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

NCT03518788 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2018-05-08

No results posted yet for this 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.

Conditions

  • Malignant Pleural Effusion

Interventions

PROCEDURE

Pleur-X

Permanent drainage

PROCEDURE

Pleurodesis

Pleurodesis with talc in permanent VATS

Sponsors & Collaborators

  • Clinical Trial Unit Ente Ospedaliero Cantonale

    collaborator OTHER

  • Rolf Inderbitzi

    lead OTHER

Principal Investigators

  • Rolf Inderbitzi, MD · Ente Ospedaliero Cantonale, Bellinzona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-25
Primary Completion
2020-03-31
Completion
2020-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03518788 on ClinicalTrials.gov