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Elastography in the Evaluation of Major Salivary Gland Lesions

NCT ID: NCT05151029

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Salivary Gland Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Elastography

new dignostic tool

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ramy Refaat Ayoub Eshak

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samy abdelaziz

Role: PRINCIPAL_INVESTIGATOR

professor of dignostic radiology

Central Contacts

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Ramy refaat, master

Role: CONTACT

Phone: 01008608677

Email: [email protected]

Noha Attya

Role: CONTACT

Phone: 01065742341

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 22021543 (View on PubMed)

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. doi: 10.7863/ultra.15.11093. Epub 2016 Oct 25.

Reference Type BACKGROUND
PMID: 27872416 (View on PubMed)

Karaman CZ, Basak S, Polat YD, Unsal A, Taskin F, Kaya E, Gunel 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.

Reference Type BACKGROUND
PMID: 30426518 (View on PubMed)

Other Identifiers

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Major salivary gland lesions

Identifier Type: -

Identifier Source: org_study_id