Talc Outpatient Pleurodesis With Indwelling Catheter

NCT ID: NCT03973957

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-27
• Study Completion Date: 2021-01-31

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.

Conditions

Pleural Effusion; Pleural Diseases; Malignant Pleural Effusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Indwelling pleural catheter placement

Intervention Type: DEVICE

Indwelling pleural catheter placement by interventional pulmonologist

Fentanyl Citrate

Intervention Type: DRUG

Administration of intravenous fentanyl prior to talc slurry instillation in order to avoid pain associated with talc slurry application

Talc Slurry

Intervention Type: DRUG

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

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).

Group Type: ACTIVE_COMPARATOR

Indwelling pleural catheter placement

Intervention Type: DEVICE

Indwelling pleural catheter placement by interventional pulmonologist

Fentanyl Citrate

Intervention Type: DRUG

Administration of intravenous fentanyl prior to talc slurry instillation in order to avoid pain associated with talc slurry application

Talc Slurry

Intervention Type: DRUG

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

Intervention Type: DEVICE

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.

Interventions

Indwelling pleural catheter placement

Indwelling pleural catheter placement by interventional pulmonologist

Intervention Type: DEVICE

Fentanyl Citrate

Administration of intravenous fentanyl prior to talc slurry instillation in order to avoid pain associated with talc slurry application

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Other Intervention Names

IPC; Pleural catheter; Chest tube; "Pain medication"; "Leg bag"

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Cooper Health System

OTHER

Sponsor Role: lead

Responsible Party

Wissam Abouzgheib

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wissam Abouzgheib

Role: PRINCIPAL_INVESTIGATOR

Cooper health system

Locations

Cooper University Hospital

Camden, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Wissam Abouzgheib, MD

Role: CONTACT

abouzgheib-wissam@cooperhealth.edu

856-342-2406

Facility Contacts

Wissam Abouzgheib

Role: primary

856-342-2406

Other Identifiers

19-020

Identifier Type: -

Identifier Source: org_study_id