Malignant Pleural Effusion: Pleur-X vs. Chemical Pleurode... | NCT03518788

Studies
Malignant Pleural Effusion: Pleur-X vs. Chemical Pleurodesis in VATS

NCT03518788

Sponsor

Rolf Inderbitzi

Status

Unknown status

Last Update Posted

May 8, 2018Actual

Enrollment

234Estimated

Phase

Not Applicable

Conditions

Malignant Pleural Effusion

Interventions

Pleur-X
Pleurodesis

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 25, 2018Actual

Primary Completion Date

Mar 31, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Apr 6, 2018

First Submission Date that Met QC Criteria

Apr 25, 2018

First Posted Date

May 8, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2018

Last Update Posted Date

May 8, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rolf Inderbitzi, Head of thoracic surgery department, Ente Ospedaliero Cantonale, BellinzonaSponsor-Investigator

Lead Sponsor

Rolf InderbitziOTHER

Collaborators

Name	Class
Clinical Trial Unit Ente Ospedaliero Cantonale	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a prospective randomized study whose aim is to compare the efficacy of the permanent thoracic catheter (Pleur-X) versus chemical pleurodesis in videothoracoscopy (VATS) in the treatment of malignant pleural effusion at the first diagnosis.Patients with malignant pleural effusion for whom there is indication of surgery and who agree to participate in the study will be randomized 1: 1 in the Pleur-X arm (arm 1) or in the chemical pleurodesis arm (arm 2).

The arm 1 provides for the installation of a permanent drainage under local anesthesia while the arm 2 provides a pleurodesis with talc in VATS under general anesthesia.

Both procedures are standard of care.

Detailed Description

Before the study procedure the patients will be requested to perform some examination as physical and radiological examination. Patients will also complete questionnaires for quality of life assessment (EORTC QLQ 30) and symptoms (VAS for pain). Patients will then be randomized into one of the two arms.

For patients included in arm 1, a permanent drainage (Pleur-X) is provided under local anesthesia performed on an outpatient basis while for patients included in arm 2 a pleurodesis with talc in VATS is planned under general anesthesia. Arm 2 patients will be hospitalized for 5 days.

Patients will then be followed up to 3 months after surgery. During this period a medical examination will be required at 1 week, 4 weeks and 3 months after the intervention during which the patient will be asked to complete questionnaires for the evaluation of quality of life (EORTC QLQ 30) and symptoms (VAS for pain ). A chest radiograph will be performed after four weeks to evaluate the primary parameter. Adverse events will be collected throughout the study period.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

234Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pleur-X	Experimental	Placement of a permanent drainage under local anesthesia	Procedure: Pleur-X
pleurodesis	Experimental	Pleurodesis with talc in VATS	Procedure: Pleurodesis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pleur-X	Procedure	Permanent drainage	Pleur-X
Pleurodesis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success rate of the treatment with VPM	Evaluate the success rate of the treatment with VPM with radiological examination	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Adverse Event	Evaluate the tollerability of both procedures collecting adverse events	3 months
Quality of live	quality of live will be determined with the evaluation of the EORTC QLQ 30 questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years, <80 years
First diagnosis of malignant pleural effusion
Indication to treat the malignant pleural effusion with surgery
Informed informed consent

Exclusion Criteria:

Previous surgeries on the same hemitorace
Pregnant women
Trapped lung syndrome
Patients with estimated life expectancy < 4-8 weeks

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rolf Inderbitzi, MD	Contact	+41 (0)91 811 91 76		rolf.inderbitzi@eoc.ch
Stefano Cafarotti, MD	Contact	+41 (0)91 811 93 40		stefano.cafarotti@eoc.ch

Overall Officials

Name	Affiliation	Role
Rolf Inderbitzi, MD	Ente Ospedaliero Cantonale, Bellinzona	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale San Giovanni	Recruiting	Bellinzona		6500	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D016066	Pleural Effusion, Malignant

Ancestor Terms

ID	Term
D010997	Pleural Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018700	Pleurodesis

Ancestor Terms

ID	Term
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided