Catheters will be inserted in an outpatient setting under local anaesthesia.The typical drainage schedule is every other day using disposable plastic bottles (550 mL to 1 L)

Outcomes

Primary Outcome Measures

Success rate of silver nitrate pleurodesis

patients will be submitted to serial chest x-ray and evaluation of pleural fluid accumulation by chest ultrasound .

Success rate of silver nitrate pleurodesis

Pleural fluid re-accumulation will be evaluated by chest x-ray and chest ultrasound.

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT03781908

First Posted

November 11, 2018

Last Updated

December 19, 2018

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03781908

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2019 (Anticipated)

Primary Completion Date

December 1, 2019 (Anticipated)

Study Completion Date

January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pleural Effusion, Malignant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Silver Nitrate Pleurodesis

Arm Type

Experimental

Arm Description

Patients will receive 0.5% silver nitrate diluted in 50 ml distilled water with 10 ml of local anaesthetic lidocaine 1%

Arm Title

Indwelling Pleural Catheter

Arm Type

Active Comparator

Arm Description

Catheters will be inserted in an outpatient setting under local anaesthesia.The typical drainage schedule is every other day using disposable plastic bottles (550 mL to 1 L)

Intervention Type

Drug

Intervention Name(s)

Silver Nitrate

Intervention Description

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%.

Intervention Type

Device

Intervention Name(s)

Indwelling Pleural Catheter

Intervention Description

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.

Primary Outcome Measure Information:

Title

Success rate of silver nitrate pleurodesis

Description

patients will be submitted to serial chest x-ray and evaluation of pleural fluid accumulation by chest ultrasound .

Time Frame

One week

Title

Success rate of silver nitrate pleurodesis

Description

Pleural fluid re-accumulation will be evaluated by chest x-ray and chest ultrasound.

Time Frame

One month

Secondary Outcome Measure Information:

Title

Chest pain: VAS

Description

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

Time Frame

One week

Title

Dyspnea

Description

Time Frame

One week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Rapidly accumulated undiagnosed pleural effusion . Age : 30-75 years old. Exclusion Criteria: Transudative pleural effusion. Exudative pleural effusion due to causes other than malignancy ( i.e. parapnuemonic , post-tuberculous pleural effusion ) Presence of hemorrhagic diathesis ( prothrombin time <50% and platelet count <80,000/mm 3 ) Active pleural or systemic infection. Neoplastic infiltration of the skin at the site of pleural catheter insertion. Malignant pleural effusion with trapped lung or loculated pleural effusion. Previous lobectomy or pneumonectomy on the affected side. Karnofsky index score> 50.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Khaled Essmat, Master

Phone

+201003382727

khaledessmat@outlook.com

First Name & Middle Initial & Last Name or Official Title & Degree

Mohammed Abdelghany, MD

Phone

+201006800525

mfawzy2013@hotmail.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

21790880

Citation

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. No abstract available.

Results Reference

background

PubMed Identifier

20696691

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. No abstract available.

Results Reference

background

PubMed Identifier

21651643

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.

Results Reference

background

PubMed Identifier

24259053

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. No abstract available.

Results Reference

background

PubMed Identifier

24273808

Citation

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.

Results Reference

background

PubMed Identifier

24354096

Citation

Suarez PM, Gilart JL. Pleurodesis in the treatment of pneumothorax and pleural effusion. Monaldi Arch Chest Dis. 2013 Jun;79(2):81-6. doi: 10.4081/monaldi.2013.96.

Results Reference

background

PubMed Identifier

19169996

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.

Results Reference

background

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.

Results Reference

background

PubMed Identifier

9195549

Citation

Light RW, Vargas FS. Pleural sclerosis for the treatment of pneumothorax and pleural effusion. Lung. 1997;175(4):213-23. doi: 10.1007/pl00007568.

Results Reference

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

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