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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03746730
Other study ID # US,Doppler salivary diseases
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date October 1, 2020

Study information

Verified date November 2018
Source Assiut University
Contact galal galal, bachelor
Phone +201064353435
Email galalmuhammed28@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To evaluate the role of gray scale and Doppler ultrasound in characterizing of parotid and submandibular gland lesions in comparison to biopsy if needed


Description:

* Salivary glands are affected by variety of disease processes which include infective, inflammatory, systemic, obstructive and neoplastic conditions . Clinical examination alone will not provide the correct diagnosis of salivary gland pathologies. Thus, radiological evaluation is essential in correct diagnosis .

USG plays a significant and crucial role in the diagnosis and management of salivary gland lesions. Results of the USG examination alone may suggest the final diagnosis or provide important differential diagnostic data . USG can differentiate intraglandular from extraglandular lesions in 98% of cases. It can differentiate salivary gland lesions as focal or diffuse. Characterisation of focal lesions into benign and malignant can be done by evaluation of edges. With high resolution transducers USG is better than CT or MRI in detection of unsharp borders .

Color Doppler findings are helpful in characterising the pathologies. It is helpful in diagnosing pleomorphic adenoma. Doppler findings of intralesional vascularity, type and grade of vascularity, PSV, RI and PI are useful in differentiating benign from malignant tumours . Pathological diagnosis can be established by Fine Needle Aspiration Cytology (FNAC). FNAC is preferably done under USG guidance. This helps in further enhancing ability of USG to differentiate between benign and malignant lesions .

Other radiological investigations for evaluation of salivary gland pathologies are plain radiography, sialography, CT, MRI and PET-CT .

Sometimes it is not possible to visualize lesions completely on USG because of their location, extension into the deep lobe of the parotid gland or behind the acoustic shadow of the mandible In these situations, further imaging with CT or MRI is necessary.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date October 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients in different age and sex groups with neck swelling, pain or any complaint related to major salivary gland detected by clinical examination.

Exclusion Criteria:

- patients who refused to sign a consent

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ultrasound
gray scale and doppler ultrasound

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

Rzepakowska A, Osuch-Wójcikiewicz E, Sobol M, Cruz R, Sielska-Badurek E, Niemczyk K. The differential diagnosis of parotid gland tumors with high-resolution ultrasound in otolaryngological practice. Eur Arch Otorhinolaryngol. 2017 Aug;274(8):3231-3240. doi: 10.1007/s00405-017-4636-2. Epub 2017 Jun 13. — View Citation

Zhang W, Zuo Z, Luo N, Liu L, Jin G, Liu J, Su D. Non-enhanced MRI in combination with color Doppler flow imaging for improving diagnostic accuracy of parotid gland lesions. Eur Arch Otorhinolaryngol. 2018 Apr;275(4):987-995. doi: 10.1007/s00405-018-4895-6. Epub 2018 Feb 12. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary the role of gray scale and Doppler ultrasound in characterizing of parotid and submandibular gland diseases in comparison to biopsy if needed the role of gray scale and Doppler ultrasound in characterizing of parotid and submandibular gland diseases in comparison to biopsy if needed baseline
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