Thoracic Ultrasound in the Treatment of Pleural Effusion

NCT ID: NCT02505763

Last Updated: 2020-11-09

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-10

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Pleural 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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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

Group Type EXPERIMENTAL

Strategy with thoracic ultrasound

Intervention Type PROCEDURE

This strategy involves the systematic use of thoracic ultrasound for the treatment of pleural effusion, treatment and follow up care.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Strategy with thoracic ultrasound

This strategy involves the systematic use of thoracic ultrasound for the treatment of pleural effusion, treatment and follow up care.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elise NOEL-SAVINA, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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NOEL-SAVINA Elise

Toulouse, Midi Pyrenees, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Elise NOEL-SAVINA, MD

Role: CONTACT

Phone: 0567771691

Email: [email protected]

Alain DIDIER, Professor

Role: CONTACT

Phone: 0567771830

Email: [email protected]

Facility Contacts

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Elise NOEL-SAVINA, MD

Role: primary

Alain DIDIER, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 20696688 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22700780 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12576360 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2110724 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19255298 (View on PubMed)

Other Identifiers

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RC31/14/7418

Identifier Type: -

Identifier Source: org_study_id