Role of Ultrasound Elastography in Pleural Effusion
Primary Purpose
Pleural Effusion
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ultrasound Elastography
Sponsored by
About this trial
This is an interventional diagnostic trial for Pleural Effusion
Eligibility Criteria
Inclusion Criteria: .patients with pleural effusion above18 year Exclusion Criteria: patients who refuse to undergone further investigations to reach final diagnosis of cause of pleural effusion .patients with intercostal tube inserted in the effusion before enrollment in the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
transudate effusion
exudative effusion
Arm Description
Outcomes
Primary Outcome Measures
detect diagnostic performance of ultrasound elastography in pleural effusion
differentiate between elastisty index in benign and malignant pleural effuison that expressed in kpa by measuring it using ultrasound elastography
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05642091
Brief Title
Role of Ultrasound Elastography in Pleural Effusion
Official Title
Role of Ultrasound Elastography in Pleural Effusion
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 13, 2022 (Anticipated)
Primary Completion Date
August 13, 2025 (Anticipated)
Study Completion Date
August 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Diagnostic performance of u.s elastography in pleural effusion
Detailed Description
Pleural fluid is an extremely common problem however the diagnosis of pleural effusion remain challenging due its diverse aetiologies .transthoracic ultrasound is often the initial tool to help diagnosis of pleural effusion.
Ultrasound elastography is a novel ultrasound technology that can differentiate malignant disease from benign disease by quantitatively assses tissue stifness by measuring the degree of distortion under application of an external force (shear wave ) However, very limited studies are available evaluating the efficacy of this novel technique in diagnosis of malignant pleural effusion.
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
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
transudate effusion
Arm Type
Active Comparator
Arm Title
exudative effusion
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
ultrasound Elastography
Intervention Description
application of shear wave force by ultrasound elastography
Primary Outcome Measure Information:
Title
detect diagnostic performance of ultrasound elastography in pleural effusion
Description
differentiate between elastisty index in benign and malignant pleural effuison that expressed in kpa by measuring it using ultrasound elastography
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
.patients with pleural effusion above18 year
Exclusion Criteria:
patients who refuse to undergone further investigations to reach final diagnosis of cause of pleural effusion
.patients with intercostal tube inserted in the effusion before enrollment in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mai Assem Abd-elkareem, resisdent doctor
Phone
+201000970497
Email
maiassem620@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Suzan Salama sayed, professor
Phone
+201014236163
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
doaa mohamed magdy, associate prof
Organizational Affiliation
assuit university hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
sahar refaat mahmoud, lecturer
Organizational Affiliation
assuit university hospital
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
20696692
Citation
Hooper C, Lee YC, Maskell N; BTS Pleural Guideline Group. Investigation of a unilateral pleural effusion in adults: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii4-17. doi: 10.1136/thx.2010.136978. No abstract available.
Results Reference
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PubMed Identifier
31151959
Citation
Jiang B, Li XL, Yin Y, Zhang Q, Zang T, Song WS, Wang XM, Kang J, Herth FJF, Hou G. Ultrasound elastography: a novel tool for the differential diagnosis of pleural effusion. Eur Respir J. 2019 Aug 22;54(2):1802018. doi: 10.1183/13993003.02018-2018. Print 2019 Aug.
Results Reference
background
PubMed Identifier
12728147
Citation
Davies CW, Gleeson FV, Davies RJ; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the management of pleural infection. Thorax. 2003 May;58 Suppl 2(Suppl 2):ii18-28. doi: 10.1136/thorax.58.suppl_2.ii18. No abstract available.
Results Reference
background
PubMed Identifier
4642731
Citation
Light RW, Macgregor MI, Luchsinger PC, Ball WC Jr. Pleural effusions: the diagnostic separation of transudates and exudates. Ann Intern Med. 1972 Oct;77(4):507-13. doi: 10.7326/0003-4819-77-4-507. No abstract available.
Results Reference
background
PubMed Identifier
30054348
Citation
Bibby AC, Dorn P, Psallidas I, Porcel JM, Janssen J, Froudarakis M, Subotic D, Astoul P, Licht P, Schmid R, Scherpereel A, Rahman NM, Cardillo G, Maskell NA. ERS/EACTS statement on the management of malignant pleural effusions. Eur Respir J. 2018 Jul 27;52(1):1800349. doi: 10.1183/13993003.00349-2018. Print 2018 Jul.
Results Reference
background
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
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Role of Ultrasound Elastography in Pleural Effusion
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