Talc Outpatient Pleurodesis With Indwelling Catheter

• Status: Unknown status
• Trial end date: 2021-01-31
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Cooper Health System
• Treatments: Fentanyl

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