Role of Chest Sonography in Evaluation of Pleurodesis in Patients With Malignant Pleural Effusion

August 29, 2019 updated by: Safaa Ahmed EL-Sagheir Adam, Assiut University

Role of Chest Sonography in Evaluation of Successful Pleurodesis in Patients With Malignant Pleural Effusion

Thoracic ultrasonography easily detects the movement of the visceral pleura on the parietal pleura This sign is absent when pleurodesis is successful.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

100

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

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

100 patients will be chosen at random for one year from the start of the study and will be recruited from chest out patient clinc and department Assiut University hospital which are eligible for this study

Description

Inclusion Criteria:

  • Any patient with malignant pleural effusion who will undergo palliative treatment with insertion of intercostal tube.

Exclusion Criteria:

  1. Patients <18 years old, unable to provide informed consent.
  2. Had an allergy or other contraindication to intrapleural pleurodesis.
  3. Had evidence of unexpandable lung believed by the responsible clinician to represent insufficient.
  4. pleural apposition that would preclude pleurodesis, and/or had an expected survival of<1 month.

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

  • 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

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

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.

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)

September 1, 2019

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

August 28, 2019

First Submitted That Met QC Criteria

August 29, 2019

First Posted (Actual)

August 30, 2019

Study Record Updates

Last Update Posted (Actual)

August 30, 2019

Last Update Submitted That Met QC Criteria

August 29, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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