Talc Outpatient Pleurodesis With Indwelling Catheter — TOPIC  

Pleural Effusion Clinical Trial

Official title: Talc Outpatient Pleurodesis With Indwelling Catheter: A Randomized Controlled Trial

Status Recruiting

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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT03973957
• Study type: Interventional
• Source: The Cooper Health System
• Contact: Wissam Abouzgheib, MD
• Phone: 856-342-2406
• Email: abouzgheib-wissam@cooperhealth.edu
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2019
• Completion date: January 31, 2021