Talc Outpatient Pleurodesis With Indwelling Catheter (TOPIC)
Pleural Effusion, Pleural Diseases, Malignant Pleural Effusion
About this trial
This is an interventional treatment trial for Pleural Effusion focused on measuring Pleural effusion, Pleural diseases, Pleurodesis, Malignant pleural effusion
Eligibility Criteria
Inclusion Criteria:
- Age greater than or equal to 18 years old
- Diagnosis of a paramalignant pleural effusion (defined as a recurrent pleural effusion directly caused by malignancy with known thoracic involvement)
- Estimated life expectancy greater than 3 months
- Full lung re-expansion on chest x-ray after thoracentesis
Exclusion Criteria:
- Age less than 18 years old
- Pregnant or lactating subject
- Any history of prior pleural talc administration
- History of an indwelling pleural catheter placed on the side of the active paramalignant pleural effusion
- Estimated life expectancy less than 3 months
- Active clinical heart failure
- Inability to return for frequent follow up appointments
- Current incarceration
Sites / Locations
- Cooper University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Control Arm
Intervention Arm
If undergoing talc slurry in the control arm, the patient will undergo IPC placement in the pulmonary procedure unit on day one of admission. The IPC will then be connected to a pleur-evac as standard of care protocol for chest tube drainage. At 1-2 hours post-IPC placement a chest x-ray will be obtained to assess for full lung re-expansion. If the lung does not fully expand the patient will be excluded from the study. Once full lung re-expansion has occurred, talc slurry will be ordered and the patient will be given 25 mcg of IV fentanyl. Talc slurry (5 g sterile talc, brand name Steritalc, mixed with 50 cc or sterile normal saline in a syringe, per Cooper University Pharmacy protocol) will be administered via the IPC. The patient will remain in the hospital, with continuous drainage measured daily for 2-5 days, depending on drainage of the effusion.
An indwelling pleural catheter (IPC) will be placed during this visit. After complete drainage of the effusion, a chest x-ray will be done to determine if full lung reexpansion occurs. If there is lack of full lung re-expansion the patient will be excluded from the study at this time. If full lung re-expansion is present, the patient will receive an intravenous line (IV) by our nursing staff for analgesia prior to talc administration and will be pre-treated with 25 mcg of IV fentanyl. Talc slurry (5 g sterile talc, brand name Steritalc, mixed with 50 cc or sterile normal saline in a syringe, per Cooper University Pharmacy protocol) will then be administered through the IPC. The IPC will then be connected to a circuit that will consist of the IPC connected to a 4-liter fluid drainage collection bag via a one-way Heimlich valve (picture of set up included in additional documents).