Impact of Pleural Manometry on the Assessment and Treatment of Malignant Pleural Effusion: A Pilot Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Contact Information
Primary
Ana Pardessus
anapardessusotero@gmail.com
+34691636837
Time Frame
Start Date: 2023-07-28
Estimated Completion Date: 2026-07
Participants
Target number of participants: 95
Treatments
No_intervention: Standard Care Group (No Pleural Manometry)
Patients in this group will undergo standard management for malignant pleural effusion without pleural manometry. Therapeutic decisions such as pleurodesis or placement of a tunneled pleural catheter will be made based on clinical judgment and usual care protocols, without pleural pressure measurements.
Experimental: Pleural Manometry Group
Patients in this group will undergo pleural manometry during the first thoracentesis. If pleural pressure measurements suggest that the lung expands, pleurodesis will be recommended. If the lung is non-expandable, pleurodesis will be avoided and a tunneled pleural catheter will be offered.
Related Therapeutic Areas
Sponsors
Leads: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

This content was sourced from clinicaltrials.gov