Recruiting

Talc Pleurodesis

Sponsor:

The Cooper Health System

Code:

NCT03973957

Conditions

Pleural Effusion

Pleural Diseases

Malignant Pleural Effusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Indwelling pleural catheter placement

Fentanyl Citrate

Talc Slurry

Drainage collection bag

Study Details

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).

Conditions

Pleural Effusion

Pleural Diseases

Malignant Pleural Effusion

Study ID

NCT03973957

Start date

May 27, 2019

Status verified date

Jun, 2019

Completion date

Jan 31, 2021

Anticipated

Primary completion date

Jan 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

124 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control Arm

If undergoing talc slurry in the control arm, the patient will undergo IPC placement in the pulmonary procedure unit on day one of admission. The IPC will then be connected to a pleur-evac as standard of care protocol for chest tube drainage. At 1-2 hours post-IPC placement a chest x-ray will be obtained to assess for full lung re-expansion. If the lung does not fully expand the patient will be excluded from the study. Once full lung re-expansion has occurred, talc slurry will be ordered and the patient will be given 25 mcg of IV fentanyl. Talc slurry (5 g sterile talc, brand name Steritalc, mixed with 50 cc or sterile normal saline in a syringe, per Cooper University Pharmacy protocol) will be administered via the IPC. The patient will remain in the hospital, with continuous drainage measured daily for 2-5 days, depending on drainage of the effusion.

active comparator: Intervention Arm

An indwelling pleural catheter (IPC) will be placed during this visit. After complete drainage of the effusion, a chest x-ray will be done to determine if full lung reexpansion occurs. If there is lack of full lung re-expansion the patient will be excluded from the study at this time. If full lung re-expansion is present, the patient will receive an intravenous line (IV) by our nursing staff for analgesia prior to talc administration and will be pre-treated with 25 mcg of IV fentanyl.

Talc slurry (5 g sterile talc, brand name Steritalc, mixed with 50 cc or sterile normal saline in a syringe, per Cooper University Pharmacy protocol) will then be administered through the IPC. The IPC will then be connected to a circuit that will consist of the IPC connected to a 4-liter fluid drainage collection bag via a one-way Heimlich valve (picture of set up included in additional documents).

Interventions

Indwelling pleural catheter placement

Indwelling pleural catheter placement by interventional pulmonologist

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

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.

Primary outcome measure

  • Time to pleurodesis [ Time Frame: Up to one month from placement of indwelling pleural catheter ]

Central Contacts and Locations

Central contacts

Locations

Cooper University Hospital

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Wissam Abouzgheib

856-342-2406

More Information

Sponsor

The Cooper Health System

Last update posted

Jun 4, 2019

Last verified

Jun, 2019

Keywords

  • Pleural effusion
  • Pleural diseases
  • Pleurodesis
  • Malignant pleural effusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cooper Health System on 2019-06-04.