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

December 19, 2018 updated by: Khaled Essmat Hussien, Assiut University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
One week
Success rate of silver nitrate pleurodesis
Time Frame: One month
Pleural fluid re-accumulation will be evaluated by chest x-ray and chest ultrasound.
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One week
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
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

November 11, 2018

First Submitted That Met QC Criteria

December 19, 2018

First Posted (Actual)

December 20, 2018

Study Record Updates

Last Update Posted (Actual)

December 20, 2018

Last Update Submitted That Met QC Criteria

December 19, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • silver nitrate pleurodesis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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