Talc Outpatient Pleurodesis With Indwelling Catheter

NCT03973957 | Unknown DMC FDA Device

• 1 other identifier: 19-020
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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

Keywords

Pleural effusion; Pleural diseases; Pleurodesis; Malignant pleural effusion

Outcome Measures

Primary Outcomes (1)

• Time to pleurodesis

  Will measure the time to pleurodesis in the individual arms

  Up to one month from placement of indwelling pleural catheter

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

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.

Device: Indwelling pleural catheter placement; Drug: Fentanyl Citrate; Drug: Talc Slurry

Intervention Arm

ACTIVE COMPARATOR

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).

Device: Indwelling pleural catheter placement; Drug: Fentanyl Citrate; Drug: Talc Slurry; Device: Drainage collection bag

Interventions

Indwelling pleural catheter placement DEVICE

Indwelling pleural catheter placement by interventional pulmonologist

Also known as: IPC, Pleural catheter, Chest tube

Control Arm; Intervention Arm

Fentanyl Citrate DRUG

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

Also known as: "Pain medication"

Control Arm; Intervention Arm

Talc Slurry 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

Control Arm; Intervention Arm

Drainage collection bag 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.

Also known as: "Leg bag"

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

RECRUITING

MeSH Terms

Conditions

Pleural Effusion; Pleural Diseases; Pleural Effusion, Malignant

Interventions

Chest Tubes; Fentanyl; Acetaminophen

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Wissam Abouzgheib

  Cooper health system

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wissam Abouzgheib, MD

CONTACT

856-342-2406; abouzgheib-wissam@cooperhealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: Prospective, Randomized and controlled trial

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: June 4, 2019
• Study Start: May 27, 2019
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: June 4, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)