Indwelling Pleural Catheter for Trapped Lung

NCT ID: NCT03550027

Last Updated: 2024-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-21

Study Completion Date

2018-02-15

Brief Summary

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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

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Conditions

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Pleura; Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PleurX

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

Group Type EXPERIMENTAL

PleurX

Intervention Type DEVICE

Positioning of drainage PleurX

Pleurocath

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

Group Type EXPERIMENTAL

Pleurocath

Intervention Type DEVICE

Positioning of drainage Pleurocath

Interventions

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PleurX

Positioning of drainage PleurX

Intervention Type DEVICE

Pleurocath

Positioning of drainage Pleurocath

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francesco Petrella, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

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European Institute of Oncology

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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R 574/17 - IEO 607

Identifier Type: -

Identifier Source: org_study_id

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