Role of Ultrasound Elastography in Pleural Effusion

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05642091
Collaborator
(none)
80
2
43.6

Study Details

Study Description

Brief Summary

Diagnostic performance of u.s elastography in pleural effusion

Condition or Disease Intervention/Treatment Phase
  • Device: ultrasound Elastography
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Role of Ultrasound Elastography in Pleural Effusion
Anticipated Study Start Date :
Dec 13, 2022
Anticipated Primary Completion Date :
Aug 13, 2025
Anticipated Study Completion Date :
Aug 1, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. detect diagnostic performance of ultrasound elastography in pleural effusion [3 months]

    differentiate between elastisty index in benign and malignant pleural effuison that expressed in kpa by measuring it using ultrasound elastography

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: doaa mohamed magdy, associate prof, assuit university hospital
  • Study Director: sahar refaat mahmoud, lecturer, assuit university hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mai Assem Abd-elkareem Aly, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05642091
Other Study ID Numbers:
  • Ultrasound Elastography
First Posted:
Dec 8, 2022
Last Update Posted:
Dec 8, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 8, 2022