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Thoracic Ultrasound in the Treatment of Pleural Effusion (ECHOPLEV)

Primary Purpose

Pleural Effusion

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Strategy with thoracic ultrasound
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Effusion

Eligibility Criteria

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

Inclusion Criteria:

  • Patients hospitalized or seen in consultation with pleural effusion diagnosed clinically or radiologically whatever be its initial management.

Exclusion Criteria:

  • Patient with a neoplasia

Sites / Locations

  • NOEL-SAVINA EliseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Strategy with thoracic ultrasound

Strategy without thoracic ultrasound

Arm Description

Use of thoracic ultrasound for the treatment of pleural effusion, treatment and monitoring. Use of other examinations like chest CT if necessary

Usual care : without thoracic ultrasound Use of chest radiography or chest CT scan if necessary, as for treatment and monitoring. Usual care: without the use of ultrasound Using either chest radiography or TDM if necessary, as for treatment and monitoring.

Outcomes

Primary Outcome Measures

The cost-effectiveness ration
Cost estimates will be conducted from the perspective of health insurance. The expenses incurred in the care of patients with pleurisy will be counted in both groups during the follow-up year. The effectiveness will be assessed against the complications of strategy (pneumothorax, respiratory sequelae, surgery, mortality, chest pain sequelae, radiological consequences).

Secondary Outcome Measures

The duration of hospitalization
number of day of hospitalization between the two strategies

Full Information

First Posted
July 21, 2015
Last Updated
November 6, 2020
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02505763
Brief Title
Thoracic Ultrasound in the Treatment of Pleural Effusion
Acronym
ECHOPLEV
Official Title
Treatment of Pleural Effusion by Routine Thoracic Ultrasound
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main objective of the study is to assess the cost-effectiveness ratio of two management strategies of pleurisy in adults : a strategy by systematic thoracic ultrasound versus a strategy without thoracic ultrasound.
Detailed Description
Comparison of two management strategies pleural effusions from diagnosis and during the first year of follow up care. Patients are randomized into two groups, each group receiving a different management strategy. Both strategies are compared: Strategy A that involves the systematic use of thoracic ultrasound for the treatment of pleural effusion, treatment and follow up care. It will be possible to have recourse to other tests (such as chest CT) if deemed necessary by the practitioner. Strategy B, which consists of the usual care pleurisy and thus without use of ultrasound: gestures are guided either by chest radiograph or by CT chest as necessary in the treatment and monitoring. A systematic radiographic pleural after each gesture is performed. The management is inspired by the English recommendations currently validated and applied in Anglo-Saxon countries.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Strategy with thoracic ultrasound
Arm Type
Experimental
Arm Description
Use of thoracic ultrasound for the treatment of pleural effusion, treatment and monitoring. Use of other examinations like chest CT if necessary
Arm Title
Strategy without thoracic ultrasound
Arm Type
No Intervention
Arm Description
Usual care : without thoracic ultrasound Use of chest radiography or chest CT scan if necessary, as for treatment and monitoring. Usual care: without the use of ultrasound Using either chest radiography or TDM if necessary, as for treatment and monitoring.
Intervention Type
Procedure
Intervention Name(s)
Strategy with thoracic ultrasound
Intervention Description
This strategy involves the systematic use of thoracic ultrasound for the treatment of pleural effusion, treatment and follow up care.
Primary Outcome Measure Information:
Title
The cost-effectiveness ration
Description
Cost estimates will be conducted from the perspective of health insurance. The expenses incurred in the care of patients with pleurisy will be counted in both groups during the follow-up year. The effectiveness will be assessed against the complications of strategy (pneumothorax, respiratory sequelae, surgery, mortality, chest pain sequelae, radiological consequences).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The duration of hospitalization
Description
number of day of hospitalization between the two strategies
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
The irradiation rate
Description
calculation of irradiation rate between the two strategies
Time Frame
1 year
Title
Number of consultations
Description
The number of consultations between the two strategies
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients hospitalized or seen in consultation with pleural effusion diagnosed clinically or radiologically whatever be its initial management. Exclusion Criteria: Patient with a neoplasia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elise NOEL-SAVINA, MD
Phone
0567771691
Ext
+33
Email
noel-savina.e@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Alain DIDIER, Professor
Phone
0567771830
Ext
+33
Email
didier.a@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elise NOEL-SAVINA, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
NOEL-SAVINA Elise
City
Toulouse
State/Province
Midi Pyrenees
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise NOEL-SAVINA, MD
Phone
0567771691
Ext
+33
Email
noel-savina.e@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Alain DIDIER, MD
Phone
0567771830
Ext
+33
Email
didier.a@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Elise NOEL-SAVINA, MD
First Name & Middle Initial & Last Name & Degree
Alain DIDIER, MD
First Name & Middle Initial & Last Name & Degree
Gavin PLAT, MD
First Name & Middle Initial & Last Name & Degree
Sandrine PONTIER-MARCHANDISE, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
20696688
Citation
Havelock T, Teoh R, Laws D, Gleeson F; BTS Pleural Disease Guideline Group. Pleural procedures and thoracic ultrasound: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii61-76. doi: 10.1136/thx.2010.137026. No abstract available.
Results Reference
background
PubMed Identifier
22700780
Citation
Reissig A, Copetti R, Mathis G, Mempel C, Schuler A, Zechner P, Aliberti S, Neumann R, Kroegel C, Hoyer H. Lung ultrasound in the diagnosis and follow-up of community-acquired pneumonia: a prospective, multicenter, diagnostic accuracy study. Chest. 2012 Oct;142(4):965-972. doi: 10.1378/chest.12-0364.
Results Reference
background
PubMed Identifier
12576360
Citation
Jones PW, Moyers JP, Rogers JT, Rodriguez RM, Lee YC, Light RW. Ultrasound-guided thoracentesis: is it a safer method? Chest. 2003 Feb;123(2):418-23. doi: 10.1378/chest.123.2.418.
Results Reference
background
PubMed Identifier
2110724
Citation
Ikezoe J, Morimoto S, Arisawa J, Takashima S, Kozuka T, Nakahara K. Percutaneous biopsy of thoracic lesions: value of sonography for needle guidance. AJR Am J Roentgenol. 1990 Jun;154(6):1181-5. doi: 10.2214/ajr.154.6.2110724.
Results Reference
background
PubMed Identifier
19255298
Citation
Chen HJ, Yu YH, Tu CY, Chen CH, Hsia TC, Tsai KD, Shih CM, Hsu WH. Ultrasound in peripheral pulmonary air-fluid lesions. Color Doppler imaging as an aid in differentiating empyema and abscess. Chest. 2009 Jun;135(6):1426-1432. doi: 10.1378/chest.08-2188. Epub 2009 Mar 2.
Results Reference
background

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Thoracic Ultrasound in the Treatment of Pleural Effusion

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