Malignant Pleural EffusionAMPLE-3NCT04322136
AMPLE-3: IPC Plus Talc vs VATS in Management of Malignant Pleural Effusion
A study testing Pleurodesis via Video-assisted thoracoscopic surgery and Indwelling pleural catheter (with talc pleurodesis if suitable) in people with Malignant Pleural Effusion and Respiratory Disease, run by The University of Western Australia at 1 site in Australia.
Trial summary
The purpose of this study is to determine if an indwelling catheter is more effective than surgical pleurodosis in treating malignant pleural effusion. Who is it for? You may be eligible for this study if you are an adult who is suffering from symptomatic proven pleural malignancy or an otherwise unexplained pleural… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Effusion, Respiratory Disease, Cancer
- What is being tested?
- Pleurodesis via Video-assisted thoracoscopic surgery and Indwelling pleural catheter (with talc pleurodesis if suitable)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteAustralia
- Study dates
- 29 May 2018to 7 Aug 2025
- 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
- Patients with a symptomatic MPE*
- Predicted survival of more than 6 months
- Eastern Cooperative Oncology Group (ECOG) score = Peformance status defined as a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc. ECOG 0-1 (or ECOG greater than or equal to 2 if it is felt that removal of pleural fluid would improve their status to 0 or 1).
- MPE is defined as histologically/cytologically proven pleural malignancy or an otherwise unexplained pleural effusion in the context of clinically proven cancer elsewhere.
Who cannot join
- Age <18yrs;
- Unfit to undergo a surgical procedure (American Society of Anaesthesiologists Score >/=4); 3. Pleural infection;
- 4. Chylothorax; 5. Pregnancy or lactation; 6. Uncorrectable bleeding diathesis; 7. Previous ipsilateral lobectomy/pneumonectomy; 8. Inability to consent or comply with protocol.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Institute for Respiratory Health
Nedlands, Western Australia, 6009
About this study
Official title: The Australasian Malignant PLeural Effusion (AMPLE) Trial - 3: A Randomised Study of the Relative Benefits of Combined Indwelling Pleural Catheter (IPC) and Talc Pleurodesis Therapy or Video-Assisted Thoracoscopic Surgery (VATS) in the Management of Patients With Malignant Pleural Effusion.
The purpose of this study is to determine if an indwelling catheter is more effective than surgical pleurodosis in treating malignant pleural effusion.
Who is it for?
Read more
You may be eligible for this study if you are an adult who is suffering from symptomatic proven pleural malignancy or an otherwise unexplained pleural effusion.
Study details
Consenting participants will be randomised to one of two treatment arms:
- Arm 1: Indwelling pleural catheter. A long term catheter is inserted under the skin in order to allow ongoing drainage of the pleural fluid. Participants will then be instructed to undergo a daily drainage regimen for 14 days at home.
- Arm 2: Surgical pleurodesis. Participants under a key-hole surgery to remove fluid and facilitate lung re-expansion.
Participants will then be followed up at discharge, 14 days, monthly for 6 months and then every 3 months up to one year post-procedure. These visits will include completion of Quality of Life questionnaires, a chest xray, an ultrasound (if thought necessary) and if you are at the lead site (Sir Charles Gairdner Hospital) a review of your Actigraphy logs up to 6 months after discharge.
It is hoped this research will help to provide effective symptom control with minimal intervention for those with malignant pleural effusion.
Read the detailed description
Participants will be randomly assigned (1:1) to one of two arms:
Arm 1: Indwelling pleural catheter (with talc pleurodesis if suitable) Arm 2: Pleurodesis via Video-assisted thoracoscopic surgery
Arm 1: Indwelling pleural catheter is a long-term catheter that is tunnelled under the skin and allows ongoing drainage of pleural fluid by the patient or carer at home. It is inserted using local anaesthetic with or without sedation depending on local practice. An experienced respiratory physician inserts the catheter. Once the catheter is inserted, the pleural fluid will be evacuated as completely as possible. If the lung fully re-expands and there is no contraindication to talc pleurodesis, 4-5g of sterile graded talc will be instilled via the IPC. The participant will then be discharged on a daily drainage regimen for 14 days. The drainage will either be performed by the participant's carer or nurses in the community. A bottle or bag will be attached to the drain to allow for removal of accumulated pleural fluid. Once completed the drain will be reattached to the pleural catheter. At review in clinic on day 14 (+/- 2 days), the participant will be assessed for spontaneous pleurodesis (<50ml drainage on 3 consecutive drainage attempts). If pleurodesis has occurred and there is no residual symptomatic effusion, arrangements will be made for IPC removal. Otherwise the participant will switch to a symptom-guided drainage regimen. If the lung does not fully re-expand following complete fluid evacuation, they will be discharged on a symptom-guided regimen without instillation of talc. The drainage regimen will continue for the duration of the study and beyond if pleurodesis has not occurred and pleural fluid continues to accumulate. All participants will remain under the care of their study doctors who are also their usual physicians, after the end of the study.
Arm 2: Video-assisted thoracoscopic surgery is a type of key-hole surgery performed under general anaesthetic and usually single lung ventilation by a cardio-thoracic surgeon. This is expected to take about 1 hour. Between one and three ports are used to insert a camera and instruments into the chest cavity. Adhesions can be broken down if present and the lining of the lung (visceral pleura) can sometimes be removed (decortication) to facilitate lung re-expansion. The surgeon can then perform either mechanical abrasion or talc poudrage to induce inflammation and subsequent pleurodesis. A chest drain is left in situ post-operatively and is removed when the fluid draining is below a certain volume depending on local practice.
Participants in both arms will be reviewed at the same time points - at discharge, 14 days post-procedure, monthly to 6 months, then 3-monthly to 1 year. The reviews will include quality of life and breathlessness questionnaires.
All data will be obtained by the designated study research team who will carry out the IPC insertions and where VATs pleurodesis is undertaken, the research team will liaise directly with the study surgeon.
- Conditions
- Malignant Pleural Effusion, Respiratory Disease, Cancer
- Being tested
- Pleurodesis via Video-assisted thoracoscopic surgery, Indwelling pleural catheter (with talc pleurodesis if suitable)
- Medical subject headings
- Pleural Effusion, Malignant, Respiration Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleurodesis via Video-assisted thoracoscopic surgeryProcedure or surgery
Video-assisted thoracoscopic surgery is a type of key-hole surgery performed under general anaesthetic and usually single lung ventilation by a cardio-thoracic surgeon. This is expected to take about 1 hour. Between one and three ports are used to insert a camera and instruments into the chest cavity. Adhesions can be broken down if present and the lining of the lung (visceral pleura) can sometimes be removed (decortication) to facilitate lung re-expansion. The surgeon can then perform either mechanical abrasion or talc poudrage to induce inflammation and subsequent pleurodesis. A chest drain is left in situ post-operatively and is removed when the fluid draining is below a certain volume depending on local practice.
Indwelling pleural catheter (with talc pleurodesis if suitable)Device
Once the indwelling pleural catheter is inserted, the pleural fluid will be evacuated as completely as possible. If the lung fully re-expands, 4-5g of sterile graded talc will be instilled via the IPC. The participant will then be discharged on a daily drainage regimen for 14 days. At review in clinic on day 14, the participant will be assessed for spontaneous pleurodesis (<50ml drainage on 3 consecutive drainage attempts). If pleurodesis has occurred and there is no residual symptomatic effusion, arrangements will be made for IPC removal. Otherwise the participant will switch to a symptom-guided drainage regimen. If the lung does not fully re-expand following complete fluid evacuation, they will be discharged on a symptom-guided regimen without instillation of talc. The drainage regimen will continue for the duration of the study and beyond if pleurodesis has not occurred and pleural fluid continues to accumulate.
| Study group | Role | What they receive |
|---|---|---|
| IPC (with talc pleurodesis if suitable) | Other | The patients will undertake daily drainage to day 14 post insertion. The drainage will either be performed by the participant's carer or nurses in the community. A bottle or bag will be attached to the drain to allow for removal of accumulated pleural fluid. Once completed the drain will be reattached to the pleural catheter.
Participants will be taught how to perform pleural drainage by the main study doctor at the hospital or a specialist nurse. They will drain their own IPCs at home with the either the help of a family member or friend or have access to community nursing support systems. Receives: Device: Indwelling pleural catheter (with talc pleurodesis if suitable) |
| Pleurodesis via VATS | Other | Participants will undergo VATS within two weeks of randomisation. VATS is usually performed in an operating theatre, using either general anaesthesia or local anaesthesia with sedation. The pleural fluid will be removed and adhesions can be divided (adhesiolysis). Assessment of lung re-expansion will be performed intra-operatively. If lung re-expansion is adequate (as judged by the operating surgeon), a variety of techniques may be employed to induce a pleurodesis, including, but not limited to, talc poudrage and mechanical abrasion. Decortication may be performed if deemed appropriate and feasible by the operating surgeon. A chest drain will be left in situ after the surgery. Post-operative care will be administered as per local practice. Receives: Procedure: Pleurodesis via Video-assisted thoracoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for an ipsilateral pleural intervention
Proportion of participants requiring an ipsilateral (on the same side) pleural procedure for management of symptomatic re-accumulation of pleural fluid including surgical procedure, chest drain insertion, attempted therapeutic thoracentesis. This is a composite outcome.
Data will be obtained from the participants and the hospital record.
Measured: Participants will be followed for a maximum of 12 months or until death if sooner.
Secondary outcomes (10)
Need for repeat ipsilateral pleural intervention including diagnostic aspiration
Proportion of participants requiring an ipsilateral pleural procedure including diagnostic aspirate.
Data will be obtained from the participants and the hospital record.
Measured: The study is for 12 months or until death if prior.
Time to symptomatic effusion recurrence
Time to effusion recurrence - will be assessed using chest x-ray and ultrasound at each visit. Recurrent effusion is defined as greater than 25% opacity on chest x-ray on the side of the intervention as judged by two independent clinicians and evidence of pleural fluid on ultrasound.
Measured: The study is for 12 months or until death if prior.
All-cause hospital days
Length of stay post-procedure and hospitalization for any cause (except for elective admissions for chemotherapy) will be recorded for all patients post randomisation. Admissions will be analysed as total admission days and also pleural-related admission days.
The data will be collected from participants and the hospital records.
Measured: The study is for 12 months or until death if prior.
Degree of breathlessness
Degree of breathlessness will be measured by a 100mm Visual Analogue Scale (VAS). The VAS is a 100mm line anchored with "no breathlessness" at 0mm and "worst breathlessness imaginable" at 100mm.
Measured: Scores will be recorded daily for 28 days, then monthly to 6 months and 3-monthly until 12 months.
Pain scale
Pain will be assessed using a 100mm visual analogue scale. The 100mm horizontal line will be anchored with "no pain" at 0mm and "worst pain imaginable" at 100mm.
Measured: Scores will be recorded daily for 28 days, monthly to 6 months and then 3-monthly to 12 months
Quality of Life (QoL)
Quality of Life (QoL) will be measured using two instruments: EQ-5D-5L is a standardised measure of HRQoL that comprises five dimensions including mobility, self-care, usual activities, pain//discomfort and anxiety/depression. VAS QoL records self-rated health on a 100mm line anchored with "best imaginable health state" at 0mm and "worst imaginable health state" at 100mm.
Measured: QoL will be measured at baseline, day 7-10 post-procedure, then monthly to 6 months then 3 monthly to 12 months.
Physical activity patterns
Actigraphy is one part of the study and is an outcome comprising a few different factors. Physical activity patterns, vigorous activity and periods of sedentary behaviour, will be evaluated by a well validated triaxial accelerometer (ActiGraph GT3X+, Pensacola, FL, USA). Objective physical activity patterns will be assessed by 7-day triaxial accelerometer assessment providing an indication of functional status. The Actigraph device is reliable, with excellent test-retest reproducibility in cancer research and rated as 'user friendly' by both healthy and patient populations.
Measured: Monthly to 12 months at lead site only.
Adverse events from time of enrolment
Adverse events from randomization until end of follow-up or death. An adverse event is defined as any participant-reported or medical records complications associated with the IPC or VATS pleurodesis, such as pleural infection, cellulitis, pain, symptomatic loculation, tube blockage, catheter tract metastases, parenchymal air leak etc., and any peri/post-procedural complications such as prolonged air-leak, atelectasis, pneumonia, cardiovascular complications, acute kidney injury or drop in haemoglobin requiring transfusion.
Measured: Assessed continuously up to 12 months.
Overall survival from randomisation.
Overall Survival will be recorded from date of enrolment to death or end of study follow-up. Survival difference between IPC and VATS management of malignant pleural effusion has not been previously studied.
Measured: From randomisation up to 12 months
Pleural-related hospital days.
Pleural-related hospital days. Length of stay post-procedure and hospitalization for any cause (except for elective admissions for chemotherapy) will be recorded for all patients post randomisation. Admissions will be analysed as total admission days and also pleural-related admission days.
The data will be collected from participants and the hospital records.
Measured: The study is for 12 months or until death if prior.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start29 May 2018
- Primary completion7 Aug 2025
- Study completion7 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural EffusionStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Western Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Charles Gairdner Hospital, Fiona Stanley Hospital, The Sutherland and St George Hospitals, Australia, Hollywood Private Hospital, Australia, Wellington Hospital, Northern Hospital, Australia, Concord Hospital, Royal Adelaide Hospital, St John of God Midland Hospital, Australia, St John of God Murdoch Hospital, Australia, Westmead Hospital, St Vincent's Hospital Melbourne, The Prince Charles Hospital, Sunshine Coast Hospital and Health Service, Guy's and St Thomas' NHS Foundation Trust, Toronto General Hospital, Universiti Kebangsaan Malaysia Medical Centre, Hospital Queen Elizabeth, Malaysia, Johns Hopkins University, John Hunter Hospital, Wesley Hospital, Australia, Auckland City Hospital, Vanderbilt University Medical Center
- Responsible party
- Principal investigator, YC Gary Lee, The University of Western Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322136
- Sponsor's protocol ID
- AMPLE-3
- Other IDs
- ACTRN12618001013257
- Acronym
- AMPLE-3
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2020
- Last updated
- 5 May 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Australasian Malignant PLeural Effusion (AMPLE) Trial - 3: A Randomised Study of the Relative Benefits of Combined Indwelling Pleural Catheter (IPC) and Talc Pleurodesis Therapy or Video-Assisted Thoracoscopic Surgery (VATS) in the Management of Patients With Malignant Pleural Effusion.
- ClinicalTrials.gov ID
- NCT04322136
- Acronym / sponsor ID
- AMPLE-3 / AMPLE-3
- Conditions
- Malignant Pleural Effusion, Respiratory Disease, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- The University of Western AustraliaUniversity, hospital or other
- Collaborators
- Sir Charles Gairdner Hospital, Fiona Stanley Hospital, The Sutherland and St George Hospitals, Australia, Hollywood Private Hospital, Australia, Wellington Hospital, Northern Hospital, Australia, Concord Hospital, Royal Adelaide Hospital, St John of God Midland Hospital, Australia, St John of God Murdoch Hospital, Australia, Westmead Hospital, St Vincent's Hospital Melbourne, The Prince Charles Hospital, Sunshine Coast Hospital and Health Service, Guy's and St Thomas' NHS Foundation Trust, Toronto General Hospital, Universiti Kebangsaan Malaysia Medical Centre, Hospital Queen Elizabeth, Malaysia, Johns Hopkins University, John Hunter Hospital, Wesley Hospital, Australia, Auckland City Hospital, Vanderbilt University Medical Center
- Study start
- 29 May 2018 (actual)
- Primary completion
- 7 Aug 2025 (actual)
- Study completion
- 7 Aug 2025 (actual)
- First posted
- 26 Mar 2020 (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 purpose of this study is to determine if an indwelling catheter is more effective than surgical pleurodosis in treating malignant pleural effusion.
Who is it for?
You may be eligible for this study if you are an adult who is suffering from symptomatic proven pleural malignancy or an otherwise unexplained pleural effusion.
Study details
Consenting participants will be randomised to one of two treatment arms:
- Arm 1: Indwelling pleural catheter. A long term catheter is inserted under the skin in order to allow ongoing drainage of the pleural fluid. Participants will then be instructed to undergo a daily drainage regimen for 14 days at home.
- Arm 2: Surgical pleurodesis. Participants under a key-hole surgery to remove fluid and facilitate lung re-expansion.
Participants will then be followed up at discharge, 14 days, monthly for 6 months and then every 3 months up to one year post-procedure. These visits will include completion of Quality of Life questionnaires, a chest xray, an ultrasound (if thought necessary) and if you are at the lead site (Sir Charles Gairdner Hospital) a review of your Actigraphy logs up to 6 months after discharge.
It is hoped this research will help to provide effective symptom control with minimal intervention for those with malignant pleural effusion.
Detailed description
Participants will be randomly assigned (1:1) to one of two arms:
Arm 1: Indwelling pleural catheter (with talc pleurodesis if suitable) Arm 2: Pleurodesis via Video-assisted thoracoscopic surgery
Arm 1: Indwelling pleural catheter is a long-term catheter that is tunnelled under the skin and allows ongoing drainage of pleural fluid by the patient or carer at home. It is inserted using local anaesthetic with or without sedation depending on local practice. An experienced respiratory physician inserts the catheter. Once the catheter is inserted, the pleural fluid will be evacuated as completely as possible. If the lung fully re-expands and there is no contraindication to talc pleurodesis, 4-5g of sterile graded talc will be instilled via the IPC. The participant will then be discharged on a daily drainage regimen for 14 days. The drainage will either be performed by the participant's carer or nurses in the community. A bottle or bag will be attached to the drain to allow for removal of accumulated pleural fluid. Once completed the drain will be reattached to the pleural catheter. At review in clinic on day 14 (+/- 2 days), the participant will be assessed for spontaneous pleurodesis (<50ml drainage on 3 consecutive drainage attempts). If pleurodesis has occurred and there is no residual symptomatic effusion, arrangements will be made for IPC removal. Otherwise the participant will switch to a symptom-guided drainage regimen. If the lung does not fully re-expand following complete fluid evacuation, they will be discharged on a symptom-guided regimen without instillation of talc. The drainage regimen will continue for the duration of the study and beyond if pleurodesis has not occurred and pleural fluid continues to accumulate. All participants will remain under the care of their study doctors who are also their usual physicians, after the end of the study.
Arm 2: Video-assisted thoracoscopic surgery is a type of key-hole surgery performed under general anaesthetic and usually single lung ventilation by a cardio-thoracic surgeon. This is expected to take about 1 hour. Between one and three ports are used to insert a camera and instruments into the chest cavity. Adhesions can be broken down if present and the lining of the lung (visceral pleura) can sometimes be removed (decortication) to facilitate lung re-expansion. The surgeon can then perform either mechanical abrasion or talc poudrage to induce inflammation and subsequent pleurodesis. A chest drain is left in situ post-operatively and is removed when the fluid draining is below a certain volume depending on local practice.
Participants in both arms will be reviewed at the same time points - at discharge, 14 days post-procedure, monthly to 6 months, then 3-monthly to 1 year. The reviews will include quality of life and breathlessness questionnaires.
All data will be obtained by the designated study research team who will carry out the IPC insertions and where VATs pleurodesis is undertaken, the research team will liaise directly with the study surgeon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPC (with talc pleurodesis if suitable) | Other | Device: Indwelling pleural catheter (with talc pleurodesis if suitable)The patients will undertake daily drainage to day 14 post insertion. The drainage will either be performed by the participant's carer or nurses in the community. A bottle or bag will be attached to the drain to allow for removal of accumulated pleural fluid. Once completed the drain will be reattached to the pleural catheter. Participants will be taught how to perform pleural drainage by the main study doctor at the hospital or a specialist nurse. They will drain their own IPCs at home with the either the help of a family member or friend or have access to community nursing support systems. |
| Pleurodesis via VATS | Other | Procedure: Pleurodesis via Video-assisted thoracoscopic surgeryParticipants will undergo VATS within two weeks of randomisation. VATS is usually performed in an operating theatre, using either general anaesthesia or local anaesthesia with sedation. The pleural fluid will be removed and adhesions can be divided (adhesiolysis). Assessment of lung re-expansion will be performed intra-operatively. If lung re-expansion is adequate (as judged by the operating surgeon), a variety of techniques may be employed to induce a pleurodesis, including, but not limited to, talc poudrage and mechanical abrasion. Decortication may be performed if deemed appropriate and feasible by the operating surgeon. A chest drain will be left in situ after the surgery. Post-operative care will be administered as per local practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a symptomatic MPE*
- Predicted survival of more than 6 months
- Eastern Cooperative Oncology Group (ECOG) score = Peformance status defined as a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc. ECOG 0-1 (or ECOG greater than or equal to 2 if it is felt that removal of pleural fluid would improve their status to 0 or 1).
Key exclusion criteria (3 listed)
- Age <18yrs;
- Unfit to undergo a surgical procedure (American Society of Anaesthesiologists Score >/=4); 3. Pleural infection;
- 4. Chylothorax; 5. Pregnancy or lactation; 6. Uncorrectable bleeding diathesis; 7. Previous ipsilateral lobectomy/pneumonectomy; 8. Inability to consent or comply with protocol.
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 |
|---|---|---|
| Pleurodesis via Video-assisted thoracoscopic surgeryVideo-assisted thoracoscopic surgery is a type of key-hole surgery performed under general anaesthetic and usually single lung ventilation by a cardio-thoracic surgeon. This is expected to take about 1 hour. Between one and three ports are used to insert a camera and instruments into the chest cavity. Adhesions can be broken down if present and the lining of the lung (visceral pleura) can sometimes be removed (decortication) to facilitate lung re-expansion. The surgeon can then perform either mechanical abrasion or talc poudrage to induce inflammation and subsequent pleurodesis. A chest drain is left in situ post-operatively and is removed when the fluid draining is below a certain volume depending on local practice. | Procedure or surgery | Pleurodesis via VATS |
| Indwelling pleural catheter (with talc pleurodesis if suitable)Once the indwelling pleural catheter is inserted, the pleural fluid will be evacuated as completely as possible. If the lung fully re-expands, 4-5g of sterile graded talc will be instilled via the IPC. The participant will then be discharged on a daily drainage regimen for 14 days. At review in clinic on day 14, the participant will be assessed for spontaneous pleurodesis (<50ml drainage on 3 consecutive drainage attempts). If pleurodesis has occurred and there is no residual symptomatic effusion, arrangements will be made for IPC removal. Otherwise the participant will switch to a symptom-guided drainage regimen. If the lung does not fully re-expand following complete fluid evacuation, they will be discharged on a symptom-guided regimen without instillation of talc. The drainage regimen will continue for the duration of the study and beyond if pleurodesis has not occurred and pleural fluid continues to accumulate. | Device | IPC (with talc pleurodesis if suitable) |
Primary outcome
Need for an ipsilateral pleural intervention
Time frame: Participants will be followed for a maximum of 12 months or until death if sooner.
Proportion of participants requiring an ipsilateral (on the same side) pleural procedure for management of symptomatic re-accumulation of pleural fluid including surgical procedure, chest drain insertion, attempted therapeutic thoracentesis. This is a composite outcome. Data will be obtained from the participants and the hospital record.
10 secondary outcomes
Need for repeat ipsilateral pleural intervention including diagnostic aspiration
Time frame: The study is for 12 months or until death if prior.
Time to symptomatic effusion recurrence
Time frame: The study is for 12 months or until death if prior.
All-cause hospital days
Time frame: The study is for 12 months or until death if prior.
Degree of breathlessness
Time frame: Scores will be recorded daily for 28 days, then monthly to 6 months and 3-monthly until 12 months.
Pain scale
Time frame: Scores will be recorded daily for 28 days, monthly to 6 months and then 3-monthly to 12 months
Quality of Life (QoL)
Time frame: QoL will be measured at baseline, day 7-10 post-procedure, then monthly to 6 months then 3 monthly to 12 months.
Physical activity patterns
Time frame: Monthly to 12 months at lead site only.
Adverse events from time of enrolment
Time frame: Assessed continuously up to 12 months.
Overall survival from randomisation.
Time frame: From randomisation up to 12 months
Pleural-related hospital days.
Time frame: The study is for 12 months or until death if prior.
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 5 May 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. 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 Pleurodesis via Video-assisted thoracoscopic surgery and Indwelling pleural catheter (with talc pleurodesis if suitable) in people with Malignant Pleural Effusion and Respiratory Disease, run by The University of Western Australia at 1 site in Australia.
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 3 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 5 May 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 Australia. 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?
Need for an ipsilateral pleural intervention (time frame: Participants will be followed for a maximum of 12 months or until death if sooner.). 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 5 May 2026.