Clinical trial NCT03973957: Talc Outpatient Pleurodesis With Indwelling Catheter
Official title: Talc Outpatient Pleurodesis With Indwelling Catheter: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pleural Effusion
Pleural Diseases
Malignant Pleural Effusion
Keywords: Pleural effusion
Pleural diseases
Pleurodesis
Malignant pleural effusion
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Randomized and controlled trial
Primary purpose: TREATMENT

Brief 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).

Detailed description: The study design is a prospective, randomized and controlled trial comparing a new protocol to the standard of care. To the investigators knowledge, there is no similar protocol and this will be a single center, pilot study. The control arm will consist of subjects who meet the inclusion criteria for the study and will receive current standard of care management for paramalignant pleural effusion. This will consist of either an indwelling pleural catheter (IPC) placement with subsequent talc slurry administration and hospital admission for continuous drainage, or schedule medical pleuroscopy with talc insufflation poudrage and subsequent IPC placement for continuous drainage while in the hospital. The intervention arm will consist of subjects who meet the inclusion criteria and then will be scheduled for IPC placement in the pulmonary procedure unit as either an outpatient visit or during their hospital admission (if the subject is already admitted to the hospital and recruited via our inpatient consult service). The subjects in this arm will then go home or back to their original admission status with a drainage bag for continuous drainage on the same day as the procedure. This protocol will utilize a circuit with an IPC connected to a continuous drainage bag via a one-way Heimlich valve. It is important to note that while utilizing this circuit is a new protocol for patients with paramalignant pleural effusions, the protocol is the current standard of care practice for patients with pneumothorax and persistent air leak, and is being utilized regularly for these patients by the investigator's department as standard of care for patient needing long-term chest tubes while at home.

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

Primary outcomes:
measure: Time to pleurodesis
timeFrame: Up to one month from placement of indwelling pleural catheter
Secondary outcomes:
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
Study officials:
affiliation: Cooper health system
name: Wissam Abouzgheib
role: PRINCIPAL_INVESTIGATOR
References: