Clinical trial NCT03518788: Malignant Pleural Effusion: Pleur-X vs. Chemical Pleurodesis in VATS
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malignant Pleural Effusion
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
Collaborators: name: Clinical Trial Unit Ente Ospedaliero Cantonale
First posted: 2018-05-08
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Success rate of the treatment with VPM
timeFrame: 4 weeks
Secondary outcomes:
measure: Adverse Event
timeFrame: 3 months
measure: Quality of live
timeFrame: 3 months
measure: Pain scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Ospedale San Giovanni
Study officials:
affiliation: Ente Ospedaliero Cantonale, Bellinzona
name: Rolf Inderbitzi, MD
role: STUDY_DIRECTOR
References: