Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Indwelling Pleural Catheter for Trapped Lung

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03550027
Recruitment Status : Completed
First Posted : June 8, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Francesco Petrella, European Institute of Oncology

Brief Summary:

Malignant pleural effusion (MPE) is a complication of almost any site of primary cancer as well as primary tumors of the pleura. Half of MPE patients have non-expendable trapped lungs not suitable for talc pleurodesis. Indwelling pleural catheters (IPCs), however, can be used in this cohort of patients, bringing about an improvement in dyspnea and quality of life (QOL).

The aim of this study is to obtain pilot data - comparing patients receiving two different types of indwelling pleural catethers normally used in clinical practice (10 patients receiving Pleurocath® and 10 patients receiving PleurX®) - for power calculation of a Randomized Controlled Trial comparing two different drainages for MPE trapped lung.


Condition or disease Intervention/treatment Phase
Pleura; Effusion Device: PleurX Device: Pleurocath Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Indwelling Pleural Catheter for Trapped Lung: a Pilot Study for Power Calculation of a Randomized Controlled Trial Comparing Pleurocath® Versus PleurX®)
Actual Study Start Date : April 21, 2017
Actual Primary Completion Date : November 3, 2017
Actual Study Completion Date : February 15, 2018

Arm Intervention/treatment
Experimental: PleurX
Positioning of Pleurx drainage during surgical exploration if lung does not reinflate
Device: PleurX
Positioning of drainage PleurX

Experimental: Pleurocath
Positioning of Pleur o cath drainage during surgical exploration if lung does not reinflate
Device: Pleurocath
Positioning of drainage Pleurocath




Primary Outcome Measures :
  1. Visual Analog Scale (VAS) range 0 (no pain) - 100 (maximum pain) [ Time Frame: Post operative day 4th ]
    Thoracic pain

  2. Visual Analog Scale (VAS) range 0 (no dyspnea) - 100 (maximim dyspnea) [ Time Frame: Post operative day 4th ]
    Dyspnea



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:   No
Criteria

Inclusion Criteria:

  • Adult patients, with a clinical confident diagnosis of symptomatic malignant pleural effusion, enrolled for VATS exploration but not amenable of VATS talc poudrage because of trapped lung (patients with only partial expansion however receiving talc poudrage, but needing permanent pleural cathetes, are also eligible)

Exclusion Criteria:

  • - Age younger than 18 years
  • Expected survival of less than 3 months
  • Chylothorax
  • Total white blood cell count less than 1000/microL
  • Pregnancy or lactating mothers
  • Irreversible bleeding diathesis
  • Irreversible visual impairment
  • Contraindications to general anesthesia
  • Poor general clinical conditions ( ECOG PS >=2)
  • Patients unable to provide informed consent

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): NCT03550027


Locations
Layout table for location information
Italy
European Institute of Oncology
Milan, Italy, 20141
Sponsors and Collaborators
European Institute of Oncology
Investigators
Layout table for investigator information
Principal Investigator: Francesco Petrella, MD, PhD European Institute of Oncology

Layout table for additonal information
Responsible Party: Francesco Petrella, Principal Investigator, European Institute of Oncology
ClinicalTrials.gov Identifier: NCT03550027     History of Changes
Other Study ID Numbers: R 574/17 - IEO 607
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases