Role of Ultrasound Elastography in Pleural Effusion

Diagnostic performance of u.s elastography in pleural effusion

Study Overview

• Status: Not yet recruiting
• Conditions: Pleural Effusion
• Intervention / Treatment: Device: ultrasound Elastography

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mai Assem Abd-elkareem, resisdent doctor; Phone Number: +201000970497; Email: maiassem620@yahoo.com
• Study Contact Backup: Name: Suzan Salama sayed, professor; Phone Number: +201014236163

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 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: transudate effusion	Device: ultrasound Elastography; application of shear wave force by ultrasound elastography
Active Comparator: exudative effusion	Device: ultrasound Elastography; application of shear wave force by ultrasound elastography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: doaa mohamed magdy, associate prof, Assuit University Hospital; Study Director: sahar refaat mahmoud, lecturer, Assuit University Hospital

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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 13, 2022
• Primary Completion (Anticipated): August 13, 2025
• Study Completion (Anticipated): August 1, 2026

Study Registration Dates

• First Submitted: July 30, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Estimate): December 8, 2022

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: Ultrasound Elastography

Drug and device information, study documents

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