Pleural Effusion, MalignantRAPIDNCT03325192
Rapid Pleurodesis Through an Indwelling Pleural Catheter
A study testing Rapid pleurodesis protocol in people with Pleural Effusion, Malignant and Pleurodesis, run by University of Pennsylvania at 1 site in United States.
Trial summary
The primary objective of the study is to evaluate whether the use of a rapid pleurodesis protocol using 10% iodopovidone immediately after tunneled pleural catheter placement improves time to IPC removal compared to patients who receive an IPC alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Malignant, Pleurodesis, Pleural Diseases
- What is being tested?
- Rapid pleurodesis protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2017to 9 Jul 2019
- 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
- Diagnosis of MPE as defined by
- A diagnosis a pleural effusion in the setting of known malignancy. AND
- Confirmed malignant involvement of the pleural space by fluid cytology or pleural biopsy. OR
- Evidence of pleural disease on radiographic imaging. OR
- A recurrent effusion with no other identifiable cause after thorough workup.
- Symptomatic from the pleural effusions (shortness of breath, cough, or chest pain)
Show all 9Show fewer
- Prior thoracentesis with post procedure symptomatic relief
- Recurrence of symptoms with re-accumulation of pleural effusion
- Lung re-expansion after thoracentesis on chest imaging within last 30 days
Who cannot join
- Malignant pleural effusion due to a hematologic malignancy
- ECOG >4
- Any history of trapped lung
- Prior attempted pleurodesis on the affected site
- Age <18
- Pregnant or lactating
Show all 12Show fewer
- Known allergy to iodopovidone (Betadine)
- Unable or unwilling to provide consent
- Uncorrectable coagulopathy (INR > 1.5, aPTT > 1.5 x the upper limit of normal) or thrombocytopenia (< 50,000)
- Anatomic contraindication to IPC (overlying skin abnormalities)
- Unable or unwilling to care for IPC and adhere to drainage protocol
- Need for bilateral IPC placement
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized, Double Blinded, Controlled Trial of a Rapid Pleurodesis Protocol After Indwelling Pleural Catheter Placement for Malignant Pleural Effusions
The primary objective of the study is to evaluate whether the use of a rapid pleurodesis protocol using 10% iodopovidone immediately after tunneled pleural catheter placement improves time to IPC removal compared to patients who receive an IPC alone.
Read the detailed description
Patients will be screened throughout the year as part of the clinical referral process to the Interventional Pulmonology service at the Hospital of the University of Pennsylvania for the management of a malignant pleural effusion. Patients eligible for inclusion based on the clinical evaluation will be approached for enrollment. Written consent will be obtained. Patients will subsequently undergo placement of a IPC under MAC as per standard clinical practice followed by complete drainage of the pleural space. Patients randomized to the rapid pleurodesis protocol arm will received 20mL of 10% iodopovidone mixed with 80mL of normal saline instilled intrapleurally through the IPC. Patients randomized to the standard of care arm will have 100mL of normal saline (placebo) instilled intrapleurally through the IPC. The mixture will be allowed to dwell for 2 hours and then completely evacuated through the IPC and the patient will be discharged home.
After discharge, all patients will continue to drain their IPC on a daily basis for 7 days. Following this, all patients will continue to drain their IPC on an every-other-day basis until total IPC output is less than 50ml per session over 3 consecutive sessions. At which point they will be asked to undergo a clamp trial of no drainage for 7 days followed by a reattempt at drainage. Patients without return of symptoms over those 7 days and minimal drainage afterwards (<50ml) will be seen in the office for possible IPC removal. Patients with return of symptoms during those 7 days or more than minimal drainage afterwards (>50mL) will be asked to continue drainage until total IPC output is again less than 50mL per session over 3 sessions.
After a passed clamp trial, patients will be evaluated in the office with a bedside ultrasound to assess for pleural apposition in 5 of 6 designated points and the absence of pleural effusions. If all criteria are met, the IPC is removed. If there is evidence of residual effusion, continued drainage will be advised.
All patients will be evaluated in the office on day 7, day 14, day 30, day 60 and day 90 after IPC placement. On each visit they will be assessed for pleural apposition with ultrasound. At day 30, 60, and 90 all patients will receive a global health related questionnaire (EORTC QLQ30) and a symptom questionnaire. At 90 days, complications rate will be assessed for the entire study period.
- Conditions
- Pleural Effusion, Malignant, Pleurodesis, Pleural Diseases
- Being tested
- Rapid pleurodesis protocol, Placebo
- Keywords
- Indwelling Pleural Catheter, Pleurodesis, Iodopovidone, Pleural Effusion, Malignant
- Medical subject headings
- Pleural Effusion, Malignant, Pleural Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid pleurodesis protocolDrug
Also called iodine pleurodesis
- The pleural space will be evacuated completely through the newly placed IPC
- 20mL of 10% iodopovidone and 80mL of normal saline will be instilled into the pleural space
- The patient will be transferred to the recovery unit
- Two hours after instillation the pleural space will be drained
- After recovery from anesthesia and complete drainage of the pleurodesis mix, the subject will be discharged
- Subjects will be asked to drain their effusion on a daily basis for the next 7 days and then on an every other day basis.
PlaceboOther
- The pleural space will be evacuated completely through the newly placed IPC
- Only placebo (normal saline) will be instilled into the pleural space
- The patient will be transferred to the recovery unit
- Two hours after instillation the pleural space will be drained
- After recovery from anesthesia and complete drainage of the pleurodesis mix, the subject will be discharged
- Subjects will be asked to drain their effusion on a daily basis for the next 7 days and then on an every other day basis.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Placebo comparator | Subjects in this arm will receive placebo only (100mL of normal saline) into the pleural space delivered via the newly placed tunneled intrapleural catheter Receives: Other: Placebo |
| Rapid pleurodesis protocol | Experimental | Subjects in this arm will receive the chemical pleurodesing agent of 10% iodopovidone solution delivered to the pleural space via the newly placed tunneled intrapleural catheter Receives: Drug: Rapid pleurodesis protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to catheter removal
Time to IPC removal will be measured in days from the day of IPC placement to the day of IPC removal after meeting removal criteria as listed above.
Measured: 90 days
Secondary outcomes (4)
Change in Global Health Related Quality of Life
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQC30) will be used to assess global health-related quality of life. This is a 30-item questionnaire validated for use in patients with cancer. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: 30 days, 60 days, and 90 days after catheter placement
Change in symptoms of pain and breathlessness
We will use a 5 point Likert scale (5PLS) that has been created for the trial. Patients will be asked to indicate their degree of shortness of breath or chest pain during sitting, walking and lying down/sleeping on that specific day. Thus, a total of 6 scales will be utilized. Point 1 will be described as "no shortness of breath" or "no chest pain." Point 2 will be described as "mild shortness of breath" or "mild chest pain." Point 3 will be described as "moderate shortness of breath" or "moderate chest pain." Point 4 will be described as "severe shortness of breath" or "severe chest pain." Point 5 will be described as "Worst shortness of breath possible" or "Worst chest pain possible."
Measured: 30 days, 60 days, and 90 days after catheter placement
Time to return of clinically significant pleural effusion
This will be measured in days from the day of IPC removal to the day of return of a clinically significant pleural effusion in the same hemithorax that originally required IPC placement. A clinically significant reaccumulation of pleural fluid will be defined as an effusion with a maximum fluid depth greater than 25% of the AP window on chest CT or 1cm thoracic ultrasound along the lateral 1/3 of the thorax that is associated with shortness of breath or chest pain
Measured: 90 days
Rate of successful pleurodesis at 90 days
Successful pleurodesis will be defined as removal of the IPC with no clinically significant reaccumulation of pleural fluid as evaluated by chest CT or thoracic ultrasound. A clinically significant reaccumulation of pleural fluid will be defined as an effusion with a maximum fluid depth greater than 25% of the AP window on chest CT or 1cm thoracic ultrasound along the lateral 1/3 of the thorax that is associated with shortness of breath or chest pain.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start12 Dec 2017
- Primary completion9 Jul 2019
- Study completion9 Jul 2019
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)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 University of PennsylvaniaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Randomized, Controlled, Double Blinded, Parallel Design, Trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Ma, MD, University of Pennsylvania
- Investigators
- Kevin C Ma, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325192
- Sponsor's protocol ID
- 827688
- Acronym
- RAPID
- Status last verified
- May 2020
- First submitted
- 24 Oct 2017
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Antunes G, Neville E, Duffy J, Ali N; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the management of malignant pleural effusions. Thorax. 2003 May;58 Suppl 2(Suppl 2):ii29-38. doi: 10.1136/thorax.58.suppl_2.ii29. No abstract available.
PubMed 12728148American 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 11069845Davies HE, Mishra EK, Kahan BC, Wrightson JM, Stanton AE, Guhan A, Davies CW, Grayez J, Harrison R, Prasad A, Crosthwaite N, Lee YC, Davies RJ, Miller RF, Rahman NM. Effect of an indwelling pleural catheter vs chest tube and talc pleurodesis for relieving dyspnea in patients with malignant pleural effusion: the TIME2 randomized controlled trial. JAMA. 2012 Jun 13;307(22):2383-9. doi: 10.1001/jama.2012.5535.
PubMed 22610520Roberts 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 20696691Wahidi MM, Reddy C, Yarmus L, Feller-Kopman D, Musani A, Shepherd RW, Lee H, Bechara R, Lamb C, Shofer S, Mahmood K, Michaud G, Puchalski J, Rafeq S, Cattaneo SM, Mullon J, Leh S, Mayse M, Thomas SM, Peterson B, Light RW. Randomized Trial of Pleural Fluid Drainage Frequency in Patients with Malignant Pleural Effusions. The ASAP Trial. Am J Respir Crit Care Med. 2017 Apr 15;195(8):1050-1057. doi: 10.1164/rccm.201607-1404OC.
PubMed 27898215Lui MM, Thomas R, Lee YC. Complications of indwelling pleural catheter use and their management. BMJ Open Respir Res. 2016 Feb 5;3(1):e000123. doi: 10.1136/bmjresp-2015-000123. eCollection 2016.
PubMed 26870384Reddy C, Ernst A, Lamb C, Feller-Kopman D. Rapid pleurodesis for malignant pleural effusions: a pilot study. Chest. 2011 Jun;139(6):1419-1423. doi: 10.1378/chest.10-1868. Epub 2010 Oct 7.
PubMed 20930006Krochmal R, Reddy C, Yarmus L, Desai NR, Feller-Kopman D, Lee HJ. Patient evaluation for rapid pleurodesis of malignant pleural effusions. J Thorac Dis. 2016 Sep;8(9):2538-2543. doi: 10.21037/jtd.2016.08.55.
PubMed 27747006Boujaoude Z, Bartter T, Abboud M, Pratter M, Abouzgheib W. Pleuroscopic Pleurodesis Combined With Tunneled Pleural Catheter for Management of Malignant Pleural Effusion: A Prospective Observational Study. J Bronchology Interv Pulmonol. 2015 Jul;22(3):237-43. doi: 10.1097/LBR.0000000000000186.
PubMed 26165894Ahmed L, Ip H, Rao D, Patel N, Noorzad F. Talc pleurodesis through indwelling pleural catheters for malignant pleural effusions: retrospective case series of a novel clinical pathway. Chest. 2014 Dec;146(6):e190-e194. doi: 10.1378/chest.14-0394.
PubMed 25451360King MT. The interpretation of scores from the EORTC quality of life questionnaire QLQ-C30. Qual Life Res. 1996 Dec;5(6):555-67. doi: 10.1007/BF00439229.
PubMed 8993101Sivakumar P, Douiri A, West A, Rao D, Warwick G, Chen T, Ahmed L. OPTIMUM: a protocol for a multicentre randomised controlled trial comparing Out Patient Talc slurry via Indwelling pleural catheter for Malignant pleural effusion vs Usual inpatient Management. BMJ Open. 2016 Oct 18;6(10):e012795. doi: 10.1136/bmjopen-2016-012795.
PubMed 27798020Neto JD, de Oliveira SF, Vianna SP, Terra RM. Efficacy and safety of iodopovidone pleurodesis in malignant pleural effusions. Respirology. 2010 Jan;15(1):115-8. doi: 10.1111/j.1440-1843.2009.01663.x. Epub 2009 Nov 23.
PubMed 19947987Agarwal R, Paul AS, Aggarwal AN, Gupta D, Jindal SK. A randomized controlled trial of the efficacy of cosmetic talc compared with iodopovidone for chemical pleurodesis. Respirology. 2011 Oct;16(7):1064-9. doi: 10.1111/j.1440-1843.2011.01999.x.
PubMed 21605278Olivares-Torres CA, Laniado-Laborin R, Chavez-Garcia C, Leon-Gastelum C, Reyes-Escamilla A, Light RW. Iodopovidone pleurodesis for recurrent pleural effusions. Chest. 2002 Aug;122(2):581-3. doi: 10.1378/chest.122.2.581.
PubMed 12171835
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blinded, Controlled Trial of a Rapid Pleurodesis Protocol After Indwelling Pleural Catheter Placement for Malignant Pleural Effusions
- ClinicalTrials.gov ID
- NCT03325192
- Acronym / sponsor ID
- RAPID / 827688
- Conditions
- Pleural Effusion, Malignant, Pleurodesis, Pleural Diseases
- Keywords
- Indwelling Pleural Catheter, Pleurodesis, Iodopovidone, Pleural Effusion, Malignant
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 30 Oct 2017 (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 primary objective of the study is to evaluate whether the use of a rapid pleurodesis protocol using 10% iodopovidone immediately after tunneled pleural catheter placement improves time to IPC removal compared to patients who receive an IPC alone.
Detailed description
Patients will be screened throughout the year as part of the clinical referral process to the Interventional Pulmonology service at the Hospital of the University of Pennsylvania for the management of a malignant pleural effusion. Patients eligible for inclusion based on the clinical evaluation will be approached for enrollment. Written consent will be obtained. Patients will subsequently undergo placement of a IPC under MAC as per standard clinical practice followed by complete drainage of the pleural space. Patients randomized to the rapid pleurodesis protocol arm will received 20mL of 10% iodopovidone mixed with 80mL of normal saline instilled intrapleurally through the IPC. Patients randomized to the standard of care arm will have 100mL of normal saline (placebo) instilled intrapleurally through the IPC. The mixture will be allowed to dwell for 2 hours and then completely evacuated through the IPC and the patient will be discharged home.
After discharge, all patients will continue to drain their IPC on a daily basis for 7 days. Following this, all patients will continue to drain their IPC on an every-other-day basis until total IPC output is less than 50ml per session over 3 consecutive sessions. At which point they will be asked to undergo a clamp trial of no drainage for 7 days followed by a reattempt at drainage. Patients without return of symptoms over those 7 days and minimal drainage afterwards (<50ml) will be seen in the office for possible IPC removal. Patients with return of symptoms during those 7 days or more than minimal drainage afterwards (>50mL) will be asked to continue drainage until total IPC output is again less than 50mL per session over 3 sessions.
After a passed clamp trial, patients will be evaluated in the office with a bedside ultrasound to assess for pleural apposition in 5 of 6 designated points and the absence of pleural effusions. If all criteria are met, the IPC is removed. If there is evidence of residual effusion, continued drainage will be advised.
All patients will be evaluated in the office on day 7, day 14, day 30, day 60 and day 90 after IPC placement. On each visit they will be assessed for pleural apposition with ultrasound. At day 30, 60, and 90 all patients will receive a global health related questionnaire (EORTC QLQ30) and a symptom questionnaire. At 90 days, complications rate will be assessed for the entire study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, Randomized, Controlled, Double Blinded, Parallel Design, Trial
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Placebo comparator | Other: PlaceboSubjects in this arm will receive placebo only (100mL of normal saline) into the pleural space delivered via the newly placed tunneled intrapleural catheter |
| Rapid pleurodesis protocol | Experimental | Drug: Rapid pleurodesis protocolSubjects in this arm will receive the chemical pleurodesing agent of 10% iodopovidone solution delivered to the pleural space via the newly placed tunneled intrapleural catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of MPE as defined by
- Symptomatic from the pleural effusions (shortness of breath, cough, or chest pain)
- Prior thoracentesis with post procedure symptomatic relief
- Recurrence of symptoms with re-accumulation of pleural effusion
- Lung re-expansion after thoracentesis on chest imaging within last 30 days
Key exclusion criteria (12 listed)
- Malignant pleural effusion due to a hematologic malignancy
- ECOG >4
- Any history of trapped lung
- Prior attempted pleurodesis on the affected site
- Age <18
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 |
|---|---|---|
| Rapid pleurodesis protocolAlso: iodine pleurodesis* The pleural space will be evacuated completely through the newly placed IPC * 20mL of 10% iodopovidone and 80mL of normal saline will be instilled into the pleural space * The patient will be transferred to the recovery unit * Two hours after instillation the pleural space will be drained * After recovery from anesthesia and complete drainage of the pleurodesis mix, the subject will be discharged * Subjects will be asked to drain their effusion on a daily basis for the next 7 days and then on an every other day basis. | Drug | Rapid pleurodesis protocol |
| Placebo* The pleural space will be evacuated completely through the newly placed IPC * Only placebo (normal saline) will be instilled into the pleural space * The patient will be transferred to the recovery unit * Two hours after instillation the pleural space will be drained * After recovery from anesthesia and complete drainage of the pleurodesis mix, the subject will be discharged * Subjects will be asked to drain their effusion on a daily basis for the next 7 days and then on an every other day basis. | Other | Standard of care |
Primary outcome
Time to catheter removal
Time frame: 90 days
Time to IPC removal will be measured in days from the day of IPC placement to the day of IPC removal after meeting removal criteria as listed above.
4 secondary outcomes
Change in Global Health Related Quality of Life
Time frame: 30 days, 60 days, and 90 days after catheter placement
Change in symptoms of pain and breathlessness
Time frame: 30 days, 60 days, and 90 days after catheter placement
Time to return of clinically significant pleural effusion
Time frame: 90 days
Rate of successful pleurodesis at 90 days
Time frame: 90 days
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Background: PubMed 12728148Antunes G, Neville E, Duffy J, Ali N; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the management of malignant pleural effusions. Thorax. 2003 May;58 Suppl 2(Suppl 2):ii29-38. doi: 10.1136/thorax.58.suppl_2.ii29. 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 22610520Davies HE, Mishra EK, Kahan BC, Wrightson JM, Stanton AE, Guhan A, Davies CW, Grayez J, Harrison R, Prasad A, Crosthwaite N, Lee YC, Davies RJ, Miller RF, Rahman NM. Effect of an indwelling pleural catheter vs chest tube and talc pleurodesis for relieving dyspnea in patients with malignant pleural effusion: the TIME2 randomized controlled trial. JAMA. 2012 Jun 13;307(22):2383-9. doi: 10.1001/jama.2012.5535.
- 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 27898215Wahidi MM, Reddy C, Yarmus L, Feller-Kopman D, Musani A, Shepherd RW, Lee H, Bechara R, Lamb C, Shofer S, Mahmood K, Michaud G, Puchalski J, Rafeq S, Cattaneo SM, Mullon J, Leh S, Mayse M, Thomas SM, Peterson B, Light RW. Randomized Trial of Pleural Fluid Drainage Frequency in Patients with Malignant Pleural Effusions. The ASAP Trial. Am J Respir Crit Care Med. 2017 Apr 15;195(8):1050-1057. doi: 10.1164/rccm.201607-1404OC.
- Background: PubMed 26870384Lui MM, Thomas R, Lee YC. Complications of indwelling pleural catheter use and their management. BMJ Open Respir Res. 2016 Feb 5;3(1):e000123. doi: 10.1136/bmjresp-2015-000123. eCollection 2016.
- Background: PubMed 20930006Reddy C, Ernst A, Lamb C, Feller-Kopman D. Rapid pleurodesis for malignant pleural effusions: a pilot study. Chest. 2011 Jun;139(6):1419-1423. doi: 10.1378/chest.10-1868. Epub 2010 Oct 7.
- Background: PubMed 27747006Krochmal R, Reddy C, Yarmus L, Desai NR, Feller-Kopman D, Lee HJ. Patient evaluation for rapid pleurodesis of malignant pleural effusions. J Thorac Dis. 2016 Sep;8(9):2538-2543. doi: 10.21037/jtd.2016.08.55.
- Background: PubMed 26165894Boujaoude Z, Bartter T, Abboud M, Pratter M, Abouzgheib W. Pleuroscopic Pleurodesis Combined With Tunneled Pleural Catheter for Management of Malignant Pleural Effusion: A Prospective Observational Study. J Bronchology Interv Pulmonol. 2015 Jul;22(3):237-43. doi: 10.1097/LBR.0000000000000186.
- Background: PubMed 25451360Ahmed L, Ip H, Rao D, Patel N, Noorzad F. Talc pleurodesis through indwelling pleural catheters for malignant pleural effusions: retrospective case series of a novel clinical pathway. Chest. 2014 Dec;146(6):e190-e194. doi: 10.1378/chest.14-0394.
- Background: PubMed 8993101King MT. The interpretation of scores from the EORTC quality of life questionnaire QLQ-C30. Qual Life Res. 1996 Dec;5(6):555-67. doi: 10.1007/BF00439229.
- Background: PubMed 27798020Sivakumar P, Douiri A, West A, Rao D, Warwick G, Chen T, Ahmed L. OPTIMUM: a protocol for a multicentre randomised controlled trial comparing Out Patient Talc slurry via Indwelling pleural catheter for Malignant pleural effusion vs Usual inpatient Management. BMJ Open. 2016 Oct 18;6(10):e012795. doi: 10.1136/bmjopen-2016-012795.
- 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.
Kevin C Ma principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid pleurodesis protocol in people with Pleural Effusion, Malignant and Pleurodesis, run by University of Pennsylvania at 1 site 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 9 inclusion and 12 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: stopped early, as of the sponsor's last update on 8 May 2020. 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 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Slow enrollment). Results are not available in the source record.
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?
Time to catheter removal (time frame: 90 days). 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 NCT03325192, which also lists 17 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 8 May 2020.