Recurrent Malignant Pleural Effusion.Phase 4NCT00789087
Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion
A Phase 4 study testing Videothoracoscopic talc poudrage (VT). and Talc slurry through a chest tube (DT). in people with Recurrent Malignant Pleural Effusion., run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to analyze and compare radiological lung expansion after talc pleurodesis performed either by videothoracoscopy or chest tube and correlate it with clinical outcome. Secondary endpoints evaluated were: clinical efficacy, safety, quality of life and survival. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Recurrent Malignant Pleural Effusion.
- What is being tested?
- Videothoracoscopic talc poudrage (VT). and Talc slurry through a chest tube (DT).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2005to Jan 2008
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Malignant pleural effusion confirmed by cytological analysis of pleural fluid and/or pleural biopsy;
- Recurrent pleural effusion with symptoms;
- Chest radiography with lung expansion after thoracocentesis;
- Karnofsky Performance Status > 70;
- Written informed patient consent were obtained.
Who cannot join
- Hemorrhagic diathesis;
- Active infection;
- Cutaneous infiltration;
- Patients unable to understand the questionnaires;
- Age: > 90 yo or < 18 yo.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo Medical School
São Paulo, São Paulo, 01246903
About this study
Official title: Analysis of Clinical and Radiological Results of Two Methods of Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion
The purpose of this study is to analyze and compare radiological lung expansion after talc pleurodesis performed either by videothoracoscopy or chest tube and correlate it with clinical outcome. Secondary endpoints evaluated were: clinical efficacy, safety, quality of life and survival.
Read the detailed description
Talc pleurodesis is the most popular method to control symptoms of recurrent malignant pleural effusion. The intrapleural talc delivery may be by videothoracoscopy and talc poudrage or talc slurry thought a chest tube and the best method is still controversial. Although the lung expansion is a key criteria for success of the procedure, its characteristics are poorly studied.
Patients were enrolled into two groups: videothoracoscopic talc poudrage (VT) and talc slurry through a chest tube (DT). Lung expansion was evaluated through chest CT scans obtained obtained in the first 7 days and 1, 3 and 6 months after pleurodesis. All examinations were revised by two independent observers. Clinical efficacy (considered as lack of new procedures during follow up), complications, drainage duration, hospital stay and quality of life (general and specific questionnaires) were also analyzed.
- Conditions
- Recurrent Malignant Pleural Effusion.
- Being tested
- Videothoracoscopic talc poudrage (VT)., Talc slurry through a chest tube (DT).
- Keywords
- Pleural Effusion., Talc., Pleurodesis., Quality of Life., Thoracoscopy.
- Medical subject headings
- Pleural Effusion, Malignant, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videothoracoscopic talc poudrage (VT).Procedure or surgery
Also called Videothoracoscopic talc poudrage
Videothoracoscopic talc poudrage
Talc slurry through a chest tube (DT).Procedure or surgery
Also called Talc slurry through a chest tube
Talc slurry through a chest tube
| Study group | Role | What they receive |
|---|---|---|
| 1. Videothoracoscopic talc poudrage (VT) | Active comparator | Not described Receives: Procedure: Videothoracoscopic talc poudrage (VT). |
| 2. Talc slurry through a chest tube (DT) | Active comparator | Not described Receives: Procedure: Talc slurry through a chest tube (DT). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological lung expansion after talc pleurodesis and clinical outcome
Measured: 6 months
Secondary outcomes (1)
Clinical efficacy, safety, quality of life and survival.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startJan 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Malignant Pleural Effusion.Studies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Ricardo M. Terra, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789087
- Sponsor's protocol ID
- 1105/04
- Status last verified
- Nov 2008
- First submitted
- 10 Nov 2008
- Last updated
- 11 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Terra RM, Junqueira JJM, Teixeira LR, Vargas FS, Pego-Fernandes PM, Jatene FB. Is full postpleurodesis lung expansion a determinant of a successful outcome after talc pleurodesis? Chest. 2009 Aug;136(2):361-368. doi: 10.1378/chest.08-2448. Epub 2009 Apr 6.
PubMed 19349389
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Clinical and Radiological Results of Two Methods of Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion
- ClinicalTrials.gov ID
- NCT00789087
- Acronym / sponsor ID
- 1105/04
- Conditions
- Recurrent Malignant Pleural Effusion.
- Keywords
- Pleural Effusion., Talc., Pleurodesis., Quality of Life., Thoracoscopy.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 11 Nov 2008 (estimated)
- 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 analyze and compare radiological lung expansion after talc pleurodesis performed either by videothoracoscopy or chest tube and correlate it with clinical outcome. Secondary endpoints evaluated were: clinical efficacy, safety, quality of life and survival.
Detailed description
Talc pleurodesis is the most popular method to control symptoms of recurrent malignant pleural effusion. The intrapleural talc delivery may be by videothoracoscopy and talc poudrage or talc slurry thought a chest tube and the best method is still controversial. Although the lung expansion is a key criteria for success of the procedure, its characteristics are poorly studied.
Patients were enrolled into two groups: videothoracoscopic talc poudrage (VT) and talc slurry through a chest tube (DT). Lung expansion was evaluated through chest CT scans obtained obtained in the first 7 days and 1, 3 and 6 months after pleurodesis. All examinations were revised by two independent observers. Clinical efficacy (considered as lack of new procedures during follow up), complications, drainage duration, hospital stay and quality of life (general and specific questionnaires) were also analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Videothoracoscopic talc poudrage (VT) | Active comparator | Procedure: Videothoracoscopic talc poudrage (VT). |
| 2. Talc slurry through a chest tube (DT) | Active comparator | Procedure: Talc slurry through a chest tube (DT). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Malignant pleural effusion confirmed by cytological analysis of pleural fluid and/or pleural biopsy;
- Recurrent pleural effusion with symptoms;
- Chest radiography with lung expansion after thoracocentesis;
- Karnofsky Performance Status > 70;
- Written informed patient consent were obtained.
Key exclusion criteria (5 listed)
- Hemorrhagic diathesis;
- Active infection;
- Cutaneous infiltration;
- Patients unable to understand the questionnaires;
- Age: > 90 yo or < 18 yo.
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 |
|---|---|---|
| Videothoracoscopic talc poudrage (VT).Also: Videothoracoscopic talc poudrageVideothoracoscopic talc poudrage | Procedure or surgery | 1. Videothoracoscopic talc poudrage (VT) |
| Talc slurry through a chest tube (DT).Also: Talc slurry through a chest tubeTalc slurry through a chest tube | Procedure or surgery | 2. Talc slurry through a chest tube (DT) |
Primary outcome
Radiological lung expansion after talc pleurodesis and clinical outcome
Time frame: 6 months
1 secondary outcome
Clinical efficacy, safety, quality of life and survival.
Time frame: 6 months
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 11 Nov 2008.
- Derived from this study: PubMed 19349389Terra RM, Junqueira JJM, Teixeira LR, Vargas FS, Pego-Fernandes PM, Jatene FB. Is full postpleurodesis lung expansion a determinant of a successful outcome after talc pleurodesis? Chest. 2009 Aug;136(2):361-368. doi: 10.1378/chest.08-2448. Epub 2009 Apr 6.
Related trials for Recurrent Malignant Pleural Effusion.
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Comparison of Talc Slurry Versus Talc Insufflation: A Study on Effectiveness, Safety, and Hospital Outcomes in Pleurodesis
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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.
Ricardo M. Terra, MD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Videothoracoscopic talc poudrage (VT). and Talc slurry through a chest tube (DT). in people with Recurrent Malignant Pleural Effusion., run by University of Sao Paulo at 1 site in Brazil.
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 5 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 11 Nov 2008. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Radiological lung expansion after talc pleurodesis and clinical outcome (time frame: 6 months). 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 NCT00789087, which also lists 1 linked publication.
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 11 Nov 2008.