Thoracic Ultrasound in the Treatment of Pleural Effusion (ECHOPLEV)

Treatment of Pleural Effusion by Routine Thoracic Ultrasound

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.

Study Overview

• Status: Unknown
• Conditions: Pleural Effusion
• Intervention / Treatment: Procedure: Strategy with 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.

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Midi Pyrenees
    • Toulouse, Midi Pyrenees, France, 31059
      • Recruiting
      • NOEL-SAVINA Elise
      • Contact: Elise NOEL-SAVINA, MD; Phone Number: +33 0567771691; Email: noel-savina.e@chu-toulouse.fr
      • Contact: Alain DIDIER, MD; Phone Number: +33 0567771830; Email: didier.a@chu-toulouse.fr
      • Principal Investigator: Elise Noel-Savina, MD
      • Sub-Investigator: Alain Didier, MD
      • Sub-Investigator: Gavin PLAT, MD
      • Sub-Investigator: Sandrine Pontier-Marchandise, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Strategy with thoracic ultrasound; Use of thoracic ultrasound for the treatment of pleural effusion, treatment and monitoring.; Use of other examinations like chest CT if necessary	Procedure: Strategy with thoracic ultrasound; This strategy involves the systematic use of thoracic ultrasound for the treatment of pleural effusion, treatment and follow up care.
No Intervention: Strategy without thoracic ultrasound; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The duration of hospitalization	number of day of hospitalization between the two strategies	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The irradiation rate	calculation of irradiation rate between the two strategies	1 year
Number of consultations	The number of consultations between the two strategies	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Elise Noel-Savina, MD, University Hospital, Toulouse

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2017
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 21, 2015
• First Submitted That Met QC Criteria: July 21, 2015
• First Posted (Estimate): July 22, 2015

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: RC31/14/7418

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No