Safety and Effectiveness of a New Pleural Catheter for Symptomatic, Recurrent, MPEs Versus Approved Pleural Catheter (SWIFT)

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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Pleural Effusion
• Intervention / Treatment: Device: Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC); Device: Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol, United Kingdom
    • Southmead Hospital
  • Oxford, United Kingdom
    • Oxford Center for Respiratory Medicine, Churchill Hospital
  • Swindon, United Kingdom
    • Great Western Hospital
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Heart Center Research
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine/ Stanford Cancer Institute
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Unversity
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Medical Group
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deconess Medical Center West
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington Universtiy School of Medicine, Barnes Jewish Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • New York
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Hospital
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbuilt University
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas, MD Anderson Cancer Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)	Device: Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC); Other Names: SNCIPC
ACTIVE_COMPARATOR: Approved Uncoated PleurX Indwelling Pleural Catheter	Device: Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Proportion of Subjects Achieving Pleurodesis Without Recurrence.	30 days post catheter insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Confirmed Pleurodesis		30 days post insertion
Time to Recurrence	This endpoint was meant to measure time to recurrence; however, only 1 participant (in the SNCIPC group) had a recurrence so this outcome could not be analyzed.	90 days post insertion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Surviving Subjects Without a Trapped Lung Diagnosis Following IPC Placement Who Have Confirmed Pleurodesis Without Recurrence at 14, 30, 60, 90 Days.		Day 14, Day 30, Day 60, Day 90
Proportion of Subjects With Confirmed Pleurodesis and Without Recurrence 30 Days After IPC Placement by Cancer Type (Lung, Breast and Others).		30 days.
Incidence of IPC Occlusion		90 days
Incidence of Empyema and Cellulitis		90 days
Pain Using 100 mm Visual Analog Scale (VAS)	Chest pain was measured using a 100 mm VAS scale at baseline and at each subsequent visit. The resulting VAS score ranges from 0 to 100, with 0 indicating "No pain" and 100 indicating "Very severe pain". Therefore, the lower the number, the less chest pain the subject is feeling at the time.	Baseline,Day 7, 14, 30, 45, 75, and 90

Collaborators and Investigators

• Sponsor: CareFusion
• Investigators: Principal Investigator: Joseph B Shrager, MD, Stanford University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (ACTUAL): April 18, 2018
• Study Completion (ACTUAL): April 18, 2018

Study Registration Dates

• First Submitted: December 18, 2015
• First Submitted That Met QC Criteria: January 6, 2016
• First Posted (ESTIMATE): January 8, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 10, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: malignant pleural effusion
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion; Anti-Infective Agents, Local; Anti-Infective Agents; Silver Nitrate
• Other Study ID Numbers: CS-IP-VH-14-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO