NCT05642091

Brief Summary

Diagnostic performance of u.s elastography in pleural effusion

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Dec 2022

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Dec 2022Aug 2026

First Submitted

Initial submission to the registry

July 30, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

December 13, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

2.7 years

First QC Date

July 30, 2022

Last Update Submit

December 6, 2022

Conditions

Pleural Effusion

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

transudate effusion

ACTIVE COMPARATOR
Device: ultrasound Elastography

exudative effusion

ACTIVE COMPARATOR
Device: ultrasound Elastography

Interventions

ultrasound ElastographyDEVICE

application of shear wave force by ultrasound elastography

exudative effusiontransudate effusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with pleural effusion above18 year

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 20696692BACKGROUND

  • 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.

    PMID: 31151959BACKGROUND

  • 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.

    PMID: 12728147BACKGROUND

  • 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.

    PMID: 4642731BACKGROUND

  • 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.

    PMID: 30054348BACKGROUND

  • 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.

    PMID: 20696688BACKGROUND

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • doaa mohamed magdy, associate prof

    assuit university hospital

    STUDY DIRECTOR

  • sahar refaat mahmoud, lecturer

    assuit university hospital

    STUDY DIRECTOR

Central Study Contacts

Mai Assem Abd-elkareem, resisdent doctor

CONTACT

+201000970497maiassem620@yahoo.com

Suzan Salama sayed, professor

CONTACT

+201014236163

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 30, 2022

First Posted

December 8, 2022

Study Start

December 13, 2022

Primary Completion

August 13, 2025

Study Completion (Estimated)

August 1, 2026

Last Updated

December 8, 2022

Record last verified: 2022-12