Talc Outpatient Pleurodesis With Indwelling Catheter (TOPIC)

Talc Outpatient Pleurodesis With Indwelling Catheter: A Randomized Controlled Trial

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).

Study Overview

• Status: Unknown
• Conditions: Pleural Diseases; Pleural Effusion; Malignant Pleural Effusion
• Intervention / Treatment: Device: Indwelling pleural catheter placement; Drug: Fentanyl Citrate; Drug: Talc Slurry; Device: Drainage collection bag

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.

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wissam Abouzgheib, MD; Phone Number: 856-342-2406; Email: abouzgheib-wissam@cooperhealth.edu

Study Locations

• United States
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Recruiting
      • Cooper University Hospital
      • Contact: Wissam Abouzgheib; Phone Number: 856-342-2406

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Indwelling pleural catheter placement; Indwelling pleural catheter placement by interventional pulmonologist; Other Names: IPC; Pleural catheter; Chest tube; Drug: Fentanyl Citrate; Administration of intravenous fentanyl prior to talc slurry instillation in order to avoid pain associated with talc slurry application; Other Names: "Pain medication"; 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
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).	Device: Indwelling pleural catheter placement; Indwelling pleural catheter placement by interventional pulmonologist; Other Names: IPC; Pleural catheter; Chest tube; Drug: Fentanyl Citrate; Administration of intravenous fentanyl prior to talc slurry instillation in order to avoid pain associated with talc slurry application; Other Names: "Pain medication"; 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; Device: 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.; Other Names: "Leg bag"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to pleurodesis	Will measure the time to pleurodesis in the individual arms	Up to one month from placement of indwelling pleural catheter

Collaborators and Investigators

• Sponsor: The Cooper Health System
• Investigators: Principal Investigator: Wissam Abouzgheib, Cooper Health System

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2019
• Primary Completion (Anticipated): January 31, 2021
• Study Completion (Anticipated): January 31, 2021

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: June 2, 2019
• First Posted (Actual): June 4, 2019

Study Record Updates

• Last Update Posted (Actual): June 4, 2019
• Last Update Submitted That Met QC Criteria: June 2, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Pleural effusion; Malignant pleural effusion; Pleurodesis; Pleural diseases
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion; Pleural Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: 19-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes