Pleural Fluid Analysis and Pleural Elastance as Predictors of Response to Pleurodesis in Patients With Malignant Pleural Effusion.
Lucía Ferreiro, Esther San José, Francisco Gude...
https://pubmed.ncbi.nlm.nih.gov/28927859Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07120867
Impact of Pleural Manometry on Assessment and Treatment of Malignant Pleural Effusion: A Pilot Clinical Trial
Led by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Updated on 2025-08-13
95
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether measuring chest pressure during pleural fluid drainage (pleural manometry) can help improve treatment choices for patients with malignant pleural effusion. This study aims to find out if using pleural manometry leads to better success rates with pleurodesis and helps guide treatment decisions. Participants have cancer with malignant pleural effusion or related conditions confirmed by tests. Participants are randomly assigned to one of two groups. One group receives standard care for malignant pleural effusion without pleural manometry, where treatment decisions are based on usual clinical judgment. The other group undergoes pleural manometry during their first fluid drainage procedure. If lung expansion looks good based on pressure measurements, pleurodesis is recommended; if the lung cannot expand well, pleurodesis is avoided and a tunneled pleural catheter is advised instead. During the study, success of pleurodesis will be assessed by chest imaging 30 days after hospital discharge. Participants will receive treatments according to their assigned group and be monitored for outcomes. The study will evaluate whether pleural manometry improves treatment success and helps select the best management approach for malignant pleural effusion.
CONDITIONS
Brief Title
Impact of Pleural Manometry on the Assessment and Treatment of Malignant Pleural Effusion: A Pilot Clinical Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically confirmed cancer
- Symptomatic patient with malignant pleural effusion confirmed by cytology
- Recurrent exudative pleural effusion without an alternative diagnosis in the context of confirmed extrapleural cancer
- Pleural effusion associated with hypermetabolic pleural thickening suggestive of malignant pleural effusion
You will not qualify if you...
- Radiological evidence of non-expandable lung
- Life expectancy less than 1 month (LENT score: high risk)
- Previous ipsilateral lobectomy or pneumonectomy
- Previous ipsilateral chemotherapy or radiotherapy
- Presence of infected pleural effusion
- Patient preference for tunneled pleural catheter placement
- Pregnancy
- Thrombocytopenia or coagulopathy
- Contraindication to general anesthesia or sedation
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 30 days after hospital discharge
Participants undergo thoracentesis with or without pleural manometry to guide treatment decisions for malignant pleural effusion. Depending on lung expandability, pleurodesis or tunneled pleural catheter placement is performed.
1 initial treatment visit and follow-up visits as needed until 30 days post-discharge
Trial Site Locations
Total: 1 location
1
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Actively Recruiting
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Research Team
A
Ana Pardessus
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Elastance of the pleural space: a predictor for the outcome of pleurodesis in patients with malignant pleural effusion.
R S Lan, S K Lo, M L Chuang...
https://pubmed.ncbi.nlm.nih.gov/9148649Pleural manometry.
John T Huggins, Peter Doelken
https://pubmed.ncbi.nlm.nih.gov/16716815Management of a malignant pleural effusion: British Thoracic Society Pleural Disease Guideline 2010.
Mark E Roberts, Edmund Neville, Richard G Berrisford...
https://pubmed.ncbi.nlm.nih.gov/20696691