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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05151029
Other study ID # Major salivary gland lesions
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date October 1, 2023

Study information

Verified date November 2021
Source Assiut University
Contact Ramy refaat, master
Phone 01008608677
Email ramyrefaatayoub@outlook.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

2.2 Aim(s) of the Research (50 words max): To investigate the diagnostic accuracy of Sonoelastography in the evaluation of major salivary gland lesions using histopathology as gold standard.


Description:

Salivary gland diseases are ranging from the minor inflammatory conditions to a group of benign and malignant neoplasms. Most of the salivary gland disorders manifest themselves as the enlargement of the gland which may be associated with pain or swelling. Physical examination together with laboratory analyses may not be sufficient to discriminate these diseases . Therefore, an accurate, non invasive diagnostic method is needed to discriminate these diseases (1). Although ultrasound-guided fine-needle aspiration cytology (FNAC) is considered the gold standard for preoperative diagnosis (2), it is an invasive method requiring significant experience to avoid complications like injury of the facial nerve as it courses within the parotid gland. This explains the continuing desire for further non-invasive diagnostic options (3). The current imaging modalities are ultrasonography, Computed Tomography (CT) and Magnetic Resonance Imaging (MRI). Despite being highly sensitive, they lack the accuracy in differentiating benign and malignant lesions because of considerable overlap between the imaging features of benign and malignant salivary gland lesions. Sonoelastography is a new technique that depends on the elastic properties of soft tissues, with the idea of malignant lesions being stiffer than benign or normal tissue. It may have a dependable role in diagnosing different salivary gland diseases, the same way it has been used in different parts of the body, such as the breast, lymph nodes, and thyroid (4). To the best of our knowledge, there are few studies concerning the role of elastography in the field of salivary gland disease.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 34
Est. completion date October 1, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria - All patients with clinically suspected lesions of parotid or submandibular glands . - An equal number of healthy volunteers will be included during the same period as control group . Exclusion Criteria: • A mass with ulcerated or raw surface, involvement of the whole gland by the lesion or previous surgical treatment

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Elastography
new dignostic tool

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (3)

Dumitriu D, Dudea S, Botar-Jid C, Baciut M, Baciut G. Real-time sonoelastography of major salivary gland tumors. AJR Am J Roentgenol. 2011 Nov;197(5):W924-30. doi: 10.2214/AJR.11.6529. — View Citation

Karaman CZ, Basak S, Polat YD, Ünsal A, Taskin F, Kaya E, Günel C. The Role of Real-Time Elastography in the Differential Diagnosis of Salivary Gland Tumors. J Ultrasound Med. 2019 Jul;38(7):1677-1683. doi: 10.1002/jum.14851. Epub 2018 Nov 13. — View Citation

Zhou H, Zhou XL, Xu HX, He YP, Bo XW, Li XL, Liu BJ, Li DD, Wang D. Initial Experience With Ultrasound Elastography for Diagnosis of Major Salivary Gland Lesions. J Ultrasound Med. 2016 Dec;35(12):2597-2606. Epub 2016 Oct 25. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary the diagnostic accuracy of Sonoelastography in the evaluation of major salivary gland lesions 2-The discrimination between different salivary gland diseases by non invasive available technique as far as possible. To investigate the dia Use of elastography in major salivarygland lesions benign or malignant from october 2022 to october 2023
Primary -The discrimination between different salivary gland diseases by non invasive available technique . -The discrimination between different salivary gland diseases by non invasive available technique as far as possible. -The discri Differentiation between salivary gland lesions from october 2022 to october 2023
Secondary Elastography importance in salivary gland disease Differentiation of Salivary gland masses From October 2022 to October 2023
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