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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Radiological evidence of non-expandable lung

Life expectancy <1 month (LENT score: high risk)

Previous ipsilateral lobectomy or pneumonectomy

Previous ipsilateral chemotherapy or radiotherapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pleural manometry

    Diagnostic test

    Pleural manometry will be performed during the first thoracentesis using a water column connected to the pleural drainage system. Pleural pressure will be measured at baseline and at intervals during fluid removal to evaluate lung expandability. The water column manometer allows estimation of pressure changes in real time. Based on the pressure curve and indicators of non-expandable lung (such as early pressure drop, plateauing, or sustained negative pressures), the treatment plan will be adapted. If adequate lung re-expansion is observed, pleurodesis will be considered. If the pressure pattern suggests a non-expandable lung, pleurodesis will be avoided due to the high risk of failure, and a tunneled pleural catheter will be recommended instead.

Treatment groups

95 Participants
are divided into 2 treatment groups
Group A: Standard Care Group (No Pleural Manometry)No intervention 0 interventions
Group B: Pleural Manometry GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Successful pleurodesis based on radiographic assessment

Number of participants with successful pleurodesis, defined as absence of recurrent pleural effusion or presence of minimal or loculated effusion that does not require additional therapeutic procedures to relieve symptoms. Assessment will be performed using chest X-ray interpreted by the thoracic surgeon at the follow-up visit.

Time frame
30 days after hospital discharge

Secondary outcomes

Other outcomes

Sponsors and contacts

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