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Talc Outpatient Pleurodesis With Indwelling Catheter (TOPIC)

Primary Purpose

Pleural Effusion, Pleural Diseases, Malignant Pleural Effusion

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Indwelling pleural catheter placement
Fentanyl Citrate
Talc Slurry
Drainage collection bag
Sponsored by
The Cooper Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Effusion focused on measuring Pleural effusion, Pleural diseases, Pleurodesis, Malignant pleural effusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cooper University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control Arm

Intervention Arm

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Time to pleurodesis
Will measure the time to pleurodesis in the individual arms

Secondary Outcome Measures

Full Information

First Posted
May 27, 2019
Last Updated
June 2, 2019
Sponsor
The Cooper Health System
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1. Study Identification

Unique Protocol Identification Number
NCT03973957
Brief Title
Talc Outpatient Pleurodesis With Indwelling Catheter
Acronym
TOPIC
Official Title
Talc Outpatient Pleurodesis With Indwelling Catheter: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 27, 2019 (Actual)
Primary Completion Date
January 31, 2021 (Anticipated)
Study Completion Date
January 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cooper Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion, Pleural Diseases, Malignant Pleural Effusion
Keywords
Pleural effusion, Pleural diseases, Pleurodesis, Malignant pleural effusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, Randomized and controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention Arm
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Indwelling pleural catheter placement
Other Intervention Name(s)
IPC, Pleural catheter, Chest tube
Intervention Description
Indwelling pleural catheter placement by interventional pulmonologist
Intervention Type
Drug
Intervention Name(s)
Fentanyl Citrate
Other Intervention Name(s)
"Pain medication"
Intervention Description
Administration of intravenous fentanyl prior to talc slurry instillation in order to avoid pain associated with talc slurry application
Intervention Type
Drug
Intervention Name(s)
Talc Slurry
Intervention Description
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
Device
Intervention Name(s)
Drainage collection bag
Other Intervention Name(s)
"Leg bag"
Intervention Description
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 Information:
Title
Time to pleurodesis
Description
Will measure the time to pleurodesis in the individual arms
Time Frame
Up to one month from placement of indwelling pleural catheter

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wissam Abouzgheib, MD
Phone
856-342-2406
Email
abouzgheib-wissam@cooperhealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wissam Abouzgheib
Organizational Affiliation
Cooper health system
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wissam Abouzgheib
Phone
856-342-2406

12. IPD Sharing Statement

Plan to Share IPD
No

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Talc Outpatient Pleurodesis With Indwelling Catheter

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