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Role of US,Doppler in Major Salivary Gland Diseases

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ClinicalTrials.gov Identifier: NCT03746730
Recruitment Status : Not yet recruiting
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
galal mohamed galal, Assiut University

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

Condition or disease Intervention/treatment
Salivary Gland Diseases Device: ultrasound

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.


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ROLE OF Gray Scale and Doppler Ultrasound in Diagnosis of Parotid and Submandibular Gland Diseases
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: ultrasound
    gray scale and doppler ultrasound


Primary Outcome Measures :
  1. the role of gray scale and Doppler ultrasound in characterizing of parotid and submandibular gland diseases in comparison to biopsy if needed [ Time Frame: baseline ]
    the role of gray scale and Doppler ultrasound in characterizing of parotid and submandibular gland diseases in comparison to biopsy if needed



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746730


Contacts
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Contact: galal galal, bachelor +201064353435 galalmuhammed28@gmail.com
Contact: mostafa ahmed, phd +20882413280 mostafaharera@aun.edu.eg

Sponsors and Collaborators
Assiut University

Publications:
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Responsible Party: galal mohamed galal, Prinicible investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03746730     History of Changes
Other Study ID Numbers: US,Doppler salivary diseases
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Salivary Gland Diseases
Submandibular Gland Diseases
Mouth Diseases
Stomatognathic Diseases