Clinical trial NCT03746730: Role of US,Doppler in Major Salivary Gland Diseases
Official title: ROLE OF Gray Scale and Doppler Ultrasound in Diagnosis of Parotid and Submandibular Gland Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Salivary Gland Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in different age and sex groups with neck swelling, pain or any complaint related to parotid and submandibular gland detected by clinical examination.

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: the role of gray scale and Doppler ultrasound in characterizing of parotid and submandibular gland diseases in comparison to biopsy if needed
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.
citation: Rzepakowska A, Osuch-Wojcikiewicz 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.