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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Enrolling

Conditions: Malignant Pleural Effusions (Mpe)

Treatments: Diagnostic Test: Pleural manometry

Study type: Interventional

Funder types: Other

Identifiers

NCT07120867

IIBSP-DPM-2022-133

Details and patient eligibility

About

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.

Enrollment: 95 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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95 participants in 2 patient groups

Standard Care Group (No Pleural Manometry)

No Intervention group

Description:

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.

Pleural Manometry Group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Pleural manometry