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Malignant Pleural Effusion: Pleur-X vs. Chemical Pleurodesis in VATS (Pleur-X)

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. Identifier: NCT03518788
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Clinical Trial Unit Ente Ospedaliero Cantonale
Information provided by (Responsible Party):
Rolf Inderbitzi, Ente Ospedaliero Cantonale, Bellinzona

Brief Summary:

This is a prospective randomized study whose aim is to compare the efficacy of the permanent thoracic catheter (Pleur-X) versus chemical pleurodesis in videothoracoscopy (VATS) in the treatment of malignant pleural effusion at the first diagnosis.Patients with malignant pleural effusion for whom there is indication of surgery and who agree to participate in the study will be randomized 1: 1 in the Pleur-X arm (arm 1) or in the chemical pleurodesis arm (arm 2).

The arm 1 provides for the installation of a permanent drainage under local anesthesia while the arm 2 provides a pleurodesis with talc in VATS under general anesthesia.

Both procedures are standard of care.

Condition or disease Intervention/treatment Phase
Malignant Pleural Effusion Procedure: Pleur-X Procedure: Pleurodesis Not Applicable

Detailed Description:

Before the study procedure the patients will be requested to perform some examination as physical and radiological examination. Patients will also complete questionnaires for quality of life assessment (EORTC QLQ 30) and symptoms (VAS for pain). Patients will then be randomized into one of the two arms.

For patients included in arm 1, a permanent drainage (Pleur-X) is provided under local anesthesia performed on an outpatient basis while for patients included in arm 2 a pleurodesis with talc in VATS is planned under general anesthesia. Arm 2 patients will be hospitalized for 5 days.

Patients will then be followed up to 3 months after surgery. During this period a medical examination will be required at 1 week, 4 weeks and 3 months after the intervention during which the patient will be asked to complete questionnaires for the evaluation of quality of life (EORTC QLQ 30) and symptoms (VAS for pain ). A chest radiograph will be performed after four weeks to evaluate the primary parameter. Adverse events will be collected throughout the study period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial to Evaluate the Efficacy of the Permanent Thoracic Catheter (Pleur-X) Towards Pleurodesis in Thoracoscopy in the Treatment of Malignant Pleural Effusion
Actual Study Start Date : January 25, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Pleur-X
Placement of a permanent drainage under local anesthesia
Procedure: Pleur-X
Permanent drainage

Experimental: pleurodesis
Pleurodesis with talc in VATS
Procedure: Pleurodesis
Pleurodesis with talc in permanent VATS

Primary Outcome Measures :
  1. Success rate of the treatment with VPM [ Time Frame: 4 weeks ]
    Evaluate the success rate of the treatment with VPM with radiological examination

Secondary Outcome Measures :
  1. Adverse Event [ Time Frame: 3 months ]
    Evaluate the tollerability of both procedures collecting adverse events

  2. Quality of live [ Time Frame: 3 months ]
    quality of live will be determined with the evaluation of the EORTC QLQ 30 questionnaire

  3. Pain scale [ Time Frame: 3 months ]
    Pain will be evaluated with the Visual Analogue Scale (VAS) where the score of 0 is no pain while the score 10 is very painfull

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥ 18 years, <80 years
  • First diagnosis of malignant pleural effusion
  • Indication to treat the malignant pleural effusion with surgery
  • Informed informed consent

Exclusion Criteria:

  • Previous surgeries on the same hemitorace
  • Pregnant women
  • Trapped lung syndrome
  • Patients with estimated life expectancy < 4-8 weeks

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 identifier (NCT number): NCT03518788

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Contact: Rolf Inderbitzi, MD +41 (0)91 811 91 76
Contact: Stefano Cafarotti, MD +41 (0)91 811 93 40

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Ospedale San Giovanni Recruiting
Bellinzona, Switzerland, 6500
Contact: Rolf Inderbitzi, MD    +41 (0)91 811 91 76   
Contact: Stefano Cafarotti, MD    +41 (0)91 811 93 40   
Sponsors and Collaborators
Rolf Inderbitzi
Clinical Trial Unit Ente Ospedaliero Cantonale
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Study Director: Rolf Inderbitzi, MD Ente Ospedaliero Cantonale, Bellinzona

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Responsible Party: Rolf Inderbitzi, Head of thoracic surgery department, Ente Ospedaliero Cantonale, Bellinzona Identifier: NCT03518788     History of Changes
Other Study ID Numbers: ORBV-CHIR-001
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pleural Effusion, Malignant
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site