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OpenTrials
Completed

NCT Number: NCT03550027

Indwelling Pleural Catheter for Trapped Lung

Malignant pleural effusion (MPE) is a complication of almost any site of primary cancer as well as primary tumors of the pleura. Half of MPE patients have non-expendable trapped lungs not suitable for talc pleurodesis. Indwelling pleural catheters (IPCs), however, can be used in this cohort of patients, bringing about an improvement in dyspnea and quality of life (QOL).

The aim of this study is to obtain pilot data - comparing patients receiving two different types of indwelling pleural catethers normally used in clinical practice (10 patients receiving Pleurocath® and 10 patients receiving PleurX®) - for power calculation of a Randomized Controlled Trial comparing two different drainages for MPE trapped lung.

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Key information

Conditions

Pleura; Effusion Pleural Diseases Pleural Effusion Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

European Institute of Oncology

Milan, 20141, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients, with a clinical confident diagnosis of symptomatic malignant pleural effusion, enrolled for VATS exploration but not amenable of VATS talc poudrage because of trapped lung (patients with only partial expansion however receiving talc poudrage, but needing permanent pleural cathetes, are also eligible)

Exclusion criteria

  • - Age younger than 18 years
  • Expected survival of less than 3 months
  • Chylothorax
  • Total white blood cell count less than 1000/microL
  • Pregnancy or lactating mothers
  • Irreversible bleeding diathesis
  • Irreversible visual impairment
  • Contraindications to general anesthesia
  • Poor general clinical conditions ( ECOG PS >=2)
  • Patients unable to provide informed consent

Treatment and study plan

PleurX

Device

Positioning of drainage PleurX

Pleurocath

Device

Positioning of drainage Pleurocath

Primary outcomes

  1. Visual Analog Scale (VAS) range 0 (no pain) - 100 (maximum pain)

    Time frame: Post operative day 4th

    Thoracic pain

  2. Visual Analog Scale (VAS) range 0 (no dyspnea) - 100 (maximim dyspnea)

    Time frame: Post operative day 4th

    Dyspnea

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

Indwelling Pleural Catheter for Trapped Lung: a Pilot Study for Power Calculation of a Randomized Controlled Trial Comparing Pleurocath® Versus PleurX®)

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jun 8, 2018
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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