Talc Outpatient Pleurodesis With Indwelling Catheter

Pleural Effusion Clinical Trial

— TOPIC  

Official title:

Talc Outpatient Pleurodesis With Indwelling Catheter: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03973957
• Other study ID #: 19-020
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: June 2019
• Source: The Cooper Health System
• Contact: Wissam Abouzgheib, MD
• Phone: 856-342-2406
• Email: abouzgheib-wissam[@]cooperhealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Pleural Effusion
• Pleural Diseases
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Device:
• Indwelling pleural catheter placement
Indwelling pleural catheter placement by interventional pulmonologist

Drug:
• Fentanyl Citrate
Administration of intravenous fentanyl prior to talc slurry instillation in order to avoid pain associated with talc slurry application
• Talc Slurry
Administration of 5 grams of medical grade sterile talc mixed in 50 milliliters of normal saline solution via indwelling pleural catheter for purposes of talc slurry pleurodesis

Device:
• Drainage collection bag
Attachment of one-way Heimlich valve with drainage collection bag circuit to indwelling pleural catheter after talc slurry application for purposes of drainage and pleurodesis in the outpatient setting rather than the inpatient setting.

Locations

Country	Name	City	State
United States	Cooper University Hospital	Camden	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
The Cooper Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to pleurodesis	Will measure the time to pleurodesis in the individual arms	Up to one month from placement of indwelling pleural catheter