Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Talc Outpatient Pleurodesis With Indwelling Catheter (TOPIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03973957
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Wissam Abouzgheib, The Cooper Health System

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).

Condition or disease Intervention/treatment Phase
Pleural Effusion Pleural Diseases Malignant Pleural Effusion Device: Indwelling pleural catheter placement Drug: Fentanyl Citrate Drug: Talc Slurry Device: Drainage collection bag Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, Randomized and controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Talc Outpatient Pleurodesis With Indwelling Catheter: A Randomized Controlled Trial
Actual Study Start Date : May 27, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

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 Name: "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 Name: "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 Name: "Leg bag"




Primary Outcome Measures :
  1. Time to pleurodesis [ Time Frame: Up to one month from placement of indwelling pleural catheter ]
    Will measure the time to pleurodesis in the individual arms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03973957


Contacts
Layout table for location contacts
Contact: Wissam Abouzgheib, MD 856-342-2406 abouzgheib-wissam@cooperhealth.edu

Locations
Layout table for location information
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Wissam Abouzgheib    856-342-2406      
Sponsors and Collaborators
The Cooper Health System
Investigators
Layout table for investigator information
Principal Investigator: Wissam Abouzgheib Cooper health system

Layout table for additonal information
Responsible Party: Wissam Abouzgheib, Physician, The Cooper Health System
ClinicalTrials.gov Identifier: NCT03973957     History of Changes
Other Study ID Numbers: 19-020
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Wissam Abouzgheib, The Cooper Health System:
Pleural effusion
Pleural diseases
Pleurodesis
Malignant pleural effusion

Additional relevant MeSH terms:
Layout table for MeSH terms
Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics