Talc Outpatient Pleurodesis With Indwelling Catheter

Last updated: June 2, 2019
Sponsor: The Cooper Health System
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pleural Effusion

Pleural Diseases

Lung Disease

Treatment

N/A

Clinical Study ID

NCT03973957
19-020
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age greater than or equal to 18 years old

  • Diagnosis of a paramalignant pleural effusion (defined as a recurrent pleural effusiondirectly 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

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 activeparamalignant pleural effusion

  • Estimated life expectancy less than 3 months

  • Active clinical heart failure

  • Inability to return for frequent follow up appointments

  • Current incarceration

Study Design

Total Participants: 124
Study Start date:
May 27, 2019
Estimated Completion Date:
January 31, 2021

Study 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.

Connect with a study center

  • Cooper University Hospital

    Camden, New Jersey 08103
    United States

    Active - Recruiting

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