Pneumothorax Spontaneous SecondaryPhase 2/3STOPNCT06883188
Stop Air Leak by Talc or Autologous Blood Patch Therapy
A Phase 2/3 study testing talc powder and patient's own venous blood in people with Pneumothorax Spontaneous Secondary, run by Chinese University of Hong Kong.
Trial summary
Background: A pilot study to assess the feasibility of a randomisation trial protocol comparing intrapleural talc pleurodesis versus autologous blood patch therapy (ABPT) in patients with secondary spontaneous pneumothorax (SSP) complicated by persistent air leak (PAL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax Spontaneous Secondary
- What is being tested?
- talc powder and patient's own venous blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 30 Apr 2030
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Radiographically proven pneumothorax and underlying lung disease (either pre-existing or shown in diagnostic imaging at presentation)
- Spontaneous onset of pneumothorax, not related to trauma or iatrogenic procedure
- SSP with air leak persists for at least 2 days after the first radiographic evidence of pneumothorax
- Not suitable, as decided by the attending medical or surgical team, or the patient is unwilling to receive surgical management for the pneumothorax
Who cannot join
- Inability to give informed consent
- A chest drain size smaller than Fr 12
- Bilateral pneumothorax.
- Impaired blood clotting, including baseline INR > 1.5, platelet < 150 x 109/L, or use of therapeutic dose anticoagulant or dual-antiplatelet agents.
- Active or recent (within 6 weeks) ipsilateral pleural infection.
- Septicemia or active extra-pleural infection (e.g. pneumonia).
Show all 13Show fewer
- Use of long-term systemic corticosteroids or immunosuppressant.
- Previously received talc or ABPT to the ipsilateral pleural space for the current episode of pneumothorax.
- Known sensitivity to talc.
- Has had a previous pneumonectomy (either on the same or contralateral side).
- Patients who are pregnant or lactating (females of childbearing potential must have a negative pregnancy test before randomisation).
- Expected survival of less than three months from a different pathology to the current episode of pneumothorax (e.g. metastatic malignancy).
- Cognitively impaired patients who are at risk of self-removing the chest drain
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Stop Air Leak by Talc or Autologous Blood Patch Therapy for Persistent Air Leak in Secondary Spontaneous Pneumothorax (STOP Trial): A Pilot Randomised Trial
Background: A pilot study to assess the feasibility of a randomisation trial protocol comparing intrapleural talc pleurodesis versus autologous blood patch therapy (ABPT) in patients with secondary spontaneous pneumothorax (SSP) complicated by persistent air leak (PAL). The investigators hypothesise that the proposed protocol will be feasible.
Methods: A multicentre, two-arm, open-label, randomised controlled feasibility study which includes non-surgical subjects with SSP and PAL persisting for 3 days. Recruited subjects will be randomised in a 1:1 ratio to receive one dose of talc pleurodesis or ABPT, with follow-ups up to 3 months after hospital discharge.
Discussion: The main outcome is to assess the feasibility of the trial protocol, based on the percentage of eligible patients enrolled and randomised, retained to discharge, and completing 3 months of follow-up. Other important outcomes include complete cessation of air leak and successful chest drain removal within 72 hours after the study intervention, absolute and percentage changes in digitally measured air leak rates, duration of chest drainage, recurrence of ipsilateral pneumothorax, need for additional pleural interventions, safety outcomes such as drain blockage and pleural infection. Feasibility outcomes will be reported as descriptive data. Comparison of outcomes between the two treatment groups will be analysed on an intention-to-treat basis. Safety outcomes will be reported descriptively for each group. The reported estimates of recruitment rates, adherence, follow-up completeness, and variability and event rates for key clinical outcomes will be used to inform sample size calculations for future studies incorporating the current study design.
Read the detailed description
Pneumothorax, defined as the presence of air in the pleural space, is a common respiratory emergency that often necessitates prolonged hospitalisation. In cases where pneumothorax occurs in the setting of underlying chronic lung diseases (secondary spontaneous pneumothorax, SSP), the clinical course is considerably more severe. SSP patients are typically more hypoxic, more likely to develop persistent air leak (PAL), and experience longer hospital stays with higher in-patient mortality compared to those with primary spontaneous pneumothorax (PSP).
The management of SSP with PAL remains controversial despite its clinical significance. Numerous strategies, including chemical pleurodesis, autologous blood patch therapy (ABPT), implantation of endobronchial valves (EBV), and surgical pleurodesis, are employed in practice. However, many SSP patients are unsuitable for invasive procedures such as EBV placement or surgery, owing to their poor premorbid status. In this context, ABPT and chemical pleurodesis (often using talc) emerge as low-cost, bedside alternatives. Yet, current practices vary widely, and a lack of robust comparative evidence has left clinicians with no definitive guidance regarding the optimal management approach.
Talc pleurodesis, involving the intrapleural instillation of sterile talc powder, is a commonly adopted treatment for SSP with PAL in Hong Kong. Retrospective studies indicate that 37% to 45% of SSP patients undergo chemical pleurodesis, with talc being the predominant agent. Reported treatment success is around 70%, with a median drainage duration of 12 days post-procedure. Adverse events, most notably chest pain affecting roughly one-third of patients, are not uncommon, although more serious complications such as respiratory distress occur in only 1.6% of cases. Nonetheless, these findings are derived from studies with retrospective designs and variable methodologies, limiting firm conclusions on efficacy and safety.
In contrast, ABPT has been proposed as a promising alternative for managing PAL. This technique involves the intrapleural instillation of autologous blood with the aim of sealing the air leak, initially developed for PAL in post-operative pneumothorax. Several small-scale retrospective and prospective studies have suggested that ABPT can achieve cessation in 26% to 91% of cases, with some reports showing 72% to 84% of patients experiencing complete resolution within five days. Moreover, ABPT appears safe for repeated administration, with adverse events reported at incidences ranging from 0% to 16%. However, the heterogeneous outcomes likely reflect differences in blood dosage, timing of intervention, number of administrations, and varying definitions of PAL among studies.
Given the controversy and the limitations of existing evidence, a multicentre randomised controlled trial (RCT) comparing talc pleurodesis with ABPT is imperative. To achieve this, a pilot study is designed to rigorously address methodological weaknesses by standardising the timing of pleural interventions, employing a digital chest drain system for precise, quantitative measurement of air leak, and adopting unified criteria for treatment success.
- Conditions
- Pneumothorax Spontaneous Secondary
- Being tested
- talc powder, patient's own venous blood
- Keywords
- Persistent air leak, talc pleurodesis, autologous blood patch therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
talc powderDrug
intrapleural instillation of talc slurry
patient's own venous bloodBiological
intrapleural instillation of patient's own venous blood
| Study group | Role | What they receive |
|---|---|---|
| talc pleurodesis | Experimental | intrapleural instillation of talc slurry Receives: Drug: talc powder |
| Autolougs blood patch therapy (ABPT) | Active comparator | intrapleural instillation of patient's venous blood Receives: Biological: patient's own venous blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of pilot study trial protocol including the following criteria
Study feasibility based on recruitment rate (number of eligible patients enrolled and successfully randomised), adherence rate (to the allocated study intervention) and retention rate (completed 3 months of follow-up)
Measured: 3 months
Secondary outcomes (12)
Complete cessation of air leak
Complete cessation of air leak for more than 24 hours and successful chest drain removal
Measured: 72 hours
Change in air leak
Absolute reduction and percentage change in the average rate of air leak (in mL/min) from randomisation to 72 hours after the study interventions
Measured: 72 hours
Time to air leak cessation
Time from study intervention to complete cessation of air leak and successful removal of all chest drain(s) (in hours)
Measured: 3 months
Length of acute hospital stay
Length of hospital stay after study intervention (in days)
Measured: 3 months
Need for additional (unplanned or elective) intervention for persistent air leak
The need for additional (unplanned or elective) interventions for persistent air leak, which includes needle aspiration, chest drain insertion, implantation of endobronchial valve, surgery
Measured: 3 months
Recurrence of ipsilateral pneumothorax
Recurrence of ipsilateral pneumothorax after study intervention
Measured: 3 months
Changes in inflammatory markers
Changes in inflammatory markers, including white blood cells and C-reactive protein
Measured: 3 months
Breathlessness score
Breathlessness by visual analogue scale, score ranges from 0 to 100, with 0 means no breathlessness, and 100 means the worst breathlessness ever
Measured: 3 months
Pain score
Pain score in visual analogue scale, score ranges from 0 to 10, with 0 means no pain, and 10 means the worst pain ever
Measured: 3 months
Occurrence of complications
Occurrence of complications, including chest drain blockage, dislodgement, fever, pleural infection / empyema, acute respiratory distress syndrome (ARDS)
Measured: 3 months
Protocol adherence
The reason and frequency of protocol violation throughout the study period
Measured: 3 months
Adverse events
Incidence, severity, and timing of adverse events (AEs) and serious adverse events (SAEs)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Dec 2026 (estimated)
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumothorax Spontaneous SecondaryStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multi-centre, two-arm, open-label, randomized controlled trial including patients with spontaneous secondary pneumothorax and persistent air leak. Eligible patients will be randomised in a 1:1 ratio to receive either intrapleural administration of talc or autologous blood patch therapy. The digitalised air leak rate will be monitored continuously from randomisation till the removal of chest drain. The main outcome is the feasibility of the trial protocol, based on the percentage of eligible patients being successfully enrolled and randomised, percentage of adherence to the allocated study intervention, and percentage of randomised participants completing the 3-month follow-up.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Elizabeth Hospital, Hong Kong, Princess Margaret Hospital, Hong Kong, Pamela Youde Nethersole Eastern Hospital
- Responsible party
- Principal investigator, Ka Pang Chan, Chinese University of Hong Kong
- Investigators
- David SC Hui, MD, Study director, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883188
- Sponsor's protocol ID
- STOP
- Acronym
- STOP
- Status last verified
- Oct 2026
- First submitted
- 8 Mar 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stop Air Leak by Talc or Autologous Blood Patch Therapy for Persistent Air Leak in Secondary Spontaneous Pneumothorax (STOP Trial): A Pilot Randomised Trial
- ClinicalTrials.gov ID
- NCT06883188
- Acronym / sponsor ID
- STOP / STOP
- Conditions
- Pneumothorax Spontaneous Secondary
- Keywords
- Persistent air leak, talc pleurodesis, autologous blood patch therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Elizabeth Hospital, Hong Kong, Princess Margaret Hospital, Hong Kong, Pamela Youde Nethersole Eastern Hospital
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 19 Mar 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.
Background: A pilot study to assess the feasibility of a randomisation trial protocol comparing intrapleural talc pleurodesis versus autologous blood patch therapy (ABPT) in patients with secondary spontaneous pneumothorax (SSP) complicated by persistent air leak (PAL). The investigators hypothesise that the proposed protocol will be feasible.
Methods: A multicentre, two-arm, open-label, randomised controlled feasibility study which includes non-surgical subjects with SSP and PAL persisting for 3 days. Recruited subjects will be randomised in a 1:1 ratio to receive one dose of talc pleurodesis or ABPT, with follow-ups up to 3 months after hospital discharge.
Discussion: The main outcome is to assess the feasibility of the trial protocol, based on the percentage of eligible patients enrolled and randomised, retained to discharge, and completing 3 months of follow-up. Other important outcomes include complete cessation of air leak and successful chest drain removal within 72 hours after the study intervention, absolute and percentage changes in digitally measured air leak rates, duration of chest drainage, recurrence of ipsilateral pneumothorax, need for additional pleural interventions, safety outcomes such as drain blockage and pleural infection. Feasibility outcomes will be reported as descriptive data. Comparison of outcomes between the two treatment groups will be analysed on an intention-to-treat basis. Safety outcomes will be reported descriptively for each group. The reported estimates of recruitment rates, adherence, follow-up completeness, and variability and event rates for key clinical outcomes will be used to inform sample size calculations for future studies incorporating the current study design.
Detailed description
Pneumothorax, defined as the presence of air in the pleural space, is a common respiratory emergency that often necessitates prolonged hospitalisation. In cases where pneumothorax occurs in the setting of underlying chronic lung diseases (secondary spontaneous pneumothorax, SSP), the clinical course is considerably more severe. SSP patients are typically more hypoxic, more likely to develop persistent air leak (PAL), and experience longer hospital stays with higher in-patient mortality compared to those with primary spontaneous pneumothorax (PSP).
The management of SSP with PAL remains controversial despite its clinical significance. Numerous strategies, including chemical pleurodesis, autologous blood patch therapy (ABPT), implantation of endobronchial valves (EBV), and surgical pleurodesis, are employed in practice. However, many SSP patients are unsuitable for invasive procedures such as EBV placement or surgery, owing to their poor premorbid status. In this context, ABPT and chemical pleurodesis (often using talc) emerge as low-cost, bedside alternatives. Yet, current practices vary widely, and a lack of robust comparative evidence has left clinicians with no definitive guidance regarding the optimal management approach.
Talc pleurodesis, involving the intrapleural instillation of sterile talc powder, is a commonly adopted treatment for SSP with PAL in Hong Kong. Retrospective studies indicate that 37% to 45% of SSP patients undergo chemical pleurodesis, with talc being the predominant agent. Reported treatment success is around 70%, with a median drainage duration of 12 days post-procedure. Adverse events, most notably chest pain affecting roughly one-third of patients, are not uncommon, although more serious complications such as respiratory distress occur in only 1.6% of cases. Nonetheless, these findings are derived from studies with retrospective designs and variable methodologies, limiting firm conclusions on efficacy and safety.
In contrast, ABPT has been proposed as a promising alternative for managing PAL. This technique involves the intrapleural instillation of autologous blood with the aim of sealing the air leak, initially developed for PAL in post-operative pneumothorax. Several small-scale retrospective and prospective studies have suggested that ABPT can achieve cessation in 26% to 91% of cases, with some reports showing 72% to 84% of patients experiencing complete resolution within five days. Moreover, ABPT appears safe for repeated administration, with adverse events reported at incidences ranging from 0% to 16%. However, the heterogeneous outcomes likely reflect differences in blood dosage, timing of intervention, number of administrations, and varying definitions of PAL among studies.
Given the controversy and the limitations of existing evidence, a multicentre randomised controlled trial (RCT) comparing talc pleurodesis with ABPT is imperative. To achieve this, a pilot study is designed to rigorously address methodological weaknesses by standardising the timing of pleural interventions, employing a digital chest drain system for precise, quantitative measurement of air leak, and adopting unified criteria for treatment success.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multi-centre, two-arm, open-label, randomized controlled trial including patients with spontaneous secondary pneumothorax and persistent air leak. Eligible patients will be randomised in a 1:1 ratio to receive either intrapleural administration of talc or autologous blood patch therapy. The digitalised air leak rate will be monitored continuously from randomisation till the removal of chest drain. The main outcome is the feasibility of the trial protocol, based on the percentage of eligible patients being successfully enrolled and randomised, percentage of adherence to the allocated study intervention, and percentage of randomised participants completing the 3-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| talc pleurodesis | Experimental | Drug: talc powderintrapleural instillation of talc slurry |
| Autolougs blood patch therapy (ABPT) | Active comparator | Biological: patient's own venous bloodintrapleural instillation of patient's venous blood |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Radiographically proven pneumothorax and underlying lung disease (either pre-existing or shown in diagnostic imaging at presentation)
- Spontaneous onset of pneumothorax, not related to trauma or iatrogenic procedure
- SSP with air leak persists for at least 2 days after the first radiographic evidence of pneumothorax
- Not suitable, as decided by the attending medical or surgical team, or the patient is unwilling to receive surgical management for the pneumothorax
Key exclusion criteria (13 listed)
- Inability to give informed consent
- A chest drain size smaller than Fr 12
- Bilateral pneumothorax.
- Impaired blood clotting, including baseline INR > 1.5, platelet < 150 x 109/L, or use of therapeutic dose anticoagulant or dual-antiplatelet agents.
- Active or recent (within 6 weeks) ipsilateral pleural infection.
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 |
|---|---|---|
| talc powderintrapleural instillation of talc slurry | Drug | talc pleurodesis |
| patient's own venous bloodintrapleural instillation of patient's own venous blood | Biological | Autolougs blood patch therapy (ABPT) |
Primary outcome
Feasibility of pilot study trial protocol including the following criteria
Time frame: 3 months
Study feasibility based on recruitment rate (number of eligible patients enrolled and successfully randomised), adherence rate (to the allocated study intervention) and retention rate (completed 3 months of follow-up)
12 secondary outcomes
Complete cessation of air leak
Time frame: 72 hours
Change in air leak
Time frame: 72 hours
Time to air leak cessation
Time frame: 3 months
Length of acute hospital stay
Time frame: 3 months
Need for additional (unplanned or elective) intervention for persistent air leak
Time frame: 3 months
Recurrence of ipsilateral pneumothorax
Time frame: 3 months
Changes in inflammatory markers
Time frame: 3 months
Breathlessness score
Time frame: 3 months
Pain score
Time frame: 3 months
Occurrence of complications
Time frame: 3 months
Protocol adherence
Time frame: 3 months
Adverse events
Time frame: 3 months
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 26 Oct 2026.
- Individual participant dataSharing planned: No
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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.
David SC Hui, MD study director
Chinese University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing talc powder and patient's own venous blood in people with Pneumothorax Spontaneous Secondary, run by Chinese University of Hong Kong.
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 5 inclusion and 13 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ka Pang Chan, MBChB (+852 3505 2211, chankapang@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of pilot study trial protocol including the following criteria (time frame: 3 months). 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 26 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.