Clinical trial NCT02505763: Thoracic Ultrasound in the Treatment of Pleural Effusion
Official title: Treatment of Pleural Effusion by Routine Thoracic Ultrasound
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pleural Effusion
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The cost-effectiveness ration
timeFrame: 1 year
Secondary outcomes:
measure: The duration of hospitalization
timeFrame: 1 year
Other outcomes:
measure: The irradiation rate
timeFrame: 1 year
measure: Number of consultations
timeFrame: 1 year
Locations:
city: Toulouse
country: France
facility: NOEL-SAVINA Elise
state: Midi Pyrenees
Study officials:
affiliation: University Hospital, Toulouse
name: Elise NOEL-SAVINA, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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