Salivary Gland DiseasesNCT03746730
Role of US,Doppler in Major Salivary Gland Diseases
An observational study of Salivary Gland Diseases, run by Assiut University.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Salivary Gland Diseases
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2018to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- Patients in different age and sex groups with neck swelling, pain or any complaint related to major salivary gland detected by clinical examination.
Who cannot join
- patients who refused to sign a consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: ROLE OF Gray Scale and Doppler Ultrasound in Diagnosis of Parotid and Submandibular Gland Diseases
To evaluate the role of gray scale and Doppler ultrasound in characterizing of parotid and submandibular gland lesions in comparison to biopsy if needed
Read the 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.
- Conditions
- Salivary Gland Diseases
- Being tested
- ultrasound
- Medical subject headings
- Salivary Gland Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
gray scale and doppler ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start1 Dec 2018 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Salivary Gland DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, galal mohamed galal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746730
- Sponsor's protocol ID
- US,Doppler salivary diseases
- Status last verified
- Nov 2018
- First submitted
- 30 Sep 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29430614Rzepakowska 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.
PubMed 28612315
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROLE OF Gray Scale and Doppler Ultrasound in Diagnosis of Parotid and Submandibular Gland Diseases
- ClinicalTrials.gov ID
- NCT03746730
- Acronym / sponsor ID
- US,Doppler salivary diseases
- Conditions
- Salivary Gland Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients in different age and sex groups with neck swelling, pain or any complaint related to major salivary gland detected by clinical examination.
Key exclusion criteria (1 listed)
- patients who refused to sign a consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundgray scale and doppler ultrasound | Device | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Background: PubMed 29430614Zhang 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.
- Background: PubMed 28612315Rzepakowska 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Salivary Gland Diseases, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact galal galal, bachelor (+201064353435, galalmuhammed28@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03746730, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.