NCT03781908

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

December 20, 2018

Status Verified

December 1, 2018

Enrollment Period

11 months

First QC Date

November 11, 2018

Last Update Submit

December 19, 2018

Conditions

Pleural Effusion, Malignant

Outcome Measures

Primary Outcomes (2)

  • 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

  • Success rate of silver nitrate pleurodesis

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

    One month

Secondary Outcomes (2)

  • Chest pain: VAS

    One week

  • Dyspnea

    One week

Study Arms (2)

Silver Nitrate Pleurodesis

EXPERIMENTAL

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

Drug: Silver Nitrate

Indwelling Pleural Catheter

ACTIVE COMPARATOR

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)

Device: Indwelling Pleural Catheter

Interventions

Silver NitrateDRUG

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%.

Silver Nitrate Pleurodesis
Indwelling Pleural CatheterDEVICE

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.

Indwelling Pleural Catheter

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 21790880BACKGROUND

  • 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: 20696691BACKGROUND

  • 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.

    PMID: 21651643BACKGROUND

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

    PMID: 24259053BACKGROUND

  • 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.

    PMID: 24273808BACKGROUND

  • 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.

    PMID: 24354096BACKGROUND

  • 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.

    PMID: 19169996BACKGROUND

  • 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.

    BACKGROUND

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

    PMID: 9195549BACKGROUND

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

Silver Nitrate

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural EffusionPleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

NitratesNitric AcidNitrogen CompoundsInorganic ChemicalsSilver Compounds

Central Study Contacts

Khaled Essmat, Master

CONTACT

+201003382727khaledessmat@outlook.com

Mohammed Abdelghany, MD

CONTACT

+201006800525mfawzy2013@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 11, 2018

First Posted

December 20, 2018

Study Start

January 1, 2019

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

December 20, 2018

Record last verified: 2018-12