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

R

Rolf Inderbitzi

Status

Unknown

Conditions

Malignant Pleural Effusion

Treatments

Procedure: Pleur-X
Procedure: Pleurodesis

Study type

Interventional

Funder types

Other

Identifiers

NCT03518788
ORBV-CHIR-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

234 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

234 participants in 2 patient groups

Pleur-X
Experimental group
Description:
Placement of a permanent drainage under local anesthesia
Treatment:
Procedure: Pleur-X
pleurodesis
Experimental group
Description:
Pleurodesis with talc in VATS
Treatment:
Procedure: Pleurodesis

Trial contacts and locations

1

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Central trial contact

Rolf Inderbitzi, MD; Stefano Cafarotti, MD

Data sourced from clinicaltrials.gov

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