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出境医 / 临床实验 / Talc Outpatient Pleurodesis With Indwelling Catheter (TOPIC)

Talc Outpatient Pleurodesis With Indwelling Catheter (TOPIC)

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).

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.
Study Design
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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
Arms and Interventions
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"

Outcome Measures
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


Eligibility Criteria
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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
Contacts and Locations

Contacts
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Contact: Wissam Abouzgheib, MD 856-342-2406 abouzgheib-wissam@cooperhealth.edu

Locations
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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
Tracking Information
First Submitted Date  ICMJE May 27, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date June 4, 2019
Actual Study Start Date  ICMJE May 27, 2019
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Talc Outpatient Pleurodesis With Indwelling Catheter
Official Title  ICMJE Talc Outpatient Pleurodesis With Indwelling Catheter: A Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective, Randomized and controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pleural Effusion
  • Pleural Diseases
  • Malignant Pleural Effusion
Intervention  ICMJE
  • 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"
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Indwelling pleural catheter placement
    • Drug: Fentanyl Citrate
    • Drug: Talc Slurry
  • 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).

    Interventions:
    • Device: Indwelling pleural catheter placement
    • Drug: Fentanyl Citrate
    • Drug: Talc Slurry
    • Device: Drainage collection bag
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 2, 2019)
124
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2021
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03973957
Other Study ID Numbers  ICMJE 19-020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wissam Abouzgheib, The Cooper Health System
Study Sponsor  ICMJE The Cooper Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wissam Abouzgheib Cooper health system
PRS Account The Cooper Health System
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP