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

Malignant Pleural Effusion Clinical Trial

— Pleur-X  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03518788
• Other study ID #: ORBV-CHIR-001
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2018
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: Rolf Inderbitzi, MD
• Phone: +41 (0)91 811 91 76
• Email: rolf.inderbitzi[@]eoc.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: December 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Procedure:
• Pleur-X
Permanent drainage
• Pleurodesis
Pleurodesis with talc in permanent VATS

Locations

Country	Name	City	State
Switzerland	Ospedale San Giovanni	Bellinzona

Sponsors (2)

Lead Sponsor	Collaborator
Rolf Inderbitzi	Clinical Trial Unit EOC

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of the treatment with VPM	Evaluate the success rate of the treatment with VPM with radiological examination	4 weeks
Secondary	Adverse Event	Evaluate the tollerability of both procedures collecting adverse events	3 months
Secondary	Quality of live	quality of live will be determined with the evaluation of the EORTC QLQ 30 questionnaire	3 months
Secondary	Pain scale	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	3 months