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Trial record 10 of 65 for:    Recruiting, Not yet recruiting, Available Studies | "Pleural Effusion"

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

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ClinicalTrials.gov Identifier: NCT03781908
Recruitment Status : Not yet recruiting
First Posted : December 20, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Khaled Essmat Hussien, Assiut University

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

Condition or disease Intervention/treatment Phase
Pleural Effusion, Malignant Drug: Silver Nitrate Device: Indwelling Pleural Catheter Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Management Of Malignant Pleural Effusion With Indwelling Pleural Catheter Versus Silver Nitrate Pleurodesis
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Silver Nitrate Pleurodesis
Patients will receive 0.5% silver nitrate diluted in 50 ml distilled water with 10 ml of local anaesthetic lidocaine 1%
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%.

Active Comparator: Indwelling Pleural Catheter
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
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 Measures :
  1. Success rate of silver nitrate pleurodesis [ Time Frame: One week ]
    patients will be submitted to serial chest x-ray and evaluation of pleural fluid accumulation by chest ultrasound .

  2. Success rate of silver nitrate pleurodesis [ Time Frame: One month ]
    Pleural fluid re-accumulation will be evaluated by chest x-ray and chest ultrasound.


Secondary Outcome Measures :
  1. Chest pain: VAS [ Time Frame: One week ]
    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

  2. Dyspnea [ Time Frame: One week ]
    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



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781908


Contacts
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Contact: Khaled Essmat, Master +201003382727 khaledessmat@outlook.com
Contact: Mohammed Abdelghany, MD +201006800525 mfawzy2013@hotmail.com

Sponsors and Collaborators
Assiut University

Publications:
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.

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Responsible Party: Khaled Essmat Hussien, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03781908     History of Changes
Other Study ID Numbers: silver nitrate pleurodesis
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Silver Nitrate
Lidocaine
Anti-Infective Agents, Local
Anti-Infective Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action