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
|Condition or disease||Intervention/treatment||Phase|
|Pleural Effusion, Malignant||Drug: Silver Nitrate Device: Indwelling Pleural Catheter||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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 .
- Success rate of silver nitrate pleurodesis [ Time Frame: One month ]Pleural fluid re-accumulation will be evaluated by chest x-ray and chest ultrasound.
- 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
- 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
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
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