Clinical trial NCT02649894: Safety and Effectiveness of a New Pleural Catheter for Symptomatic, Recurrent, MPEs Versus Approved Pleural Catheter
Official title: Pivotal Multi Center, Randomized, Controlled, Single-Blinded Study Comparing the Silver Nitrate Coated Indwelling Pleural Catheter to the Uncoated PleurX Catheter for the Management of Symptomatic, Recurrent, Malignant Pleural Effusions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Pleural Effusion
Keywords: malignant pleural effusion
Lead sponsor: CareFusion
Sponsor class: INDUSTRY
First posted: 2016-01-08
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a new catheter is safe and effective in treating malignant pleural effusions compared to approve catheter.


Eligibility criteria: Inclusion Criteria:

* 1. Male or female, at least 18 years of age, inclusive. 2. Subject has a symptomatic MPE requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true:

  1. There is histocytological confirmation of pleural malignancy
  2. The effusion is an exudate (per Light's criteria) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified.

     3. Subject has a history of at least 1 ipsilateral pleural effusion causing dyspnea that responded to thoracentesis where the lung expanded and the dyspnea was improved.

     4. Subject is willing and able to provide written informed consent. 5. Subject is willing and able to meet all study requirements, including follow-up visits and receiving study-related telephone calls.

     6. Subject has sufficient pleural fluid to allow safe insertion of an IPC. 7. Subject has negative pregnancy test if appropriate. 8. Subject or caregiver is able to perform home drainage of the pleural effusion (a caregiver can be a friend, family member or paid healthcare professional and applies to US sites only; UK subjects will have drainage managed by home-care nurses).

     Exclusion Criteria:
* 1. Subject has significant trapped lung, or a proximal bronchial obstruction which is likely to lead to trapped lung. For a subject to be eligible for this study, 2 separate study center clinicians must agree that there is no significant trapped lung on the same CXR using visual estimation (reference guide). The CXR used to make this decision must have been performed ≤30 days preceding the consent form being signed, and must have been performed preferably on the same day, but no more than 7 calendar days after a pleural drainage.

Significant trapped lung is deemed present if any 1 of the following criteria is met:

1. A CXR shows hydropneumothorax.
2. A CXR shows ≥20% of the affected hemithorax to be free of the expected lung parenchymal markings and there is no suggestion of pleural fluid.
3. A CXR shows ≥20% of the affected hemithorax to be occupied with pleural fluid AFTER a pleural aspiration which resulted in symptoms suggestive of trapped lung (e.g., chest pain or cough).

   2. Subject has a Karnofsky score \<50, or a World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) performance status ≥3. Subjects who have a performance status of 3 may be considered for the study if the removal of their fluid would likely improve their performance score by 1 or more.

   3. Subject is pregnant, planning to become pregnant, or is lactating. 4. Subject has a history of empyema. 5. Subject has a history of chylothorax. 6. Subject has an uncorrected coagulopathy. 7. Subject has a hypersensitivity to new or existing pleural catheter or it's components.

   8. Subject has evidence, in the opinion of the Investigator, of either on-going systemic or pleural infection.

   9. Subject has had a lobectomy or pneumonectomy on the side of the effusion. 10. Subject has undergone a previous attempt at ipsilateral pleurodesis which has failed.

   11. Subject has previously been diagnosed with a serious immunodeficiency disorder.

   12. Subject has bilateral pleural effusions, with both being at least moderate in size (greater than one-third of the hemithorax on CXR).

   13. Subject has evidence of fluid loculation such that attempts at pleurodesis are likely to be futile.

   14. Subject has a mediastinal shift of ≥2 cm toward the side of the effusion. 15. Subject is receiving concurrent intrapleural chemotherapy or radiation therapy to the ipsilateral chest.

   16. Subject has any clinical condition, diagnosis, or social circumstance that, in the opinion of the Investigator, would mean participation in the study would be contraindicated.

   17. Subject has no access to a telephone. 18. Subject has no documented blood values (complete blood count \[CBC\], coagulation tests, urea and electrolytes, and liver function tests \[LFTs\]) within the last 10 days.

   19. Subject has previously participated in any clinical trial with the investigational device.

   20. Subject currently enrolled in any other clinical investigation or who has participated in any clinical investigation in the 30 days prior to starting this study.

Primary outcomes:
measure: The Proportion of Subjects Achieving Pleurodesis Without Recurrence.
timeFrame: 30 days post catheter insertion
Secondary outcomes:
measure: Time to Confirmed Pleurodesis
timeFrame: 30 days post insertion
measure: Time to Recurrence
timeFrame: 90 days post insertion
Other outcomes:
measure: Proportion of Surviving Subjects Without a Trapped Lung Diagnosis Following IPC Placement Who Have Confirmed Pleurodesis Without Recurrence at 14, 30, 60, 90 Days.
timeFrame: Day 14, Day 30, Day 60, Day 90
measure: Proportion of Subjects With Confirmed Pleurodesis and Without Recurrence 30 Days After IPC Placement by Cancer Type (Lung, Breast and Others).
timeFrame: 30 days.
measure: Incidence of IPC Occlusion
timeFrame: 90 days
measure: Incidence of Empyema and Cellulitis
timeFrame: 90 days
measure: Pain Using 100 mm Visual Analog Scale (VAS)
timeFrame: Baseline,Day 7, 14, 30, 45, 75, and 90
Locations:
city: Huntsville
country: United States
facility: Heart Center Research
state: Alabama
city: Stanford
country: United States
facility: Stanford University School of Medicine/ Stanford Cancer Institute
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: Northwestern Unversity
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Medical Group
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deconess Medical Center West
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington Universtiy School of Medicine, Barnes Jewish Hospital
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Syracuse
country: United States
facility: SUNY Upstate Hospital
state: New York
city: Chapel Hill
country: United States
facility: UNC Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Nashville
country: United States
facility: Vanderbuilt University
state: Tennessee
city: Houston
country: United States
facility: University of Texas, MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Oxford
country: United Kingdom
facility: Oxford Center for Respiratory Medicine, Churchill Hospital
city: Swindon
country: United Kingdom
facility: Great Western Hospital
Study officials:
affiliation: Stanford University
name: Joseph B Shrager, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shrager JB, Bhatnagar R, Kearney CT, Retzlaff NP, Cohen E, Stanton AE, Keyes C, Wahidi MM, Gillespie C, Rahman N, Kerry AL, Feller-Kopman D, Nader D, Akulian J, Chen A, Berry M, Majid A, Reddy C, Tremblay A, Maskell NA. Silver Nitrate-coated versus Standard Indwelling Pleural Catheter for Malignant Effusions: The SWIFT Randomized Trial. Ann Am Thorac Soc. 2022 Oct;19(10):1722-1729. doi: 10.1513/AnnalsATS.202111-1301OC.