UnknownNot Applicable

Talc Outpatient Pleurodesis With Indwelling Catheter

United States124 participantsStarted 2019-05-27

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Time to pleurodesis

Timeframe: Up to one month from placement of indwelling pleural catheter

Trial details

NCT IDNCT03973957

SponsorThe Cooper Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-31

Contact for this trial

Wissam Abouzgheib, MD

856-342-2406 abouzgheib-wissam@cooperhealth.edu