Impact of Pleural Manometry on the Assessment and Treatment of Malignant Pleural Effusion: A Pilot Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pleural manometry.
- Who it may be relevant to
- Registry conditions: Malignant Pleural Effusions (Mpe). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test Pleural manometry
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 adapte
Primary outcome measures
- Successful pleurodesis based on radiographic assessment [Time frame: 30 days after hospital discharge]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital de la Santa Creu i Sant Pau — Barcelona
Publications
- Ferreiro L, San Jose E, Gude F, Valdes L. Pleural Fluid Analysis and Pleural Elastance as Predictors of Response to Pleurodesis in Patients With Malignant Pleural Effusion. Arch Bronconeumol (Engl Ed). 2018 Mar;54(3):163-165. doi: 10.1016/j.arbres.2017.07.020. Epub 2017 Sep 18. No abstract available. English, Spanish. PMID 28927859
- Lan RS, Lo SK, Chuang ML, Yang CT, Tsao TC, Lee CH. Elastance of the pleural space: a predictor for the outcome of pleurodesis in patients with malignant pleural effusion. Ann Intern Med. 1997 May 15;126(10):768-74. doi: 10.7326/0003-4819-126-10-199705150-00003. PMID 9148649
- Huggins JT, Doelken P. Pleural manometry. Clin Chest Med. 2006 Jun;27(2):229-40. doi: 10.1016/j.ccm.2005.12.007. PMID 16716815
- Roberts ME, Neville E, Berrisford RG, Antunes G, Ali NJ; BTS Pleural Disease Guideline Group. Management of a malignant pleural effusion: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii32-40. doi: 10.1136/thx.2010.136994. No abstract available. PMID 20696691
Identifiers
NCT: NCT07120867 · IIBSP-DPM-2022-133