Pneumothorax Spontaneous PrimaryNCT07167992
Comparison of Talc Slurry Versus Talc Insufflation: A Study on Effectiveness, Safety, and Hospital Outcomes in Pleurodesis
A study testing Pleurodesis in people with Pneumothorax Spontaneous Primary and Pneumothorax Spontaneous Secondary, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial summary
Pleural effusion is characterized by the accumulation of fluid in the pleural space, which typically contains about 10-20 mL of pleural fluid that is crucial for the movement of the lungs against the chest wall. This fluid closely resembles plasma but has a lower protein concentration, usually less than 1.5 gm/dL. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Pneumothorax Spontaneous Primary, Pneumothorax Spontaneous Secondary, Pleural Effusion, Malignant
- What is being tested?
- Pleurodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2026to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients aged 12 years and older.
- Diagnosed with malignant pleural effusions or pneumothoraces.
- ECOG performance status of 0-2.
- Life expectancy of at least 3 months.
- Ability to provide informed consent.
- No contraindications to general anesthesia or conscious sedation.
Who cannot join
- Patients younger than 12 years old
- Female patients who are pregnant or lactating
- Patients with encysted or septated pleural effusions and pneumothoraces
- Patients presenting with respiratory failure
- Patients complaining of dyspnea in spite of complete evacuation of pleural effusion or pneumothorax.
- Patients with evident chest infection with clinical or laboratory signs suggestive of parapneumonic effusions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Services Institute of Medical Sciences (SIMS), Services Hospital Lahore
Lahore, Punjab Province, 54000
About this study
Pleural effusion is characterized by the accumulation of fluid in the pleural space, which typically contains about 10-20 mL of pleural fluid that is crucial for the movement of the lungs against the chest wall. This fluid closely resembles plasma but has a lower protein concentration, usually less than 1.5 gm/dL. It primarily originates from pleural capillaries and the interstitial spaces of the lung, and is reabsorbed through the lymphatic vessels in the parietal pleura, either via small openings known as stomas or through a process called transcytosis (1, 2). When the balance between fluid production and reabsorption is disrupted-often due to various pathogenic mechanisms-it can lead to pleural effusion. In such cases, effective management is essential. This study aims to conduct a thorough comparison of the two talc administration methods-TS and TI-using sterilized, large-particle, asbestos-free talc powder. By examining key outcome measures such as pleurodesis success rates, procedural morbidity, and length of hospital stay, the goal is to provide clinicians with evidence-based guidance to facilitate informed decision-making in the management of pleural effusions.
Read the detailed description
One of the most effective interventions for managing malignant pleural effusion (MPE) and pneumothoraces is chemical pleurodesis, which involves the introduction of a sclerosing agent into the pleural space to induce inflammation and subsequent fibrosis, thereby closing the pleural space. Among the various agents used, talc is the most widely recognized for its high success rates, affordability, and availability (3-8). There are primarily two methods of delivering talc: talc slurry (TS), which involves injecting a talc suspension via a chest tube, and talc insufflation (TI), which is performed during thoracoscopic surgery. Currently, there is no consensus on which method is superior, leading to a recommendation for individualized patient approaches that consider the specific clinical scenario and aim to minimize complications while reducing hospital stays9 .
The choice of talc particle size is critical, as it has significant implications for both the efficacy of pleurodesis and the safety of the procedure. Historically, small-particle talc formulations (less than 10 μm) have been associated with severe complications such as acute respiratory distress syndrome (ARDS) 10. This has prompted a shift toward using larger particles (greater than 15 μm), which have been shown to decrease the risk of ARDS and other respiratory complications. Importantly, studies have demonstrated that the effectiveness of pleurodesis is not compromised by the use of larger particles11.Furthermore, recommendations now advocate for the use of a minimum effective dose of talc, typically around 4-5 grams, to optimize both efficacy and safety.
Another significant advancement in the use of talc for pleurodesis is the transition to asbestos-free formulations. Historically, some talc preparations contained trace amounts of asbestos, a known carcinogen linked to serious health risks such as mesothelioma. The move toward asbestos-free talc has been driven by the need to eliminate these long-term carcinogenic risks, especially in patients who may have a prolonged survival following pleurodesis. Despite significant advancements in the use of talc pleurodesis, several important gaps remain in the literature. Notably, there is a lack of comprehensive studies focusing on the efficacy and safety of large-particle (≥15 μm), asbestos-free talc. While this formulation has been associated with a reduced risk of complications such as acute respiratory distress syndrome (ARDS), most existing research has centered on smaller-particle talc or formulations with less stringent quality controls. Furthermore, the comparative effectiveness of talc slurry (TS) and talc insufflation (TI) using modern, large-particle, asbestos-free talc is underexplored. The absence of such data hinders the development of evidence-based guidelines for selecting the optimal delivery method for individual clinical scenarios While these advancements have improved the risk-benefit profile of talc pleurodesis, it is important to recognize that the procedure is not without risks. Thus, careful patient selection and monitoring remain essential to minimize complications 12. Reducing hospital stays and procedural morbidity is critical in improving patient outcomes, especially for individuals with malignant pleural effusion (MPE) or recurrent pneumothoraces. These conditions often affect patients with advanced malignancies or significant comorbidities, where maintaining quality of life is paramount. Shorter hospital stays and fewer complications directly enhance patients' overall well-being and comfort, particularly for those with limited life expectancy. Additionally, minimizing hospital stays alleviates the economic and logistical burdens on healthcare systems, promoting the broader implementation of pleurodesis as a sustainable intervention.
International guidelines, such as those issued by the British Thoracic Society (BTS), provide valuable insights into the current standards of care for pleurodesis. These guidelines recommend talc pleurodesis as a primary intervention for symptomatic management of recurrent pleural effusions and pneumothoraces when pleural drainage alone proves insufficient. Talc remains the preferred agent due to its high efficacy and relative safety profile. However, the BTS guidelines do not strongly favor one delivery method-talc slurry or talc insufflation-over the other, advocating instead for individualized approaches based on patient needs and resource availability. The guidelines emphasize the importance of using sterilized, asbestos-free, large-particle talc to reduce the risk of complications, including ARDS and long-term carcinogenic effects13.
- Conditions
- Pneumothorax Spontaneous Primary, Pneumothorax Spontaneous Secondary, Pleural Effusion, Malignant, Pleurodesis
- Being tested
- Pleurodesis
- Keywords
- Talc slurry, Talc Insufflation, Pleurodesis, malignant pleural effusions, recurrent pneumothorax
- Medical subject headings
- Pneumothorax, Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PleurodesisProcedure or surgery
Talc slurry pleurodesis is a chemical technique for managing recurrent pleural effusions and pneumothoraces. The procedure involves instilling a suspension of talc (4-5 grams) in sterile saline (50-100 mL) into the pleural space via a chest tube. This induces an inflammatory reaction, leading to fibrosis and fusion of pleural surfaces. The technique demonstrates 70-90% success rates in malignant pleural effusions and pneumothoraces, with efficacy comparable to talc poudrage. While generally safe, potential complications include pain, fever, and rarely, pneumonitis or empyema. Use of large-particle, asbestos-free talc and standardized protocols has improved its safety profile.
pleurodesisProcedure or surgery
Talc insufflation, is a pleurodesis technique involving direct insufflation of dry talc powder into the pleural cavity during thoracoscopy. It allows visual inspection of the pleural space and concurrent diagnostic procedures. Success rates range from 85% to 93% for malignant pleural effusions and pneumothoraces, with efficacy comparable or potentially superior to talc slurry in some studies. The procedure typically requires general anesthesia and is more invasive than talc slurry. Common side effects include chest pain, fever, and dyspnea. The risk of severe respiratory complications has decreased with large-particle, asbestos-free talc. While effective, the choice between insufflation and slurry depends on patient factors, institutional expertise, and resource availability.
| Study group | Role | What they receive |
|---|---|---|
| Talc Slurry Group | Experimental | patient undergoing pleurodesis by talc slurry method are included in this group Receives: Procedure: Pleurodesis |
| Talc Insufflation Group | Experimental | patient undergoing pleurodesis by talc insufflation method are included in this group Receives: Procedure: pleurodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of Pleurodesis
The success rate of pleurodesis is defined as the percentage of patients who achieve complete resolution of pleural effusion or pneumothorax within a specified time frame of 01 months post-procedure. Success is assessed through follow-up chest radiographs, with criteria for success including the absence of fluid reaccumulation or lung collapse during this period. Clinical improvement in symptoms such as dyspnea may also be considered as supplementary evidence of a successful outcome.
Measured: 01 months post-procedure
Secondary outcomes (1)
Procedural Morbidity of pleurodesis
Procedural morbidity refers to the incidence and severity of complications directly attributable to the pleurodesis procedure, occurring within 30 days post-procedure.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Feb 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumothorax Spontaneous PrimaryStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe 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
- Model description
- This study will be a randomized controlled trial (RCT) to ensure robust comparisons between talc slurry (TS) and talc insufflation (TI) in managing pleural effusions or pneumothoraces. To reduce bias, the study will be single-blind, where patients will be unaware of the procedure type, while clinicians will know the intervention. This design minimizes performance and response biases without compromising the feasibility of the procedures.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeeshan Sarwar, University of Health Sciences Lahore
- Investigators
- Muhammad Shoaib Nabi, Professor of Thoracic Surgery, Study chair, Services institute of Medical Sciences (SIMS), Services Hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167992
- Sponsor's protocol ID
- IRB/2025/1559/SIMS
- Status last verified
- Jan 2026
- First submitted
- 4 Sep 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Talc Slurry Versus Talc Insufflation: A Study on Effectiveness, Safety, and Hospital Outcomes in Pleurodesis
- ClinicalTrials.gov ID
- NCT07167992
- Acronym / sponsor ID
- IRB/2025/1559/SIMS
- Conditions
- Pneumothorax Spontaneous Primary, Pneumothorax Spontaneous Secondary, Pleural Effusion, Malignant, Pleurodesis
- Keywords
- Talc slurry, Talc Insufflation, Pleurodesis, malignant pleural effusions, recurrent pneumothorax
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 11 Sep 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.
Pleural effusion is characterized by the accumulation of fluid in the pleural space, which typically contains about 10-20 mL of pleural fluid that is crucial for the movement of the lungs against the chest wall. This fluid closely resembles plasma but has a lower protein concentration, usually less than 1.5 gm/dL. It primarily originates from pleural capillaries and the interstitial spaces of the lung, and is reabsorbed through the lymphatic vessels in the parietal pleura, either via small openings known as stomas or through a process called transcytosis (1, 2). When the balance between fluid production and reabsorption is disrupted-often due to various pathogenic mechanisms-it can lead to pleural effusion. In such cases, effective management is essential. This study aims to conduct a thorough comparison of the two talc administration methods-TS and TI-using sterilized, large-particle, asbestos-free talc powder. By examining key outcome measures such as pleurodesis success rates, procedural morbidity, and length of hospital stay, the goal is to provide clinicians with evidence-based guidance to facilitate informed decision-making in the management of pleural effusions.
Detailed description
One of the most effective interventions for managing malignant pleural effusion (MPE) and pneumothoraces is chemical pleurodesis, which involves the introduction of a sclerosing agent into the pleural space to induce inflammation and subsequent fibrosis, thereby closing the pleural space. Among the various agents used, talc is the most widely recognized for its high success rates, affordability, and availability (3-8). There are primarily two methods of delivering talc: talc slurry (TS), which involves injecting a talc suspension via a chest tube, and talc insufflation (TI), which is performed during thoracoscopic surgery. Currently, there is no consensus on which method is superior, leading to a recommendation for individualized patient approaches that consider the specific clinical scenario and aim to minimize complications while reducing hospital stays9 .
The choice of talc particle size is critical, as it has significant implications for both the efficacy of pleurodesis and the safety of the procedure. Historically, small-particle talc formulations (less than 10 μm) have been associated with severe complications such as acute respiratory distress syndrome (ARDS) 10. This has prompted a shift toward using larger particles (greater than 15 μm), which have been shown to decrease the risk of ARDS and other respiratory complications. Importantly, studies have demonstrated that the effectiveness of pleurodesis is not compromised by the use of larger particles11.Furthermore, recommendations now advocate for the use of a minimum effective dose of talc, typically around 4-5 grams, to optimize both efficacy and safety.
Another significant advancement in the use of talc for pleurodesis is the transition to asbestos-free formulations. Historically, some talc preparations contained trace amounts of asbestos, a known carcinogen linked to serious health risks such as mesothelioma. The move toward asbestos-free talc has been driven by the need to eliminate these long-term carcinogenic risks, especially in patients who may have a prolonged survival following pleurodesis. Despite significant advancements in the use of talc pleurodesis, several important gaps remain in the literature. Notably, there is a lack of comprehensive studies focusing on the efficacy and safety of large-particle (≥15 μm), asbestos-free talc. While this formulation has been associated with a reduced risk of complications such as acute respiratory distress syndrome (ARDS), most existing research has centered on smaller-particle talc or formulations with less stringent quality controls. Furthermore, the comparative effectiveness of talc slurry (TS) and talc insufflation (TI) using modern, large-particle, asbestos-free talc is underexplored. The absence of such data hinders the development of evidence-based guidelines for selecting the optimal delivery method for individual clinical scenarios While these advancements have improved the risk-benefit profile of talc pleurodesis, it is important to recognize that the procedure is not without risks. Thus, careful patient selection and monitoring remain essential to minimize complications 12. Reducing hospital stays and procedural morbidity is critical in improving patient outcomes, especially for individuals with malignant pleural effusion (MPE) or recurrent pneumothoraces. These conditions often affect patients with advanced malignancies or significant comorbidities, where maintaining quality of life is paramount. Shorter hospital stays and fewer complications directly enhance patients' overall well-being and comfort, particularly for those with limited life expectancy. Additionally, minimizing hospital stays alleviates the economic and logistical burdens on healthcare systems, promoting the broader implementation of pleurodesis as a sustainable intervention.
International guidelines, such as those issued by the British Thoracic Society (BTS), provide valuable insights into the current standards of care for pleurodesis. These guidelines recommend talc pleurodesis as a primary intervention for symptomatic management of recurrent pleural effusions and pneumothoraces when pleural drainage alone proves insufficient. Talc remains the preferred agent due to its high efficacy and relative safety profile. However, the BTS guidelines do not strongly favor one delivery method-talc slurry or talc insufflation-over the other, advocating instead for individualized approaches based on patient needs and resource availability. The guidelines emphasize the importance of using sterilized, asbestos-free, large-particle talc to reduce the risk of complications, including ARDS and long-term carcinogenic effects13.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study will be a randomized controlled trial (RCT) to ensure robust comparisons between talc slurry (TS) and talc insufflation (TI) in managing pleural effusions or pneumothoraces. To reduce bias, the study will be single-blind, where patients will be unaware of the procedure type, while clinicians will know the intervention. This design minimizes performance and response biases without compromising the feasibility of the procedures.
| Arm | Type | Receives |
|---|---|---|
| Talc Slurry Group | Experimental | Procedure: Pleurodesispatient undergoing pleurodesis by talc slurry method are included in this group |
| Talc Insufflation Group | Experimental | Procedure: pleurodesispatient undergoing pleurodesis by talc insufflation method are included in this group |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- patients aged 12 years and older.
- Diagnosed with malignant pleural effusions or pneumothoraces.
- ECOG performance status of 0-2.
- Life expectancy of at least 3 months.
- Ability to provide informed consent.
Key exclusion criteria (6 listed)
- Patients younger than 12 years old
- Female patients who are pregnant or lactating
- Patients with encysted or septated pleural effusions and pneumothoraces
- Patients presenting with respiratory failure
- Patients complaining of dyspnea in spite of complete evacuation of pleural effusion or pneumothorax.
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 |
|---|---|---|
| PleurodesisTalc slurry pleurodesis is a chemical technique for managing recurrent pleural effusions and pneumothoraces. The procedure involves instilling a suspension of talc (4-5 grams) in sterile saline (50-100 mL) into the pleural space via a chest tube. This induces an inflammatory reaction, leading to fibrosis and fusion of pleural surfaces. The technique demonstrates 70-90% success rates in malignant pleural effusions and pneumothoraces, with efficacy comparable to talc poudrage. While generally safe, potential complications include pain, fever, and rarely, pneumonitis or empyema. Use of large-particle, asbestos-free talc and standardized protocols has improved its safety profile. | Procedure or surgery | Talc Slurry Group |
| pleurodesisTalc insufflation, is a pleurodesis technique involving direct insufflation of dry talc powder into the pleural cavity during thoracoscopy. It allows visual inspection of the pleural space and concurrent diagnostic procedures. Success rates range from 85% to 93% for malignant pleural effusions and pneumothoraces, with efficacy comparable or potentially superior to talc slurry in some studies. The procedure typically requires general anesthesia and is more invasive than talc slurry. Common side effects include chest pain, fever, and dyspnea. The risk of severe respiratory complications has decreased with large-particle, asbestos-free talc. While effective, the choice between insufflation and slurry depends on patient factors, institutional expertise, and resource availability. | Procedure or surgery | Talc Insufflation Group |
Primary outcome
Success of Pleurodesis
Time frame: 01 months post-procedure
The success rate of pleurodesis is defined as the percentage of patients who achieve complete resolution of pleural effusion or pneumothorax within a specified time frame of 01 months post-procedure. Success is assessed through follow-up chest radiographs, with criteria for success including the absence of fluid reaccumulation or lung collapse during this period. Clinical improvement in symptoms such as dyspnea may also be considered as supplementary evidence of a successful outcome.
1 secondary outcome
Procedural Morbidity of pleurodesis
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
Related trials for Pneumothorax Spontaneous Primary
Active, not recruiting
Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study
Pneumothorax Spontaneous Primary
Enrolling by invitation
Evaluating the Use of an App in Pleural Disease: Algorithm-supported Clinical Decision Making Versus Usual Care
Pleural Diseases, Pneumothorax Spontaneous Primary
Not yet recruiting
Conservative Management in Primary Spontaneous Pneumothorax: a Multicenter Randomized Non-inferiority Study
Primary Spontaneous Pneumothorax (PSP), Conservative Management (Active Observation)
Not yet recruiting
Impact of Ambulatory Management for Primary Spontaneous Pneumothorax in the Emergency Department on Quality of Life
Primary Spontaneous Pneumothorax, Quality of Life
Recruiting
Early Chest Tube Removal After Surgery for Primary Spontaneous Pneumothorax: A Randomized Controlled Trial
Primary Spontaneous Pneumothorax
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.
Muhammad Shoaib Nabi, Professor of Thoracic Surgery study chair
Services institute of Medical Sciences (SIMS), Services Hospital Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pleurodesis in people with Pneumothorax Spontaneous Primary and Pneumothorax Spontaneous Secondary, run by University of Health Sciences Lahore at 1 site in Pakistan.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 Jan 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeeshan Sarwar (+92 3214347410, zeeshan.sarwar195@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of Pleurodesis (time frame: 01 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2026.