Warthin's Tumor of Parotid GlandNCT05221736
Management of Warthin Tumor of Parotid Gland.
A study testing Ultrasound-Guided Ethanol Sclerotherapy (UGES) in people with Warthin's Tumor of Parotid Gland, run by Assiut University at 1 site in Egypt.
Trial summary
Comparison between Ultrasound-Guided Ethanol Sclerotherapy (UGES) \& surgical excision in management of warthin tumor of parotid gland. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Warthin's Tumor of Parotid Gland
- What is being tested?
- Ultrasound-Guided Ethanol Sclerotherapy (UGES)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 31 Oct 2023
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All new cases presented with benign parotid cyst and diagnosed as Warthin tumour in the parotid gland.
Who cannot join
- Other Parotid gland tumours e.g. solid tumours, malignant tumours and other suspicious tumours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Ultrasound-Guided Ethanol Sclerotherapy (UGES) & Surgical Excision in Management of Warthin Tumor of Parotid Gland.
Comparison between Ultrasound-Guided Ethanol Sclerotherapy (UGES) \& surgical excision in management of warthin tumor of parotid gland.
Read the detailed description
Warthin tumor (also known as cystadenolymphoma), is a benign and frequent salivary gland neoplasm.
It represents about 2% to 15% of all primary epithelial tumors of the parotid gland.
Warthin tumor is histologically characterized by a dense lymphoid stroma and a double layer of oncocytic epithelium with a papillary and cystic architectural pattern.
Its etiology: remains controversial. Incidence: It is the second most frequent benign neoplasm of the salivary glands after pleomorphic adenoma. Pathophysiology: Initially, Hildebrand proposed that the lesion may be remnants of the branchial pouches and a variant of the lateral cervical cyst. Later, Albrech and Artz proposed the heterotropic origin of Warthin tumor from the neoplastic proliferation of salivary gland ducts present within intra- or para-parotid nodes. Histopathology: Grossly, Warthin tumor is a well-circumscribed spherical to oval mass. On cut section, there are solid areas and multiple cysts with papillary projections.
Cytology: Smears characteristically show oncocytic epithelial cells without atypia admixed with polymorphous lymphocytes and cellular debris.
Microscopic Findings: Warthin tumors are composed of varying proportions of papillary- cystic structures lined by oncocytic epithelial cells and a lymphoid stroma with germinal centers.
Clinically, Warthin tumor presents as a rounded or an ovoid nodular painless, slow-growing, fluctuant to firm at palpation. It can be unilateral, bilateral, or multicentric and is asymptomatic in 90% of cases.
Prognosis: Warthin's tumor has a favorable prognosis and almost never recurs. Malignant degeneration of Warthin tumor is very rare.
Complications:
Local Recurrence; The local recurrence rate is low; when recurrence does occur, it is probably due to multifocal tumors or inadequate excision.
Malignant Transformation; Malignant transformation in a Warthin tumor is extremely rare. The most frequent histological types of malignant transformation in a Warthin tumor are mucoepidermoid carcinoma, squamous cell carcinoma, undifferentiated carcinoma, oncocytic adenocarcinoma, and adenocarcinoma.
- Conditions
- Warthin's Tumor of Parotid Gland
- Being tested
- Ultrasound-Guided Ethanol Sclerotherapy (UGES)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Ethanol Sclerotherapy (UGES)Procedure or surgery
Also called Surgical excision
Comparison between Ultrasound-Guided Ethanol Sclerotherapy (UGES) \& surgical excision in management of warthin tumor of parotid gland.
| Study group | Role | What they receive |
|---|---|---|
| Warthin tumor in parotid tumor | Experimental | Comparison between Ultrasound-Guided Ethanol Sclerotherapy (UGES) \& surgical excision in management of warthin tumor of parotid gland. Receives: Procedure: Ultrasound-Guided Ethanol Sclerotherapy (UGES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary (main):
Rate of curability in each group
Measured: 1 year
Secondary outcomes (1)
Secondary (subsidiary):
Rate of facial nerve injury in each group
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 May 2022 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Warthin's Tumor of Parotid GlandStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kerolos nashaat hosny, Assiut University
- Investigators
- Hamdan S. Abbas, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221736
- Sponsor's protocol ID
- Warthin tumor of parotid gland
- Status last verified
- Jan 2022
- First submitted
- 7 Jan 2022
- Last updated
- 3 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: age, sex , clinical diagnosis
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultrasound-Guided Ethanol Sclerotherapy (UGES) & Surgical Excision in Management of Warthin Tumor of Parotid Gland.
- ClinicalTrials.gov ID
- NCT05221736
- Acronym / sponsor ID
- Warthin tumor of parotid gland
- Conditions
- Warthin's Tumor of Parotid Gland
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 3 Feb 2022 (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.
Comparison between Ultrasound-Guided Ethanol Sclerotherapy (UGES) \& surgical excision in management of warthin tumor of parotid gland.
Detailed description
Warthin tumor (also known as cystadenolymphoma), is a benign and frequent salivary gland neoplasm.
It represents about 2% to 15% of all primary epithelial tumors of the parotid gland.
Warthin tumor is histologically characterized by a dense lymphoid stroma and a double layer of oncocytic epithelium with a papillary and cystic architectural pattern.
Its etiology: remains controversial. Incidence: It is the second most frequent benign neoplasm of the salivary glands after pleomorphic adenoma. Pathophysiology: Initially, Hildebrand proposed that the lesion may be remnants of the branchial pouches and a variant of the lateral cervical cyst. Later, Albrech and Artz proposed the heterotropic origin of Warthin tumor from the neoplastic proliferation of salivary gland ducts present within intra- or para-parotid nodes. Histopathology: Grossly, Warthin tumor is a well-circumscribed spherical to oval mass. On cut section, there are solid areas and multiple cysts with papillary projections.
Cytology: Smears characteristically show oncocytic epithelial cells without atypia admixed with polymorphous lymphocytes and cellular debris.
Microscopic Findings: Warthin tumors are composed of varying proportions of papillary- cystic structures lined by oncocytic epithelial cells and a lymphoid stroma with germinal centers.
Clinically, Warthin tumor presents as a rounded or an ovoid nodular painless, slow-growing, fluctuant to firm at palpation. It can be unilateral, bilateral, or multicentric and is asymptomatic in 90% of cases.
Prognosis: Warthin's tumor has a favorable prognosis and almost never recurs. Malignant degeneration of Warthin tumor is very rare.
Complications:
Local Recurrence; The local recurrence rate is low; when recurrence does occur, it is probably due to multifocal tumors or inadequate excision.
Malignant Transformation; Malignant transformation in a Warthin tumor is extremely rare. The most frequent histological types of malignant transformation in a Warthin tumor are mucoepidermoid carcinoma, squamous cell carcinoma, undifferentiated carcinoma, oncocytic adenocarcinoma, and adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Warthin tumor in parotid tumor | Experimental | Procedure: Ultrasound-Guided Ethanol Sclerotherapy (UGES)Comparison between Ultrasound-Guided Ethanol Sclerotherapy (UGES) \& surgical excision in management of warthin tumor of parotid gland. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All new cases presented with benign parotid cyst and diagnosed as Warthin tumour in the parotid gland.
Key exclusion criteria (1 listed)
- Other Parotid gland tumours e.g. solid tumours, malignant tumours and other suspicious tumours.
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 |
|---|---|---|
| Ultrasound-Guided Ethanol Sclerotherapy (UGES)Also: Surgical excisionComparison between Ultrasound-Guided Ethanol Sclerotherapy (UGES) \& surgical excision in management of warthin tumor of parotid gland. | Procedure or surgery | Warthin tumor in parotid tumor |
Primary outcome
Primary (main):
Time frame: 1 year
Rate of curability in each group
1 secondary outcome
Secondary (subsidiary):
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Individual participant dataSharing planned: Yes. age, sex , clinical diagnosis
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.
Hamdan S. Abbas study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Ethanol Sclerotherapy (UGES) in people with Warthin's Tumor of Parotid Gland, run by Assiut University at 1 site in Egypt.
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 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Kerolos N. Hosny (+201033216963, kerolosnashaat93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary (main): (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2022.