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NCT Number: NCT07120867

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location status: Recruiting

Location contact

Ana Pardessus

CONTACT

[email protected]

+34691636837

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Successful pleurodesis based on radiographic assessment

    Time frame: 30 days after hospital discharge

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Pardessus

CONTACT

[email protected]

+34691636837

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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