Pleural Effusion, MalignantEarly Phase 1NCT02825095
Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis
A Early Phase 1 study testing Talc Pleurodesis, Indwelling Pleural Catheter and chest ultrasound in people with Pleural Effusion, Malignant and Lung Neoplasms, run by Rambam Health Care Campus.
Trial summary
Prospective study of the effect of Talc Pleurodesis vs. Indwelling Pleural catheter in treatment of patients with malignant pleural effusion Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pleural Effusion, Malignant, Lung Neoplasms
- What is being tested?
- Talc Pleurodesis, Indwelling Pleural Catheter and chest ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Aug 2017
- Phase
- Early Phase 1
- 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
- Patients with recurrent symptomatic pleural effusion, the diagnosis was obtained by : - positive cytology for malignant cells in the fluid.
- patients well known for malignancy, with exudative pleural effusion with no alternative diagnosis.
- pleural biopsy - surgically obtained - with diagnosis of pleural malignancy
- microscopic intraoperative findings suggestive of pleural malignancy.
- Patients who underwent prior to involvement in the study, draining of the pleural fluid with symptomatic improvement.
- Patients with rate of fluid accumulation less than 30 days.
- Patient who signed informed consent about being involved in the study.
Who cannot join
- Patients under the age of 18 years.
- Female patients who are Pregnant or nursing.
- Patients with rate of pleural effusion accumulation is more than 30 days.
- Patients who didn't show clinical improvement post proper draining of the fluid
- Patients who are hemodynamically or respiratory unstable.
- Patients with Empyema.
Show all 11Show fewer
- Patients who are non functioning/ not active according to the Performance status.
- The type of malignancy which cause the malignant pleural effusion is Lymphoma.
- Patient who underwent pneumonectomy at the side of the fluid.
- previous pleurodesis at the side of pleural effusion.
- Chylothorax in the initial pleural tapping.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis ; a Prospective Randomized Controlled Study.
Prospective study of the effect of Talc Pleurodesis vs. Indwelling Pleural catheter in treatment of patients with malignant pleural effusion
Read the detailed description
Randomized prospective study that will include 120 patients with malignant pleural effusion with high rate of accumulation; less than one month, The patients will be divided randomly for two groups, each group 60 patients, the first group will undergoes talc pleurodesis, the second group will undergoes Indwelling Pleural catheter insertion.
The two groups will be followed up for one year, starting at the time of intervention, after 14 days of intervention, after 30 days of intervention, once monthly for one year.
The patients will be evaluated according to the rate of complication; need for further intervention in each group, improvement of the quality of life, respiratory improvement, radiological evaluation based on chest Xray findings, rate and duration of admissions that are related to pleural effusion during the year of study.
- Conditions
- Pleural Effusion, Malignant, Lung Neoplasms
- Being tested
- Talc Pleurodesis, Indwelling Pleural Catheter, chest ultrasound, Local anesthesia, Chest Tube
- Keywords
- malignant pleural effusion,talc pleurodesis,quality of life
- Medical subject headings
- Pleural Effusion, Malignant, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talc PleurodesisProcedure or surgery
chest tube type PIGTAIL 10 - 14 Fr will be inserted to the pleural space. In case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed
Indwelling Pleural CatheterProcedure or surgery
Indwelling Pleural Catheter type PLEURAX will be inserted to the pleural space. the patients will be discharged with the pleural catheter.
chest ultrasoundProcedure or surgery
All insertion of a chest drain will be guided by ultrasound
Local anesthesiaDrug
Also called Lidocaine hydrochloride, Esracain injection 2%
Inserting a chest drain will be after local anesthesia with 10-20 mL of Lidocaine hydrochloride 20MG/ML - Esracain injection 2%
Chest TubeProcedure or surgery
Also called PIGTAIL
chest tube type PIGTAIL 10 - 14 Fr will be inserted to the pleural space. In case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed
| Study group | Role | What they receive |
|---|---|---|
| Talc Pleurodesis | Active comparator | For patients in this group, chest tube type PIGTAIL 10 - 14 Fr will be inserted by by chest ultrasound guided and under local anesthesia, allowing good draining of the hemithorax, in case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed, chest tube will be removed 24 - 48 hours later on. the patient will be admitted in the hospital during the whole procedure course.
If the patient developed non expanded - trapped lung post chest tube insertion, or if he had persistence high chest tube output for more than 10 days, then the patient will remain with the PIGTAIL as an Indwelling Pleural Catheter. Receives: Procedure: Talc Pleurodesis; Procedure: chest ultrasound; Drug: Local anesthesia; Procedure: Chest Tube |
| Indwelling Pleural Catheter | Active comparator | All patients from this group will have Indwelling Pleural Catheter insertion type PLEURAX inserted by ultrasound guided and under local anesthesia.
the patient and his/her family will be instructed and educated about the proper way of using the catheter, and how to perform pleural draining at home.
the duration of treatment with the Pleurax depends on the rate and amount of pleural effusion draining. Receives: Procedure: Indwelling Pleural Catheter; Procedure: chest ultrasound; Drug: Local anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Quality of Life
the patients will be followed up 14 days post intervention, 30 days, once monthly for 12 months, the patient will fill questioner every month evaluating the quality of life, the daily activities and the degree of shortness of breath.
Measured: one year of regular follow up.
Secondary outcomes (1)
procedure and admissions
The patients will be evaluated for the number of admissions: e.g: how many times he/she was admitted to the hospital, duration of admissions; how many days he was admitted in the hospital each time and procedure related to pleural effusion; types and number of procedures
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionMay 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pleural Effusion, MalignantStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825095
- Sponsor's protocol ID
- 0371-15rmb
- Status last verified
- Jul 2016
- First submitted
- 4 Apr 2016
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Heffner JE, Klein JS. Recent advances in the diagnosis and management of malignant pleural effusions. Mayo Clin Proc. 2008 Feb;83(2):235-50. doi: 10.4065/83.2.235.
PubMed 18241636Roberts ME, Neville E, Berrisford RG, Antunes G, Ali NJ; BTS Pleural Disease Guideline Group. Management of a malignant pleural effusion: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii32-40. doi: 10.1136/thx.2010.136994. No abstract available.
PubMed 20696691Sahn SA. Pleural diseases related to metastatic malignancies. Eur Respir J. 1997 Aug;10(8):1907-13. doi: 10.1183/09031936.97.10081907.
PubMed 9272937Uzbeck MH, Almeida FA, Sarkiss MG, Morice RC, Jimenez CA, Eapen GA, Kennedy MP. Management of malignant pleural effusions. Adv Ther. 2010 Jun;27(6):334-47. doi: 10.1007/S12325-010-0031-8. Epub 2010 Jun 10.
PubMed 20544327Chernow B, Sahn SA. Carcinomatous involvement of the pleura: an analysis of 96 patients. Am J Med. 1977 Nov;63(5):695-702. doi: 10.1016/0002-9343(77)90154-1. No abstract available.
PubMed 930945American Thoracic Society. Management of malignant pleural effusions. Am J Respir Crit Care Med. 2000 Nov;162(5):1987-2001. doi: 10.1164/ajrccm.162.5.ats8-00. No abstract available.
PubMed 11069845Nam HS. Malignant pleural effusion: medical approaches for diagnosis and management. Tuberc Respir Dis (Seoul). 2014 May;76(5):211-7. doi: 10.4046/trd.2014.76.5.211. Epub 2014 May 29.
PubMed 24920947Zarogoulidis K, Zarogoulidis P, Darwiche K, Tsakiridis K, Machairiotis N, Kougioumtzi I, Courcoutsakis N, Terzi E, Zaric B, Huang H, Freitag L, Spyratos D. Malignant pleural effusion and algorithm management. J Thorac Dis. 2013 Sep;5 Suppl 4(Suppl 4):S413-9. doi: 10.3978/j.issn.2072-1439.2013.09.04.
PubMed 24102015Olden AM, Holloway R. Treatment of malignant pleural effusion: PleuRx catheter or talc pleurodesis? A cost-effectiveness analysis. J Palliat Med. 2010 Jan;13(1):59-65. doi: 10.1089/jpm.2009.0220.
PubMed 19839739Chee A, Tremblay A. The use of tunneled pleural catheters in the treatment of pleural effusions. Curr Opin Pulm Med. 2011 Jul;17(4):237-41. doi: 10.1097/MCP.0b013e3283463dac.
PubMed 21460729Srour N, Amjadi K, Forster A, Aaron S. Management of malignant pleural effusions with indwelling pleural catheters or talc pleurodesis. Can Respir J. 2013 Mar-Apr;20(2):106-10. doi: 10.1155/2013/842768.
PubMed 23616967
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis ; a Prospective Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT02825095
- Acronym / sponsor ID
- 0371-15rmb
- Conditions
- Pleural Effusion, Malignant, Lung Neoplasms
- Keywords
- malignant pleural effusion,talc pleurodesis,quality of life
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 7 Jul 2016 (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.
Prospective study of the effect of Talc Pleurodesis vs. Indwelling Pleural catheter in treatment of patients with malignant pleural effusion
Detailed description
Randomized prospective study that will include 120 patients with malignant pleural effusion with high rate of accumulation; less than one month, The patients will be divided randomly for two groups, each group 60 patients, the first group will undergoes talc pleurodesis, the second group will undergoes Indwelling Pleural catheter insertion.
The two groups will be followed up for one year, starting at the time of intervention, after 14 days of intervention, after 30 days of intervention, once monthly for one year.
The patients will be evaluated according to the rate of complication; need for further intervention in each group, improvement of the quality of life, respiratory improvement, radiological evaluation based on chest Xray findings, rate and duration of admissions that are related to pleural effusion during the year of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Talc Pleurodesis | Active comparator | Procedure: Talc Pleurodesis, Procedure: chest ultrasound, Drug: Local anesthesia, Procedure: Chest TubeFor patients in this group, chest tube type PIGTAIL 10 - 14 Fr will be inserted by by chest ultrasound guided and under local anesthesia, allowing good draining of the hemithorax, in case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed, chest tube will be removed 24 - 48 hours later on. the patient will be admitted in the hospital during the whole procedure course. If the patient developed non expanded - trapped lung post chest tube insertion, or if he had persistence high chest tube output for more than 10 days, then the patient will remain with the PIGTAIL as an Indwelling Pleural Catheter. |
| Indwelling Pleural Catheter | Active comparator | Procedure: Indwelling Pleural Catheter, Procedure: chest ultrasound, Drug: Local anesthesiaAll patients from this group will have Indwelling Pleural Catheter insertion type PLEURAX inserted by ultrasound guided and under local anesthesia. the patient and his/her family will be instructed and educated about the proper way of using the catheter, and how to perform pleural draining at home. the duration of treatment with the Pleurax depends on the rate and amount of pleural effusion draining. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with recurrent symptomatic pleural effusion, the diagnosis was obtained by : - positive cytology for malignant cells in the fluid.
- Patients who underwent prior to involvement in the study, draining of the pleural fluid with symptomatic improvement.
- Patients with rate of fluid accumulation less than 30 days.
- Patient who signed informed consent about being involved in the study.
Key exclusion criteria (11 listed)
- Patients under the age of 18 years.
- Female patients who are Pregnant or nursing.
- Patients with rate of pleural effusion accumulation is more than 30 days.
- Patients who didn't show clinical improvement post proper draining of the fluid
- Patients who are hemodynamically or respiratory unstable.
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 Pleurodesischest tube type PIGTAIL 10 - 14 Fr will be inserted to the pleural space. In case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed | Procedure or surgery | Talc Pleurodesis |
| Indwelling Pleural CatheterIndwelling Pleural Catheter type PLEURAX will be inserted to the pleural space. the patients will be discharged with the pleural catheter. | Procedure or surgery | Indwelling Pleural Catheter |
| chest ultrasoundAll insertion of a chest drain will be guided by ultrasound | Procedure or surgery | Indwelling Pleural Catheter, Talc Pleurodesis |
| Local anesthesiaAlso: Lidocaine hydrochloride, Esracain injection 2%Inserting a chest drain will be after local anesthesia with 10-20 mL of Lidocaine hydrochloride 20MG/ML - Esracain injection 2% | Drug | Indwelling Pleural Catheter, Talc Pleurodesis |
| Chest TubeAlso: PIGTAILchest tube type PIGTAIL 10 - 14 Fr will be inserted to the pleural space. In case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed | Procedure or surgery | Talc Pleurodesis |
Primary outcome
change in Quality of Life
Time frame: one year of regular follow up.
the patients will be followed up 14 days post intervention, 30 days, once monthly for 12 months, the patient will fill questioner every month evaluating the quality of life, the daily activities and the degree of shortness of breath.
1 secondary outcome
procedure and admissions
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Background: PubMed 18241636Heffner JE, Klein JS. Recent advances in the diagnosis and management of malignant pleural effusions. Mayo Clin Proc. 2008 Feb;83(2):235-50. doi: 10.4065/83.2.235.
- Background: PubMed 20696691Roberts ME, Neville E, Berrisford RG, Antunes G, Ali NJ; BTS Pleural Disease Guideline Group. Management of a malignant pleural effusion: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii32-40. doi: 10.1136/thx.2010.136994. No abstract available.
- Background: PubMed 9272937Sahn SA. Pleural diseases related to metastatic malignancies. Eur Respir J. 1997 Aug;10(8):1907-13. doi: 10.1183/09031936.97.10081907.
- Background: PubMed 20544327Uzbeck MH, Almeida FA, Sarkiss MG, Morice RC, Jimenez CA, Eapen GA, Kennedy MP. Management of malignant pleural effusions. Adv Ther. 2010 Jun;27(6):334-47. doi: 10.1007/S12325-010-0031-8. Epub 2010 Jun 10.
- Background: PubMed 930945Chernow B, Sahn SA. Carcinomatous involvement of the pleura: an analysis of 96 patients. Am J Med. 1977 Nov;63(5):695-702. doi: 10.1016/0002-9343(77)90154-1. No abstract available.
- Background: PubMed 11069845American Thoracic Society. Management of malignant pleural effusions. Am J Respir Crit Care Med. 2000 Nov;162(5):1987-2001. doi: 10.1164/ajrccm.162.5.ats8-00. No abstract available.
- Background: PubMed 24920947Nam HS. Malignant pleural effusion: medical approaches for diagnosis and management. Tuberc Respir Dis (Seoul). 2014 May;76(5):211-7. doi: 10.4046/trd.2014.76.5.211. Epub 2014 May 29.
- Background: PubMed 24102015Zarogoulidis K, Zarogoulidis P, Darwiche K, Tsakiridis K, Machairiotis N, Kougioumtzi I, Courcoutsakis N, Terzi E, Zaric B, Huang H, Freitag L, Spyratos D. Malignant pleural effusion and algorithm management. J Thorac Dis. 2013 Sep;5 Suppl 4(Suppl 4):S413-9. doi: 10.3978/j.issn.2072-1439.2013.09.04.
- Background: PubMed 19839739Olden AM, Holloway R. Treatment of malignant pleural effusion: PleuRx catheter or talc pleurodesis? A cost-effectiveness analysis. J Palliat Med. 2010 Jan;13(1):59-65. doi: 10.1089/jpm.2009.0220.
- Background: PubMed 21460729Chee A, Tremblay A. The use of tunneled pleural catheters in the treatment of pleural effusions. Curr Opin Pulm Med. 2011 Jul;17(4):237-41. doi: 10.1097/MCP.0b013e3283463dac.
- Background: PubMed 23616967Srour N, Amjadi K, Forster A, Aaron S. Management of malignant pleural effusions with indwelling pleural catheters or talc pleurodesis. Can Respir J. 2013 Mar-Apr;20(2):106-10. doi: 10.1155/2013/842768.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Talc Pleurodesis, Indwelling Pleural Catheter and chest ultrasound in people with Pleural Effusion, Malignant and Lung Neoplasms, run by Rambam Health Care Campus.
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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 7 Jul 2016. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ran Kremer, MD (00972502063189, r_kremer@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Quality of Life (time frame: one year of regular follow up.). 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 NCT02825095, which also lists 11 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 7 Jul 2016.