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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04074902
Other study ID # Ultrasaund after pleurodesis
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2019
Est. completion date September 2020

Study information

Verified date August 2019
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date September 2020
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Ultrasonography
Mindray dp1100 plus.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (1)

Corcoran JP, Hallifax RJ, Mercer RM, Yousuf A, Asciak R, Hassan M, Piotrowska HE, Psallidas I, Rahman NM. Thoracic Ultrasound as an Early Predictor of Pleurodesis Success in Malignant Pleural Effusion. Chest. 2018 Nov;154(5):1115-1120. doi: 10.1016/j.chest.2018.08.1031. Epub 2018 Sep 20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate and compare the outcome of pleurodisis by different modalities. To compare chest sonographic findings versus Multislice CT findings in detecting endobronchial obstruction in patients with malignant pleural effusion baseline
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Terminated NCT03325192 - Rapid Pleurodesis Through an Indwelling Pleural Catheter N/A