Pleural Effusion, MalignantPhase 4ASAPNCT00978939
Impact of Aggressive Versus Standard Drainage Regimen Using a Long Term Indwelling Pleural Catheter
A Phase 4 study testing Standard Drainage Instructions and Aggressive Drainage Instructions in people with Pleural Effusion, Malignant, run by Duke University at 6 sites in United States.
Trial summary
Purpose and Objective: The purpose of this study is to determine if the rate of spontaneous pleurodesis using the Pleurx® catheter could be increased by simply increasing the frequency of pleural drainage and, if so, whether catheter-related complications can be minimized and spare patients the need for long term… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pleural Effusion, Malignant
- What is being tested?
- Standard Drainage Instructions and Aggressive Drainage Instructions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2009to Oct 2013
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years old
- Pleural effusion (etiology fulfilling one of the following criteria):
- Malignant effusion confirmed by cytology or pleural biopsy
- Exudative effusion in the setting of known malignancy with no other identifiable cause
- Malignant effusion due to tumors that are historically rapidly responsive to systemic therapy (small cell lung cancer, hematological malignancies) will only be included if refractory to standard chemotherapy
- Symptoms such as shortness of breath, cough, or chest fullness/chest discomfort
Show all 10Show fewer
- Age greater than 18 years old
- Pleural effusion (etiology fulfilling one of the following criteria):
- Demonstration of symptomatic improvement after therapeutic thoracentesis (removal of ≤ 1.5 L of pleural fluid)
- Recurrent pleural effusion after therapeutic thoracentesis
Who cannot join
- Projected life expectancy less than 30 days as predicted by Karnofsky Performance Status score less than 30
- Radiographic evidence of trapped lung - persistent lung collapse with failure of the lung to reexpand following drainage of a pleural effusion
- Radiographic evidence of loculated pleural fluid
- Previous attempted pleurodesis on the affected side
- Previous lobectomy or pneumonectomy on the affected side
- Patient receiving intrapleural chemotherapy
Show all 13Show fewer
- Chylothorax - pleural effusion with triglyceride levels > 110 mg/dl or chylomicrons on lipoprotein analysis, most commonly due to trauma/obstruction of the thoracic duct
- Parapneumonic effusion - pleural effusion associated with pneumonia
- Empyema - infected pleural space as defined by purulent pleural fluid, positive gram stain, or positive culture
- Inability to adequately perform pleural drainage at home
- Uncorrectable bleeding disorder
- Skin infection at the site of intended catheter insertion
- Pregnancy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Lahey Clinic
Burlington, Massachusetts, 01805
National Jewish Medical Center
Denver, Colorado, 80206
Duke University Medical Center
Durham, North Carolina, 27710
University of Utah
Salt Lake City, Utah, 84132-4701
About this study
Official title: Impact of Aggressive Versus Standard Drainage Regimen Using a Long Term Indwelling Pleural Catheter on the Incidence of Auto-Pleurodesis in Patients With Malignant Pleural Effusions
Purpose and Objective: The purpose of this study is to determine if the rate of spontaneous pleurodesis using the Pleurx® catheter could be increased by simply increasing the frequency of pleural drainage and, if so, whether catheter-related complications can be minimized and spare patients the need for long term management of the Pleurx® catheter.
Read the detailed description
Study Population: Patients greater than 18 years of age with malignant pleural effusions will be identified and approached in clinic by the Principle and Co-Investigator. Informed consent will be obtained from qualified and interested patients.
Study Activities: Patients will be randomized to standard and aggressive drainage groups and complete questionnaires regarding their health. Patients will then receive the Pleurx® catheter for standard treatment of their malignant pleural effusions, obtain a chest-xray, and receive educational instruction and training on catheter drainage and told whether to drain everyday using a 1-liter bottle or every other day using a 600-cc bottle. Patients will complete a drainage diary on everyday they drain fluid which will provide information on drainage volume, fluid color, pain, and complications. At 2 weeks, 6 weeks, and 12 weeks post catheter placement, patients will return to clinic for follow-up at which time they will have an interval history and physical and chest xray and complete a questionnaires regarding their health and satisfaction.
Risks/Safety Issues: Risks associated with draining the catheter include: pneumothorax, re-expansion pulmonary edema, hypotension, circulatory collapse, and infection. All serious adverse events will be reported to the institutional review board: a) death - immediately; b) life-threatening within 7 calendar days; c) all other SAEs (serious adverse events) within 15 calendar days. Should there be a serious adverse event that occurs that increases the risk to the participants, the study will be stopped, an investigation will be conducted, and a findings report will be generated before the study is resumed.
Data Analysis: The principal endpoint is the incidence of successful pleurodesis utilizing an aggressive drainage protocol compared to the incidence of successful pleurodesis using a standard drainage protocol. An interim analysis will be performed after 3 months.
- Conditions
- Pleural Effusion, Malignant
- Being tested
- Standard Drainage Instructions, Aggressive Drainage Instructions
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Drainage InstructionsOther
Also called Conventional Drainage
Patients will receive specific instructions to drain up to 1 liter of pleural fluid every other day
Aggressive Drainage InstructionsOther
Also called Daily Drainage
Patients will receive specific instructions to drain up to 1 liter of pleural fluid daily
| Study group | Role | What they receive |
|---|---|---|
| Aggressive Drainage Arm | Experimental | Patients will drain up to 1 liter of pleural fluid everyday Receives: Other: Aggressive Drainage Instructions |
| Standard Drainage Arm | Active comparator | Patients will drain up to 1 liter of pleural fluid every other day Receives: Other: Standard Drainage Instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the incidence of auto-pleurodesis utilizing aggressive drainage versus standard drainage protocols with the PleuRx® catheter
Measured: 2, 6, and 12 weeks post-catheter insertion
Secondary outcomes (4)
To determine the median time to auto-pleurodesis utilizing aggressive drainage versus standard drainage protocols with the PleuRx® catheter
Measured: 2, 6, and 12 weeks post-catheter insertion
To assess the effects of aggressive drainage versus standard drainage protocols with the PleuRx® catheter on functional health status
Measured: 2, 6, and 12 weeks post-catheter insertion
To determine predictors of auto-pleurodesis (volume and rate of pleural fluid drainage, biochemical, and radiographic) using post-hoc analysis in both the aggressive and standard drainage protocols
Measured: 2, 6, and 12 weeks post-catheter insertion
To determine patient and caregivers' satisfaction with the PleuRx® catheter using a questionnaire
Measured: 2, 6, and 12 weeks post-catheter insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pleural Effusion, MalignantStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- C. R. Bard
- Responsible party
- Sponsor
- Investigators
- Momen Wahidi, MD, MBA, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978939
- Sponsor's protocol ID
- Pro00016092
- Acronym
- ASAP
- Status last verified
- Dec 2013
- First submitted
- 15 Sep 2009
- Last updated
- 30 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tremblay A, Michaud G. Single-center experience with 250 tunnelled pleural catheter insertions for malignant pleural effusion. Chest. 2006 Feb;129(2):362-368. doi: 10.1378/chest.129.2.362.
PubMed 16478853Musani AI, Haas AR, Seijo L, Wilby M, Sterman DH. Outpatient management of malignant pleural effusions with small-bore, tunneled pleural catheters. Respiration. 2004 Nov-Dec;71(6):559-66. doi: 10.1159/000081755.
PubMed 15627865Barkauskas CE, Wahidi MM. Rate of auto pleurodesis with the indwelling pleural catheter using an aggressive drainage protocol in patients with malignant pleural effusions. Submitted for American Thoracic Society 2006 Meeting.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aggressive Versus Standard Drainage Regimen Using a Long Term Indwelling Pleural Catheter on the Incidence of Auto-Pleurodesis in Patients With Malignant Pleural Effusions
- ClinicalTrials.gov ID
- NCT00978939
- Acronym / sponsor ID
- ASAP / Pro00016092
- Conditions
- Pleural Effusion, Malignant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- C. R. Bard
- Study start
- Aug 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 17 Sep 2009 (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.
Purpose and Objective: The purpose of this study is to determine if the rate of spontaneous pleurodesis using the Pleurx® catheter could be increased by simply increasing the frequency of pleural drainage and, if so, whether catheter-related complications can be minimized and spare patients the need for long term management of the Pleurx® catheter.
Detailed description
Study Population: Patients greater than 18 years of age with malignant pleural effusions will be identified and approached in clinic by the Principle and Co-Investigator. Informed consent will be obtained from qualified and interested patients.
Study Activities: Patients will be randomized to standard and aggressive drainage groups and complete questionnaires regarding their health. Patients will then receive the Pleurx® catheter for standard treatment of their malignant pleural effusions, obtain a chest-xray, and receive educational instruction and training on catheter drainage and told whether to drain everyday using a 1-liter bottle or every other day using a 600-cc bottle. Patients will complete a drainage diary on everyday they drain fluid which will provide information on drainage volume, fluid color, pain, and complications. At 2 weeks, 6 weeks, and 12 weeks post catheter placement, patients will return to clinic for follow-up at which time they will have an interval history and physical and chest xray and complete a questionnaires regarding their health and satisfaction.
Risks/Safety Issues: Risks associated with draining the catheter include: pneumothorax, re-expansion pulmonary edema, hypotension, circulatory collapse, and infection. All serious adverse events will be reported to the institutional review board: a) death - immediately; b) life-threatening within 7 calendar days; c) all other SAEs (serious adverse events) within 15 calendar days. Should there be a serious adverse event that occurs that increases the risk to the participants, the study will be stopped, an investigation will be conducted, and a findings report will be generated before the study is resumed.
Data Analysis: The principal endpoint is the incidence of successful pleurodesis utilizing an aggressive drainage protocol compared to the incidence of successful pleurodesis using a standard drainage protocol. An interim analysis will be performed after 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aggressive Drainage Arm | Experimental | Other: Aggressive Drainage InstructionsPatients will drain up to 1 liter of pleural fluid everyday |
| Standard Drainage Arm | Active comparator | Other: Standard Drainage InstructionsPatients will drain up to 1 liter of pleural fluid every other day |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age greater than 18 years old
- Pleural effusion (etiology fulfilling one of the following criteria):
- Symptoms such as shortness of breath, cough, or chest fullness/chest discomfort
- Age greater than 18 years old
- Pleural effusion (etiology fulfilling one of the following criteria):
Key exclusion criteria (13 listed)
- Projected life expectancy less than 30 days as predicted by Karnofsky Performance Status score less than 30
- Radiographic evidence of trapped lung - persistent lung collapse with failure of the lung to reexpand following drainage of a pleural effusion
- Radiographic evidence of loculated pleural fluid
- Previous attempted pleurodesis on the affected side
- Previous lobectomy or pneumonectomy on the affected side
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 |
|---|---|---|
| Standard Drainage InstructionsAlso: Conventional DrainagePatients will receive specific instructions to drain up to 1 liter of pleural fluid every other day | Other | Standard Drainage Arm |
| Aggressive Drainage InstructionsAlso: Daily DrainagePatients will receive specific instructions to drain up to 1 liter of pleural fluid daily | Other | Aggressive Drainage Arm |
Primary outcome
To compare the incidence of auto-pleurodesis utilizing aggressive drainage versus standard drainage protocols with the PleuRx® catheter
Time frame: 2, 6, and 12 weeks post-catheter insertion
4 secondary outcomes
To determine the median time to auto-pleurodesis utilizing aggressive drainage versus standard drainage protocols with the PleuRx® catheter
Time frame: 2, 6, and 12 weeks post-catheter insertion
To assess the effects of aggressive drainage versus standard drainage protocols with the PleuRx® catheter on functional health status
Time frame: 2, 6, and 12 weeks post-catheter insertion
To determine predictors of auto-pleurodesis (volume and rate of pleural fluid drainage, biochemical, and radiographic) using post-hoc analysis in both the aggressive and standard drainage protocols
Time frame: 2, 6, and 12 weeks post-catheter insertion
To determine patient and caregivers' satisfaction with the PleuRx® catheter using a questionnaire
Time frame: 2, 6, and 12 weeks post-catheter insertion
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 30 Dec 2013.
- Background: PubMed 16478853Tremblay A, Michaud G. Single-center experience with 250 tunnelled pleural catheter insertions for malignant pleural effusion. Chest. 2006 Feb;129(2):362-368. doi: 10.1378/chest.129.2.362.
- Background: PubMed 15627865Musani AI, Haas AR, Seijo L, Wilby M, Sterman DH. Outpatient management of malignant pleural effusions with small-bore, tunneled pleural catheters. Respiration. 2004 Nov-Dec;71(6):559-66. doi: 10.1159/000081755.
- BackgroundBarkauskas CE, Wahidi MM. Rate of auto pleurodesis with the indwelling pleural catheter using an aggressive drainage protocol in patients with malignant pleural effusions. Submitted for American Thoracic Society 2006 Meeting.
Related trials for Pleural Effusion, Malignant
Not yet recruitingObservational study
Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
RecruitingObservational study
UNC Pleural Fluid Registry
Lung Cancer, Lung Infection
Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Advanced Cancer, Pleural Effusion
RecruitingObservational study
Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions
Pleural Neoplasm
Recruiting
Safety and Feasibility of Medical Thoracoscopy Using Single-use Flexible Bronchoscope Versus SemiRigid Pleuroscope in Pleural Effusion
Malignant Pleural Effusions (Mpe), Medical Thoracoscopy
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.
Momen Wahidi, MD, MBA principal investigator
Duke University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard Drainage Instructions and Aggressive Drainage Instructions in people with Pleural Effusion, Malignant, run by Duke University at 6 sites in United States.
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 10 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: finished, as of the sponsor's last update on 30 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
To compare the incidence of auto-pleurodesis utilizing aggressive drainage versus standard drainage protocols with the PleuRx® catheter (time frame: 2, 6, and 12 weeks post-catheter insertion). 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 NCT00978939, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2013.