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

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

Sponsors

Lead Sponsor: Assiut University

Source 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

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.

Overall Status Unknown status
Start Date 2019-01-01
Completion Date 2020-01-01
Primary Completion Date 2019-12-01
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Success rate of silver nitrate pleurodesis One week
Success rate of silver nitrate pleurodesis One month
Secondary Outcome
Measure Time Frame
Chest pain: VAS One week
Dyspnea One week
Enrollment 50
Condition
Intervention

Intervention Type: Drug

Intervention Name: Silver Nitrate

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%.

Arm Group Label: Silver Nitrate Pleurodesis

Intervention Type: Device

Intervention Name: Indwelling Pleural Catheter

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.

Arm Group Label: 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.

Gender:

All

Minimum Age:

30 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Khaled Essmat, Master

Phone: +201003382727

Email: [email protected]

Verification Date

2018-12-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Assiut University

Investigator Full Name: Khaled Essmat Hussien

Investigator Title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Silver Nitrate Pleurodesis

Type: Experimental

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

Label: Indwelling Pleural Catheter

Type: Active Comparator

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)

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

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