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

Not Applicable

• Conditions: Malignant Pleural Effusion
• Interventions: Procedure: Pleurodesis; Procedure: Pleur-X

• Registration Number: NCT03518788
• Lead Sponsor: Rolf Inderbitzi

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.

Study Timeline

• Study Start: 2018-01-25
• Status Verified: 2018-04
• Study First Submitted: 2018-04-06
• Study First Submitted QC: 2018-04-25
• Last Update Submitted: 2018-04-25
• Study First Posted: 2018-05-08
• Last Update Posted: 2018-05-08
• Primary Completion: 2020-03-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 234

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pleurodesis	Pleurodesis	Pleurodesis with talc in VATS
Pleur-X	Pleur-X	Placement of a permanent drainage under local anesthesia

Primary Outcome Measures

Name	Time	Method
Success rate of the treatment with VPM	4 weeks	Evaluate the success rate of the treatment with VPM with radiological examination

Secondary Outcome Measures

Name	Time	Method
Adverse Event	3 months	Evaluate the tollerability of both procedures collecting adverse events
Quality of live	3 months	quality of live will be determined with the evaluation of the EORTC QLQ 30 questionnaire
Pain scale	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

Trial Locations

Locations (1)

Ospedale San Giovanni; 🇨🇭 Bellinzona, Switzerland