Rapid Pleurodesis Through an Indwelling Pleural Catheter
NCT ID: NCT03325192
Last Updated: 2020-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
11 participants
INTERVENTIONAL
2017-12-12
2019-07-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Talc Outpatient Pleurodesis With Indwelling Catheter
NCT03973957
Out Patient Talc Slurry Via Indwelling Pleural Catheter for Malignant Pleural Effusion Vs Usual Inpatient Management
NCT02517749
Betadine Pleurodesis Via Tunneled Pleural Catheters
NCT02975921
Indwelling Pleural Catheter With Either Doxycycline or Saline at Day 7 for Pleurodesis
NCT02623959
Malignant Pleural Effusion: Pleur-X vs. Chemical Pleurodesis in VATS
NCT03518788
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Subjects will be blinded to their group assignment to minimize bias on follow up surveys.
Physicians evaluating the patient during the initial visit and on subsequent postprocedure followup will be blinded to subject assignment. The provider responsible for placement of the catheter and delivery of the pleurodesis agent or placebo will not be involved in post procedure followup care
All treatment physicians will follow prespecified protocols in deciding on adequate pleurodesis and timing of IPC removal.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard of care
Subjects in this arm will receive placebo only (100mL of normal saline) into the pleural space delivered via the newly placed tunneled intrapleural catheter
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.
Rapid pleurodesis protocol
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
Rapid pleurodesis protocol
* 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rapid pleurodesis protocol
* 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.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. A diagnosis a pleural effusion in the setting of known malignancy. AND
2. Confirmed malignant involvement of the pleural space by fluid cytology or pleural biopsy. OR
3. Evidence of pleural disease on radiographic imaging. OR
4. A recurrent effusion with no other identifiable cause after thorough workup.
2. Symptomatic from the pleural effusions (shortness of breath, cough, or chest pain)
3. Prior thoracentesis with post procedure symptomatic relief
4. Recurrence of symptoms with re-accumulation of pleural effusion
5. Lung re-expansion after thoracentesis on chest imaging within last 30 days
Exclusion Criteria
2. ECOG \>4
3. Any history of trapped lung
4. Prior attempted pleurodesis on the affected site
5. Age \<18
6. Pregnant or lactating
7. Known allergy to iodopovidone (Betadine)
8. Unable or unwilling to provide consent
9. Uncorrectable coagulopathy (INR \> 1.5, aPTT \> 1.5 x the upper limit of normal) or thrombocytopenia (\< 50,000)
10. Anatomic contraindication to IPC (overlying skin abnormalities)
11. Unable or unwilling to care for IPC and adhere to drainage protocol
12. Need for bilateral IPC placement
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Pennsylvania
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kevin Ma, MD
Assistant Professor of Clinical Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kevin C Ma
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
American 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.
Davies 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.
Roberts 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.
Wahidi 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.
Lui 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.
Reddy 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.
Krochmal 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.
Boujaoude 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.
Ahmed 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.
King 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.
Sivakumar 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.
Neto 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.
Agarwal 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.
Olivares-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.
Godazandeh G, Qasemi NH, Saghafi M, Mortazian M, Tayebi P. Pleurodesis with povidone-iodine, as an effective procedure in management of patients with malignant pleural effusion. J Thorac Dis. 2013 Apr;5(2):141-4. doi: 10.3978/j.issn.2072-1439.2013.02.02.
Agarwal R, Aggarwal AN, Gupta D, Jindal SK. Efficacy and safety of iodopovidone in chemical pleurodesis: a meta-analysis of observational studies. Respir Med. 2006 Nov;100(11):2043-7. doi: 10.1016/j.rmed.2006.02.009. Epub 2006 Mar 30.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
827688
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.