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Impact of Indwelling Tunneled Pleural Drainage Systems (Gravity or Vacuum Based) on Pain in Patients with Recurrent Pleural Effusions
Trial Status: active
This trial studies the impact of indwelling tunneled pleural drainage systems (gravity or vacuum based) on pain in patients with plural effusion that has come back (recurrent). Vacuum drainage and gravity drainage are two commonly used drainage methods. Studying the best drainage methods may help future patients undergoing indwelling tunneled pleural catheter placement.
Inclusion Criteria
Clinical indications for placement of IPC for malignant pleural effusion
* Pleural effusion with symptomatic improvement in dyspnea after drainage of ipsilateral effusion
Clinically confident symptomatic malignant pleural effusion
* Histocytological proof of pleural malignancy
* Recurrent large pleural effusion in context of histologically proven cancer outside the pleural space
Plans for placement of IPC within ten days of enrollment
Sufficient fluid on ultrasound to allow for safe insertion of IPC
Exclusion Criteria
Recent (less than 60 days) thoracic surgery or chest trauma causing chronic pain
Pregnant or lactating mothers
Previous ipsilateral chemical pleurodesis
Current contralateral indwelling pleural catheter
Known rib or thoracic skeletal metastasis causing pain
Concern for active pleural infection
Respiratory failure
Irreversible bleeding diathesis
Inability to provide care for indwelling tunneled pleural catheter
Significantly loculated pleural space precluding drainage of pleural space, for which IPC alone will likely not offer symptomatic benefit
Estimated life expectancy of < 30 days (however, active enrollment in hospice program is not an exclusion criteria)
Inability to read/understand/write in the English language
Inability to follow-up for appointments/protocol
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
Enrollment in alternative pleural catheter trial that would preclude enrollment within this trial
Additional locations may be listed on ClinicalTrials.gov for NCT03831386.
I. The difference between the change in pain scores during indwelling tunneled pleural catheter (IPC) drainage via the vacuum bottle technique and IPC drainage via the gravity bag technique at two weeks after IPC placement.
SECONDARY OBJECTIVE:
II. Impact of the different drainage strategies on quality of life (as assessed by survey), pleurodesis rates, pain scores, days with drainage pain, dyspnea scores, complications, and patient outcomes.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo catheter placement over 15-30 minutes. Patients receive teaching specific to the vacuum drainage bottle during catheter insertion visit and then undergo vacuum drainage daily.
GROUP II: Patients undergo catheter placement over 15-30 minutes. Patients receive teaching specific to the gravity drainage bag during catheter insertion visit and then undergo gravity drainage daily.
After completion of study treatment, patients are followed up at 2 , 4, and 12 weeks and then periodically thereafter.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center