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Indwelling Pleural Catheter for Trapped Lung

Primary Purpose

Pleura; Effusion

Status

Completed

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

PleurX

Pleurocath

About this trial

This is an interventional treatment trial for Pleura; Effusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

European Institute of Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

PleurX

Pleurocath

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Thoracic pain

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

Dyspnea

Secondary Outcome Measures

Full Information

NCT ID

NCT03550027

First Posted

March 21, 2018

Last Updated

June 8, 2018

Sponsor

European Institute of Oncology

1. Study Identification

Unique Protocol Identification Number

NCT03550027

Brief Title

Indwelling Pleural Catheter for Trapped Lung

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

April 21, 2017 (Actual)

Primary Completion Date

November 3, 2017 (Actual)

Study Completion Date

February 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

European Institute of Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pleura; Effusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PleurX

Arm Type

Experimental

Arm Description

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

Arm Title

Pleurocath

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

PleurX

Intervention Description

Positioning of drainage PleurX

Intervention Type

Device

Intervention Name(s)

Pleurocath

Intervention Description

Positioning of drainage Pleurocath

Primary Outcome Measure Information:

Title

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

Description

Thoracic pain

Time Frame

Post operative day 4th

Title

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

Description

Dyspnea

Time Frame

Post operative day 4th

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francesco Petrella, MD, PhD

Organizational Affiliation

European Institute of Oncology

Official's Role

Principal Investigator

Facility Information:

Facility Name

European Institute of Oncology

City

Milan

ZIP/Postal Code

20141

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Indwelling Pleural Catheter for Trapped Lung

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