RECRUITING

Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Malignant pleural effusion remains a debilitating complication of end stage cancer, which can be greatly improved by the introduction of the indwelling tunneled pleural catheter (IPC). However, there is no standard of care regarding drainage and limited data on the utility of different drainage techniques. In addition, many patients develop discomfort and chest pain during drainage. The investigators propose to evaluate gravity drainage and suction drainage on quality of life measures and outcomes.

Official Title

The Impact of a Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System on Pain: A Multicenter, Randomized Trial

Quick Facts

Study Start:2019-01-31
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03831386

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Clinical indications for placement of IPC for malignant pleural effusion
  2. * Clinically confident symptomatic malignant pleural effusion
  3. 1. Histocytological proof of pleural malignancy
  4. 2. Recurrent large pleural effusion in context of histologically proven cancer outside the pleural space
  5. * Plans for placement of IPC within ten days of enrollment
  6. * Age \> 17 years
  7. * Sufficient fluid on ultrasound to allow for safe insertion of IPC
  1. * Recent (less than 60 days) thoracic surgery or chest trauma causing chronic pain
  2. * Pregnant or lactating mothers
  3. * Previous ipsilateral chemical pleurodesis
  4. * Current contralateral indwelling pleural catheter
  5. * Known rib or thoracic skeletal metastasis causing pain
  6. * Concern for active pleural infection
  7. * Respiratory failure
  8. * Irreversible bleeding diathesis
  9. * Inability to provide care for indwelling tunneled pleural catheter
  10. * Significantly loculated pleural space precluding drainage of pleural space, for which IPC alone will likely not offer symptomatic benefit
  11. * Estimated life expectancy of \< 30 days (however, active enrollment in hospice program is not an exclusion criteria)
  12. * Inability to read/understand/write in the English language
  13. * Inability to follow-up for appointments/protocol
  14. * 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.
  15. * Enrollment in alternative pleural catheter trial that would preclude enrollment within this trial

Contacts and Locations

Study Contact

IP Research
CONTACT
410-502-2533
IPresearch@jhmi.edu

Principal Investigator

Lonny Yarmus, DO
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Northwest Community Healthcare
Arlington Heights, Illinois, 60005
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Swedish Medical Center
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Lonny Yarmus, DO, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-01-31
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2019-01-31
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Pleural Effusion