Indwelling Pleural Catheter for Trapped Lung

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03550027

Enrollment

Registered

2018-06-08

Start date

2017-04-21

Completion date

2018-02-15

Last updated

2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleura; Effusion

Brief summary

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.

Interventions

DEVICEPleurX

Positioning of drainage PleurX

DEVICEPleurocath

Positioning of drainage Pleurocath

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Visual Analog Scale (VAS) range 0 (no pain) - 100 (maximum pain)	Post operative day 4th	Thoracic pain
Visual Analog Scale (VAS) range 0 (no dyspnea) - 100 (maximim dyspnea)	Post operative day 4th	Dyspnea

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026