Clinical trial NCT03781908: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Pleural Effusion, Malignant
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Success rate of silver nitrate pleurodesis
timeFrame: One week
measure: Success rate of silver nitrate pleurodesis
timeFrame: One month
Secondary outcomes:
measure: Chest pain: VAS
timeFrame: One week
measure: Dyspnea
timeFrame: One week
Other outcomes:
Locations:
Study officials:
References:
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