Management of Malignant Pleural Effusions Using an Indwelling Tunneled Pleural Catheter and Non-Vacuum Collection System

  • STATUS
    Recruiting
  • End date
    Oct 31, 2024
  • participants needed
    40
  • sponsor
    Washington University School of Medicine
Updated on 28 February 2022
drainage
cancer
dyspnea
serum protein
pleurodesis
pleural fluid analysis
malignant pleural effusion

Summary

Indwelling tunneled pleural catheters have been successfully used to palliate dyspnea associated with recurrent malignant pleural effusions with few complications and spontaneous pleurodesis occurring in 30-50% of patients when using vacuum assisted drainage systems. Notably, all data on palliation of dyspnea as well as on rates of spontaneous pleurodesis have been performed using indwelling tunneled pleural catheters with vacuum assisted drainage systems. No current data exists regarding the efficacy, complications or rate of spontaneous pleurodesis when using indwelling tunneled pleural catheters and non-vacuum assisted drainage systems. This study is designed to evaluate an indwelling tunneled pleural catheter with a non-vacuum assisted drainage system for the management of recurrent malignant pleural effusions.

Details
Condition Malignant Pleural Effusion
Treatment ultrasound, Aspira Catheter
Clinical Study IdentifierNCT03414905
SponsorWashington University School of Medicine
Last Modified on28 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female, at least 18 years of age, inclusive
Subject has a symptomatic malignant pleural effusion requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true
There is cytological confirmation of pleural malignancy
The effusion is an exudate (per Light's criteria Pleural fluid protein/Serum protein >0.5, Pleural fluid LDH/Serum LDH >0.6, or Pleural fluid LDH >2/3 the upper limit of normal) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified
Subject is able to provide informed consent
Subject is willing and able to meet study requirements, including follow up visits
Subject has sufficient pleural fluid to allow safe insertion of an indwelling tunneled pleural catheter as determined by the PI
Subject is able to perform home drainage of the pleural effusion or has sufficient resources (family member, caregiver, home health)

Exclusion Criteria

Patients who refuse to participate
Are less than 18 years of age
Are pregnant
Are unable to provide informed consent
Subject has evidence, in the opinion of the PI, of either ongoing systemic or pleural infection
Subjects with uncorrected coagulopathy
All patients whom do not have malignant pleural effusions as outlined in the "definitions" section
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