- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04074902
Role of Chest Sonography in Evaluation of Pleurodesis in Patients With Malignant Pleural Effusion
Role of Chest Sonography in Evaluation of Successful Pleurodesis in Patients With Malignant Pleural Effusion
Study Overview
Detailed Description
Malignant pleural effusion (MPE) imposes a significant burden on patients and health-care providers. Most of the malignant pleural effusions are the result of metastases to the pleura from other sites. The primary tumors were, in the decreasing order of frequency: lung (37%), breast (17%), unknown site (10%), lymphoma (9%), gastrointestinal (8%), ovary (7%) and mesothelioma (3%) .
Management of malignant effusions depends on palliation of dyspnea and prevention of the re accumulation of pleural fluid to provide the highest possible quality of life, regardless of the need for other treatment modalities. Most patients require definitive treatment, usually drainage and chemical pleurodesis to relieve symptoms and prevent fluid recurrence. Pleurodesis is defined as the symphysis between the visceral and parietal pleural surfaces; its function is to prevent accumulation of either air or fluid into the pleural space. Effusions of malignant origin are the most common indication for pleurodesis Thoracic ultrasound (TUS) can easily visualize pleural effusions and help in identifying malignant effusion and the presence of pleural adhesions or thick pleural peel and could therefore have a role in predicting long-term pleurodesis success or failure in MPE.
One of the easiest sign to identify during chest sonography is the movement of the visceral pleura compared to immobility of the parietal pleura. This sign of 'pleural sliding', firstly described in veterinary medicine and was used to exclude the presence of pneumothorax when present and to suspect atelectasis, fibrosis or pleural adhesions (pleurodesis) when absent. Thoracic ultrasonography easily detects the sign of 'pleural sliding', due to the movement of the visceral pleura on the parietal pleura This sign is absent when pleurodesis is successful. Contrast-enhanced chest CT has become the imaging modality of choice to detect pleural effusions and assist the differentiation between benign andmalignant effusions detected bystandard radiographs. Chest CT findings characteristic of malignant pleural disease include (i) circumferential pleural thickening, (ii) nodular pleural thickening, (iii) parietal pleural thickening greater than 1 cm, and (iv) mediastinal pleural involvement or evidence of a primary tumour.(9'10) The reported specificities of each of these individual findings range from 22% to 56% and sensitivities range from 88% to 100%.(9;11) Histological confirmation of the diagnosis, however, remains necessary. Chest CT should be performed before large-volume thoracocentesis to allow visualization of both the visceral and parietal pleurae, which may identify a pleural mass and appropriate site for needle biopsy.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Any patient with malignant pleural effusion who will undergo palliative treatment with insertion of intercostal tube.
Exclusion Criteria:
- Patients <18 years old, unable to provide informed consent.
- Had an allergy or other contraindication to intrapleural pleurodesis.
- Had evidence of unexpandable lung believed by the responsible clinician to represent insufficient.
- pleural apposition that would preclude pleurodesis, and/or had an expected survival of<1 month.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate and compare the outcome of pleurodisis by different modalities.
Time Frame: baseline
|
To compare chest sonographic findings versus Multislice CT findings in detecting endobronchial obstruction in patients with malignant pleural effusion
|
baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ultrasaund after pleurodesis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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