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Role of B Mode and Color Doppler Sonography in Differentiation Between Pleural Neoplasm and Inflammatory Pleural Thickening in Correlation With CT Findings

Primary Purpose

Pleural Thickening

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

biopsy under sonographic gidance

About this trial

This is an interventional diagnostic trial for Pleural Thickening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients diagnosed as having pleural thickening with or without pleural effusion. Exclusion Criteria: Emphysema or contraindication to pleural biopsy

Sites / Locations

Sohag University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pleural disease

Arm Description

Outcomes

Primary Outcome Measures

sensitivity of sonography in pleural thickening in comparison to CT and histopathology

sensitivity of sonography in cases of pleural thickening in comparison to CT findings and histopathology

Secondary Outcome Measures

Full Information

NCT ID

NCT05701462

First Posted

January 18, 2023

Last Updated

January 26, 2023

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT05701462

Brief Title

Role of B Mode and Color Doppler Sonography in Differentiation Between Pleural Neoplasm and Inflammatory Pleural Thickening in Correlation With CT Findings

Official Title

Role of B Mode and Color Doppler Sonography in Differentiation Between Pleural Neoplasm and Inflammatory Pleural Thickening in Correlation With CT Findings

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2023 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

pleura is a serous membrane, it consist of parietal pleura and visceral pleura. pleural thickening is any form of thickening involving the pleura more than 3 mm. there is malignant thickening : methoselioma, metastasis and non malignant thickening. trans thoracic USn is a reliable , safe and gold standard for studying pleura.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pleural Thickening

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

pleural disease

Arm Type

Experimental

Intervention Type

Diagnostic Test

Intervention Name(s)

biopsy under sonographic gidance

Intervention Description

pleural biopsy under sonographic guidance

Primary Outcome Measure Information:

Title

sensitivity of sonography in pleural thickening in comparison to CT and histopathology

Description

sensitivity of sonography in cases of pleural thickening in comparison to CT findings and histopathology

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult patients diagnosed as having pleural thickening with or without pleural effusion. Exclusion Criteria: Emphysema or contraindication to pleural biopsy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Asmaa H Mohammoed, resident

Phone

01008803318

asmaa011047@med.sohag.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Mohammed T Solyman, professor

Facility Information:

Facility Name

Sohag University Hospital

City

Sohag

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

magdy m amin, professor

12. IPD Sharing Statement

Citations:

PubMed Identifier

27282205

Citation

Porcel JM. Pleural ultrasound for clinicians. Rev Clin Esp (Barc). 2016 Nov;216(8):427-435. doi: 10.1016/j.rce.2016.05.009. Epub 2016 Jun 6. English, Spanish.

Results Reference

background

PubMed Identifier

25077699

Citation

Hallifax RJ, Haris M, Corcoran JP, Leyakathalikhan S, Brown E, Srikantharaja D, Manuel A, Gleeson FV, Munavvar M, Rahman NM. Role of CT in assessing pleural malignancy prior to thoracoscopy. Thorax. 2015 Feb;70(2):192-3. doi: 10.1136/thoraxjnl-2014-206054. Epub 2014 Jul 30.

Results Reference

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PubMed Identifier

24604935

Citation

Sureka B, Thukral BB, Mittal MK, Mittal A, Sinha M. Radiological review of pleural tumors. Indian J Radiol Imaging. 2013 Oct;23(4):313-20. doi: 10.4103/0971-3026.125577.

Results Reference

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PubMed Identifier

23355760

Citation

Pairon JC, Laurent F, Rinaldo M, Clin B, Andujar P, Ameille J, Brochard P, Chammings S, Ferretti G, Galateau-Salle F, Gislard A, Letourneux M, Luc A, Schorle E, Paris C. Pleural plaques and the risk of pleural mesothelioma. J Natl Cancer Inst. 2013 Feb 20;105(4):293-301. doi: 10.1093/jnci/djs513. Epub 2013 Jan 25.

Results Reference

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Role of B Mode and Color Doppler Sonography in Differentiation Between Pleural Neoplasm and Inflammatory Pleural Thickening in Correlation With CT Findings

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