Impact of Pleural Manometry on the Assessment and Treatment of Malignant Pleural Effusion: A Pilo… (NCT07120867) | Clinical Trial Compass
RecruitingNot Applicable
Impact of Pleural Manometry on the Assessment and Treatment of Malignant Pleural Effusion: A Pilot Clinical Trial
Spain95 participantsStarted 2023-07-28
Plain-language summary
The goal of this clinical trial is to find out if performing a pleural fluid drainage (thoracentesis) together with the measurement of pressure inside the chest (pleural manometry) during the same procedure can help doctors choose the best treatment for each patient with malignant pleural effusion.The main questions it aims to answer are:
* Is the use of pleural manometry associated with a higher success rate in managing malignant pleural effusion through pleurodesis?
* Can the use of pleural manometry help guide optimal therapeutic decision-making in malignant pleural effusion?
Researchers will compare the success of the chosen treatment in patients who undergo pleural manometry to those who do not, to see if pleural manometry helps improve treatment outcomes for malignant pleural effusion.
Participants will:
* Receive treatment according to the hospital's standard clinical practice for managing malignant pleural effusion.
* If assigned to the manometry group, they will undergo pleural manometry during their first thoracentesis.
* If the manometry results suggest that the lung can fully expand, they will be referred for pleurodesis-just as patients in the non-manometry group are.
* If the manometry results suggest that the lung cannot fully expand, pleurodesis will not be recommended due to the high risk of failure. Instead, placement of a tunneled pleural catheter will be advised to help control symptoms.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed cancer and symptomatic patient with at least one of the following:
* 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.
Exclusion Criteria:
* Radiological evidence of non-expandable lung
* Life expectancy \<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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Successful pleurodesis based on radiographic assessment
Timeframe: 30 days after hospital discharge
Trial details
NCT IDNCT07120867
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau