Parotid TumorsNCT07185542
Function-Preserving Surgery for Parotid Tumors: Intracapsular Versus Superficial Parotidectomy; A Randomized Clinical Trial.
A study testing Superficial parotidectomy and Intracapsular parotidectomy (ICP) in people with Parotid Tumors and Parotidectomy, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Benign parotid gland tumors, such as pleomorphic adenoma and Warthin tumors, constitute the majority of salivary gland neoplasms. Surgical excision remains the primary treatment, traditionally achieved through superficial parotidectomy (SP). Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Parotid Tumors, Parotidectomy
- What is being tested?
- Superficial parotidectomy and Intracapsular parotidectomy (ICP)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 5 May 2025
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 20 and 65 years,
- radiologically and clinically confirmed benign parotid tumor
- tumor confined to the superficial or deep lobe without evidence of facial nerve involvement.
Who cannot join
- suspicion of malignancy based on imaging or fine-needle aspiration cytology (FNAC)
- recurrent parotid tumors
- previous parotid surgery
- facial nerve dysfunction preoperatively
- comorbidities precluding surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Benign parotid gland tumors, such as pleomorphic adenoma and Warthin tumors, constitute the majority of salivary gland neoplasms. Surgical excision remains the primary treatment, traditionally achieved through superficial parotidectomy (SP). However, SP may lead to complications such as facial nerve dysfunction, Frey's syndrome, and aesthetic concerns. Intracapsular parotidectomy (ICP), a minimally invasive alternative, aims to minimize surgical morbidity while preserving oncologic safety. This study aimes to compare intracapsular parotidectomy and superficial parotidectomy in terms of operative efficiency, complications, facial nerve preservation, and tumor recurrence for benign parotid tumors.
- Conditions
- Parotid Tumors, Parotidectomy
- Being tested
- Superficial parotidectomy, Intracapsular parotidectomy (ICP)
- Medical subject headings
- Parotid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superficial parotidectomyProcedure or surgery
Superficial parotidectomy (SP), the traditional approach, involves facial nerve dissection and removal of the superficial lobe. Though effective, it carries risks like nerve dysfunction, Frey's syndrome, and cosmetic concerns
Intracapsular parotidectomy (ICP)Procedure or surgery
ICP excises the tumor along its capsule without dissecting the facial nerve, thereby minimizing trauma and preserving glandular tissue.
ICP is recommended for small, mobile, and superficially located benign tumors with low suspicion of malignancy. However, concerns remain regarding capsular rupture and recurrence, particularly in pleomorphic adenomas with microscopic extensions
| Study group | Role | What they receive |
|---|---|---|
| Intracapsular parotidectomy | Active comparator | ICP is recommended for small, mobile, and superficially located benign tumors with low suspicion of malignancy. However, concerns remain regarding capsular rupture and recurrence, particularly in pleomorphic adenomas with microscopic extensions Receives: Procedure: Intracapsular parotidectomy (ICP) |
| Superficial parotidectomy | Active comparator | Superficial parotidectomy (SP), the traditional approach, involves facial nerve dissection and removal of the superficial lobe. Though effective, it carries risks like nerve dysfunction, Frey's syndrome, and cosmetic concerns Receives: Procedure: Superficial parotidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Measured: Intraoperatively
Blood Loss
Measuring the amount of blood loss introperatively
Measured: Introperative
recurrence rate
Measured: 6 months postopeartively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 May 2024
- Primary completion1 May 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parotid TumorsStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Abd El Bary, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185542
- Sponsor's protocol ID
- Parotid Tumors Surgery
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Function-Preserving Surgery for Parotid Tumors: Intracapsular Versus Superficial Parotidectomy; A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07185542
- Acronym / sponsor ID
- Parotid Tumors Surgery
- Conditions
- Parotid Tumors, Parotidectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 22 Sep 2025 (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.
Benign parotid gland tumors, such as pleomorphic adenoma and Warthin tumors, constitute the majority of salivary gland neoplasms. Surgical excision remains the primary treatment, traditionally achieved through superficial parotidectomy (SP). However, SP may lead to complications such as facial nerve dysfunction, Frey's syndrome, and aesthetic concerns. Intracapsular parotidectomy (ICP), a minimally invasive alternative, aims to minimize surgical morbidity while preserving oncologic safety. This study aimes to compare intracapsular parotidectomy and superficial parotidectomy in terms of operative efficiency, complications, facial nerve preservation, and tumor recurrence for benign parotid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracapsular parotidectomy | Active comparator | Procedure: Intracapsular parotidectomy (ICP)ICP is recommended for small, mobile, and superficially located benign tumors with low suspicion of malignancy. However, concerns remain regarding capsular rupture and recurrence, particularly in pleomorphic adenomas with microscopic extensions |
| Superficial parotidectomy | Active comparator | Procedure: Superficial parotidectomySuperficial parotidectomy (SP), the traditional approach, involves facial nerve dissection and removal of the superficial lobe. Though effective, it carries risks like nerve dysfunction, Frey's syndrome, and cosmetic concerns |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 20 and 65 years,
- radiologically and clinically confirmed benign parotid tumor
- tumor confined to the superficial or deep lobe without evidence of facial nerve involvement.
Key exclusion criteria (5 listed)
- suspicion of malignancy based on imaging or fine-needle aspiration cytology (FNAC)
- recurrent parotid tumors
- previous parotid surgery
- facial nerve dysfunction preoperatively
- comorbidities precluding surgery.
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 |
|---|---|---|
| Superficial parotidectomySuperficial parotidectomy (SP), the traditional approach, involves facial nerve dissection and removal of the superficial lobe. Though effective, it carries risks like nerve dysfunction, Frey's syndrome, and cosmetic concerns | Procedure or surgery | Superficial parotidectomy |
| Intracapsular parotidectomy (ICP)ICP excises the tumor along its capsule without dissecting the facial nerve, thereby minimizing trauma and preserving glandular tissue. ICP is recommended for small, mobile, and superficially located benign tumors with low suspicion of malignancy. However, concerns remain regarding capsular rupture and recurrence, particularly in pleomorphic adenomas with microscopic extensions | Procedure or surgery | Intracapsular parotidectomy |
Primary outcome
Operative time
Time frame: Intraoperatively
Blood Loss
Time frame: Introperative
Measuring the amount of blood loss introperatively
recurrence rate
Time frame: 6 months postopeartively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superficial parotidectomy and Intracapsular parotidectomy (ICP) in people with Parotid Tumors and Parotidectomy, run by Al-Azhar 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 22 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: Intraoperatively). The study lists 3 primary outcomes in all. 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 22 Sep 2025.