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

Last updated: April 25, 2018
Sponsor: Rolf Inderbitzi
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Disease

Pleural Effusion

Treatment

N/A

Clinical Study ID

NCT03518788
ORBV-CHIR-001
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Previous surgeries on the same hemitorace

  • Pregnant women

  • Trapped lung syndrome

  • Patients with estimated life expectancy < 4-8 weeks

Study Design

Total Participants: 234
Study Start date:
January 25, 2018
Estimated Completion Date:
December 31, 2020

Study 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.

Connect with a study center

  • Ospedale San Giovanni

    Bellinzona, 6500
    Switzerland

    Active - Recruiting

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