Pleural manometry during thoracentesis to guide treatment of malignant pleural effusion
Impact of Pleural Manometry on the Assessment and Treatment of Malignant Pleural Effusion: A Pilot Clinical Trial
This trial will test whether measuring chest pressure (pleural manometry) while draining fluid helps doctors choose better treatments for people with malignant pleural effusion.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 95 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT07120867 on ClinicalTrials.gov |
What this trial studies
This pilot interventional trial compares outcomes for patients who have pleural manometry performed during thoracentesis with those who undergo standard thoracentesis without manometry. Participants receive usual hospital care for malignant pleural effusion, and clinicians use manometry readings when present to inform decisions such as attempting pleurodesis versus alternative management. The primary outcomes include success rates of the chosen treatment (for example pleurodesis) and whether manometry changes therapeutic decisions. Results will be used to determine if larger trials are warranted and to refine patient-selection and procedural protocols.
Who should consider this trial
Good fit: Ideal candidates are adults with symptomatic malignant pleural effusion confirmed by cytology or compatible imaging who are fit for thoracentesis and do not have contraindications to the procedure or sedation.
Not a fit: Patients with radiological evidence of non-expandable lung, infected effusions, very limited life expectancy, prior ipsilateral lung resection or those who prefer tunneled pleural catheters are unlikely to benefit from pleural manometry-guided management.
Why it matters
Potential benefit: If successful, using pleural manometry could increase the chance of successful pleurodesis and help personalize treatment choices, potentially reducing repeat procedures and hospital time.
How similar studies have performed: Previous work has used pleural manometry to detect non-expandable lung and guide drainage decisions, but direct evidence that manometry improves pleurodesis success is limited and this pilot seeks to compare outcomes more directly.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Barcelona
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Ana Pardessus
- Email: anapardessusotero@gmail.com
- Phone: +34691636837
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.