Indwelling Pleural Catheter for Trapped Lung

European Institute of Oncology

Status: Completed

Conditions: Pleura; Effusion

Treatments: Device: PleurX; Device: Pleurocath

Study type: Interventional

Funder types: Other

Identifiers

NCT03550027

R 574/17 - IEO 607

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

PleurX

Experimental group

Description:

Positioning of Pleurx drainage during surgical exploration if lung does not reinflate

Treatment:

Device: PleurX

Pleurocath

Experimental group

Description:

Positioning of Pleur o cath drainage during surgical exploration if lung does not reinflate

Treatment:

Device: Pleurocath