Malignant Pleural Effusions (Mpe)NCT07120867
Impact of Pleural Manometry on the Assessment and Treatment of Malignant Pleural Effusion: A Pilot Clinical Trial
A study testing Pleural manometry in people with Malignant Pleural Effusions (Mpe), run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Effusions (Mpe)
- What is being tested?
- Pleural manometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSpain
- Study dates
- 28 Jul 2023to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy
- Thrombocytopenia or coagulopathy
- Contraindication to general anesthesia or sedation
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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.
- Conditions
- Malignant Pleural Effusions (Mpe)
- Being tested
- Pleural manometry
- Medical subject headings
- Pleural Effusion, Malignant, Myeloproliferative Disorder, Chronic, with Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleural manometryDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Group (No Pleural Manometry) | No intervention | 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 | 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. Receives: Diagnostic Test: Pleural manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start28 Jul 2023
- Primary completion20 Feb 2026
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Malignant Pleural Effusions (Mpe)Studies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120867
- Sponsor's protocol ID
- IIBSP-DPM-2022-133
- Status last verified
- Oct 2026
- First submitted
- 30 Jul 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28927859Lan 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.
PubMed 9148649Huggins JT, Doelken P. Pleural manometry. Clin Chest Med. 2006 Jun;27(2):229-40. doi: 10.1016/j.ccm.2005.12.007.
PubMed 16716815Roberts 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.
PubMed 20696691
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pleural Manometry on the Assessment and Treatment of Malignant Pleural Effusion: A Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT07120867
- Acronym / sponsor ID
- IIBSP-DPM-2022-133
- Conditions
- Malignant Pleural Effusions (Mpe)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care Group (No Pleural Manometry) | No intervention | –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 | Diagnostic Test: Pleural manometryPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed cancer and symptomatic patient with at least one of the following:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pleural manometryPleural 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. | Diagnostic test | Pleural Manometry Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 28927859Ferreiro 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.
- Background: PubMed 9148649Lan 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.
- Background: PubMed 16716815Huggins JT, Doelken P. Pleural manometry. Clin Chest Med. 2006 Jun;27(2):229-40. doi: 10.1016/j.ccm.2005.12.007.
- Background: PubMed 20696691Roberts 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.
- Individual participant dataSharing planned: No
Related trials for Malignant Pleural Effusions (Mpe)
Not yet recruitingObservational study
Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Advanced Cancer, Pleural Effusion
Recruiting
Safety and Feasibility of Medical Thoracoscopy Using Single-use Flexible Bronchoscope Versus SemiRigid Pleuroscope in Pleural Effusion
Malignant Pleural Effusions (Mpe), Medical Thoracoscopy
RecruitingEarly Phase 1
Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Not yet recruitingPhase 2
Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion
Lung Cancer (NSCLC), Malignant Pleural Effusions (Mpe)- Pleurodesis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pleural manometry in people with Malignant Pleural Effusions (Mpe), run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful pleurodesis based on radiographic assessment (time frame: 30 days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07120867, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.