Indwelling Pleural Catheter for Trapped Lung

Not Applicable

Completed

• Conditions: Pleura; Effusion
• Interventions: Device: PleurX; Device: Pleurocath

• Registration Number: NCT03550027
• Lead Sponsor: European Institute of Oncology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-21
• Primary Completion: 2017-11-03
• Study Completion: 2018-02-15
• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-05-25
• Status Verified: 2018-06
• Study First Posted: 2018-06-08
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PleurX	PleurX	Positioning of Pleurx drainage during surgical exploration if lung does not reinflate
Pleurocath	Pleurocath	Positioning of Pleur o cath drainage during surgical exploration if lung does not reinflate

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Italy