Clinical trial · Interventional
Talc Outpatient Pleurodesis With Indwelling Catheter
Talc Outpatient Pleurodesis With Indwelling Catheter: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will be a prospective, randomized trial comparing a new protocol to the standard of care. The investigators protocol and the standard of care involves a previously established procedure that will be completed in the investigators pulmonary procedure unit. The study will include using previously, well-established procedures (indwelling pleural catheter placement, talc slurry administration through an indwelling pleural catheter, pleuroscopy with talc poudrage administration) in addition to a new protocol (at home continuous drainage via indwelling pleural catheter).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Pleural Effusion | — | UNRESOLVED | — |
| Pleural Diseases | — | UNRESOLVED | — |
| Pleural Effusion | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drainage collection bag | Device | — | UNRESOLVED |
| Fentanyl Citrate | Drug | — | UNRESOLVED |
| Indwelling pleural catheter placement | Device | — | UNRESOLVED |
| Talc Slurry | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control Arm
- description
- 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.
- interventionNames
- Device: Indwelling pleural catheter placement
- Drug: Fentanyl Citrate
- Drug: Talc Slurry
- type
- ACTIVE_COMPARATOR
- label
- Intervention Arm
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available