Rapid Pleurodesis Through an Indwelling Pleural Catheter

NCT03325192 | Terminated

• 1 other identifier: 827688
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pleural Effusion, Malignant; Pleurodesis; Pleural Diseases

Keywords

Indwelling Pleural Catheter; Pleurodesis; Iodopovidone; Pleural Effusion, Malignant

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Secondary Outcomes (4)

• Change in Global Health Related Quality of Life

  30 days, 60 days, and 90 days after catheter placement

• Change in symptoms of pain and breathlessness

  30 days, 60 days, and 90 days after catheter placement

• Time to return of clinically significant pleural effusion

  90 days

• Rate of successful pleurodesis at 90 days

  90 days

Study Arms (2)

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

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

Drug: Rapid pleurodesis protocol

Interventions

Rapid pleurodesis protocol DRUG

* 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.

Also known as: iodine pleurodesis

Rapid pleurodesis protocol

Placebo OTHER

* 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.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (17)

• 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.

  PMID: 12728148 BACKGROUND

• 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.

  PMID: 11069845 BACKGROUND

• 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.

  PMID: 22610520 BACKGROUND

• 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.

  PMID: 20696691 BACKGROUND

• 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.

  PMID: 27898215 BACKGROUND

• 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.

  PMID: 26870384 BACKGROUND

• 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.

  PMID: 20930006 BACKGROUND

• 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.

  PMID: 27747006 BACKGROUND

• 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.

  PMID: 26165894 BACKGROUND

• 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.

  PMID: 25451360 BACKGROUND

• 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.

  PMID: 8993101 BACKGROUND

• 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.

  PMID: 27798020 BACKGROUND

• 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.

  PMID: 19947987 BACKGROUND

• 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.

  PMID: 21605278 BACKGROUND

• 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.

  PMID: 12171835 BACKGROUND

• 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.

  PMID: 23585939 BACKGROUND

• 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.

  PMID: 16574389 BACKGROUND

MeSH Terms

Conditions

Pleural Effusion, Malignant; Pleural Diseases

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Respiratory Tract Diseases

Study Officials

• Kevin C Ma

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subject assignment will be done using randomly generated assignment tables based on stratification by tumor type (Lung, Breast, Other) and assigned 1:1 using random permuted blocks of 4. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Model Details: Prospective, Randomized, Controlled, Double Blinded, Parallel Design, Trial

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 30, 2017
• Study Start: December 12, 2017
• Primary Completion: July 9, 2019
• Study Completion: July 9, 2019
• Last Updated: May 8, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)