Malignant Pleural Effusion: Pleur-X vs. Chemical Pleurodesis in VATS (Pleur-X)
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|ClinicalTrials.gov Identifier: NCT03518788|
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : May 8, 2018
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||234 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Placement of a permanent drainage under local anesthesia
Pleurodesis with talc in VATS
Pleurodesis with talc in permanent VATS
- Success rate of the treatment with VPM [ Time Frame: 4 weeks ]Evaluate the success rate of the treatment with VPM with radiological examination
- Adverse Event [ Time Frame: 3 months ]Evaluate the tollerability of both procedures collecting adverse events
- Quality of live [ Time Frame: 3 months ]quality of live will be determined with the evaluation of the EORTC QLQ 30 questionnaire
- 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
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): NCT03518788
|Contact: Rolf Inderbitzi, MD||+41 (0)91 811 91 email@example.com|
|Contact: Stefano Cafarotti, MD||+41 (0)91 811 93 firstname.lastname@example.org|
|Ospedale San Giovanni||Recruiting|
|Bellinzona, Switzerland, 6500|
|Contact: Rolf Inderbitzi, MD +41 (0)91 811 91 76 email@example.com|
|Contact: Stefano Cafarotti, MD +41 (0)91 811 93 40 firstname.lastname@example.org|
|Study Director:||Rolf Inderbitzi, MD||Ente Ospedaliero Cantonale, Bellinzona|