Benign Tumor of Parotid GlandNCT07028437
The Effect of Endoscopy-assisted Transoral Parotid Gland Tumor Excision Compared With Traditional Operation
A study testing Endoscopic-assisted transoral approach for parotid tumor resection and Blair S-shaped incision for parotid tumor in people with Benign Tumor of Parotid Gland and Endoscope-assisted Surgery, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Endoscopic-assisted surgery has become a popular technique in salivary gland surgery, particularly for parotid gland tumors. However, this technique has not yet been routinely applied to transoral parotid tumor resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Benign Tumor of Parotid Gland, Endoscope-assisted Surgery, Gland Preservation
- What is being tested?
- Endoscopic-assisted transoral approach for parotid tumor resection and Blair S-shaped incision for parotid tumor
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Mar 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary benign parotid tumors all underwent CT, MRI and ultrasound-guided FNAC examinations of parotid tumors before the operation. All the patients underwent glandular preservation surgery.
Who cannot join
- The tumor diameter is greater than 6cm, has undergone radiotherapy, is a highly malignant tumor, a tumor invading the skin, and a recurrent tumor.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
About this study
Endoscopic-assisted surgery has become a popular technique in salivary gland surgery, particularly for parotid gland tumors. However, this technique has not yet been routinely applied to transoral parotid tumor resection. This retrospective study aimed to evaluate the outcomes of gland-preserving surgery in patients with benign parotid tumors undergoing endoscopic-assisted transoral resection.
The study included 30 patients with benign parotid tumors who underwent gland-preserving tumor resection: 15 underwent endoscopic-assisted transoral resection, while the other 15 underwent conventional tumor resection via the Blair S-shaped incision. Surgical feasibility, perioperative variables, postoperative appearance, and functional outcomes were assessed.
Read more
In both groups, all tumors were completely removed with negative margins. No significant differences were observed between the two groups in terms of intraoperative blood loss, postoperative drainage volume, average incision length, or facial nerve injury. However, the endoscopic-assisted transoral group demonstrated superior cosmetic outcomes. No tumor recurrence was observed during the 1-6 month follow-up period.
Therefore, endoscopic-assisted transoral parotid tumor resection is a safe approach for benign parotid tumors, offering both favorable functional and aesthetic results.
Read the detailed description
The incidence of parotid gland tumors is approximately 1 in 100,000, accounting for 80% of all salivary gland tumors, with about 80% being benign. Parotid tumor resection is a well-established surgical technique. Traditionally, the Blair S-shaped incision has been used, but it leaves noticeable scars on the maxillofacial region, which can be a significant burden for both surgeons and patients. Additionally, postoperative complications such as great auricular nerve injury may occur.
In the mid-20th century, the standard surgical approaches for benign parotid tumors included total parotidectomy (with facial nerve sacrifice) or superficial parotidectomy (preserving the facial nerve), which significantly reduced tumor recurrence rates. However, due to the extensive surgical scope, these procedures were associated with a high incidence of complications such as facial nerve dysfunction, Frey's syndrome, salivary fistula, and facial scar deformities.
In recent years, with growing interest in minimally invasive surgery, studies have found that subtotal parotidectomy for benign parotid tumors not only reduces postoperative complications but also maintains comparable recurrence rates. To meet patients' aesthetic demands, more concealed hairline incisions have gained popularity, as the scars can be hidden behind the ear.
With advancements in minimally invasive techniques for parotid tumor surgery, surgeons have developed various approaches to minimize scarring and reduce complications, including retroauricular sulcus incisions, endoscopic-assisted techniques, and transoral/intraoral resections. Endoscopic-assisted techniques leave minimal or hidden scars postoperatively. The combination of intraoral incisions and endoscopy can further conceal surgical scars, reduce patient trauma, and improve satisfaction-without significant complications compared to traditional transcutaneous approaches.
- Conditions
- Benign Tumor of Parotid Gland, Endoscope-assisted Surgery, Gland Preservation, Minimally Invasive Surgery
- Being tested
- Endoscopic-assisted transoral approach for parotid tumor resection, Blair S-shaped incision for parotid tumor
- Keywords
- transoral parotid gland tumor excision, Endoscope-assisted, minimally invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic-assisted transoral approach for parotid tumor resectionProcedure or surgery
The buccal mucosa was incised in front of the mandibular ligament of the inner wing of the mouth, the submucosal tissue was separated, and important structures such as the buccal nerve, parotid duct, and facial nerve were protected. The tumor was completely resected while preserving the parotid gland.
Blair S-shaped incision for parotid tumorProcedure or surgery
The Blair S-shaped incision was made through an anterior auricular incision. After cutting the skin, the flap was reflapped. The greater auricular nerve and facial nerve were separated and protected, and the tumor was completely resected.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic-assisted transoral approach for parotid tumor resection | Experimental | A 5-7 cm curvilinear incision was made with electrocautery on the buccal mucosa along the anterior border of the pterygomandibular raphe on the affected side. The mucosal flap was elevated superiorly, with preservation of the parotid duct and buccal nerve. Two assistants were required to maintain retractor elevation, and hold the endoscope. Electrocautery dissection was performed in three dimensions to expose the anterior borders of both the medial pterygoid muscle and masseter muscle, along with the tumor mass. The surgeon manipulated either electrocautery or ultrasonic scalpel for precise dissection, and used forceps to retract or displace muscular and parotid tissues. Hemoclips were applied to achieve hemostasis. Blunt dissection through normal peri-tumoral tissue ensured complete tumor resection while preserving critical structures including facial nerve branches, buccal nerve, and parotid duct. Receives: Procedure: Endoscopic-assisted transoral approach for parotid tumor resection |
| Blair S-shaped incision for parotid tumor | Other | The traditional parotid tumor resection surgery employs a Blair S-shaped incision, starting from the anterior edge of the tragus, extending along the auricle to the earlobe, then curving downward along the posterior border of the mandibular ramus to a point 2-3 cm below the mandibular angle. The skin and subcutaneous tissues are incised to the superficial layer of the parotid fascia, followed by anterior flap elevation while preserving the branches of the greater auricular nerve. The parotid gland and tumor are then exposed, with careful dissection of the facial nerve before removing the tumor and gland. The preservation of critical structures is similar to that in the endoscopic-assisted transoral approach group. A negative-pressure drainage tube is placed at the incision site, and the wound is closed in layers. Receives: Procedure: Blair S-shaped incision for parotid tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS for aesthetic
The assessment of postoperative aesthetics includes the Visual Analogue Scale (VAS); 0-10. 0 indicates a poor result and 10 indicates a good result.
Measured: 1、3、6 months after surgery
aesthetic
The appearance assessment section of the University of Washington Quality of Life Questionnaire (UW-QOL)
Measured: 1、3、6 months after surgery
Secondary outcomes (1)
Incidence of postoperative complications
The proportion of patients with complications such as facial paralysis, salivary fistula, hemorrhage, hematoma, and numbness of the earlobe after the operation among the total number of patients in this group
Measured: 1、3、6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start1 Jan 2023
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Tumor of Parotid GlandStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youyuan Wang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028437
- Sponsor's protocol ID
- SYSJS-2024-075-02
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Endoscopy-assisted Transoral Parotid Gland Tumor Excision Compared With Traditional Operation
- ClinicalTrials.gov ID
- NCT07028437
- Acronym / sponsor ID
- SYSJS-2024-075-02
- Conditions
- Benign Tumor of Parotid Gland, Endoscope-assisted Surgery, Gland Preservation, Minimally Invasive Surgery
- Keywords
- transoral parotid gland tumor excision, Endoscope-assisted, minimally invasive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 19 Jun 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.
Endoscopic-assisted surgery has become a popular technique in salivary gland surgery, particularly for parotid gland tumors. However, this technique has not yet been routinely applied to transoral parotid tumor resection. This retrospective study aimed to evaluate the outcomes of gland-preserving surgery in patients with benign parotid tumors undergoing endoscopic-assisted transoral resection.
The study included 30 patients with benign parotid tumors who underwent gland-preserving tumor resection: 15 underwent endoscopic-assisted transoral resection, while the other 15 underwent conventional tumor resection via the Blair S-shaped incision. Surgical feasibility, perioperative variables, postoperative appearance, and functional outcomes were assessed.
In both groups, all tumors were completely removed with negative margins. No significant differences were observed between the two groups in terms of intraoperative blood loss, postoperative drainage volume, average incision length, or facial nerve injury. However, the endoscopic-assisted transoral group demonstrated superior cosmetic outcomes. No tumor recurrence was observed during the 1-6 month follow-up period.
Therefore, endoscopic-assisted transoral parotid tumor resection is a safe approach for benign parotid tumors, offering both favorable functional and aesthetic results.
Detailed description
The incidence of parotid gland tumors is approximately 1 in 100,000, accounting for 80% of all salivary gland tumors, with about 80% being benign. Parotid tumor resection is a well-established surgical technique. Traditionally, the Blair S-shaped incision has been used, but it leaves noticeable scars on the maxillofacial region, which can be a significant burden for both surgeons and patients. Additionally, postoperative complications such as great auricular nerve injury may occur.
In the mid-20th century, the standard surgical approaches for benign parotid tumors included total parotidectomy (with facial nerve sacrifice) or superficial parotidectomy (preserving the facial nerve), which significantly reduced tumor recurrence rates. However, due to the extensive surgical scope, these procedures were associated with a high incidence of complications such as facial nerve dysfunction, Frey's syndrome, salivary fistula, and facial scar deformities.
In recent years, with growing interest in minimally invasive surgery, studies have found that subtotal parotidectomy for benign parotid tumors not only reduces postoperative complications but also maintains comparable recurrence rates. To meet patients' aesthetic demands, more concealed hairline incisions have gained popularity, as the scars can be hidden behind the ear.
With advancements in minimally invasive techniques for parotid tumor surgery, surgeons have developed various approaches to minimize scarring and reduce complications, including retroauricular sulcus incisions, endoscopic-assisted techniques, and transoral/intraoral resections. Endoscopic-assisted techniques leave minimal or hidden scars postoperatively. The combination of intraoral incisions and endoscopy can further conceal surgical scars, reduce patient trauma, and improve satisfaction-without significant complications compared to traditional transcutaneous approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic-assisted transoral approach for parotid tumor resection | Experimental | Procedure: Endoscopic-assisted transoral approach for parotid tumor resectionA 5-7 cm curvilinear incision was made with electrocautery on the buccal mucosa along the anterior border of the pterygomandibular raphe on the affected side. The mucosal flap was elevated superiorly, with preservation of the parotid duct and buccal nerve. Two assistants were required to maintain retractor elevation, and hold the endoscope. Electrocautery dissection was performed in three dimensions to expose the anterior borders of both the medial pterygoid muscle and masseter muscle, along with the tumor mass. The surgeon manipulated either electrocautery or ultrasonic scalpel for precise dissection, and used forceps to retract or displace muscular and parotid tissues. Hemoclips were applied to achieve hemostasis. Blunt dissection through normal peri-tumoral tissue ensured complete tumor resection while preserving critical structures including facial nerve branches, buccal nerve, and parotid duct. |
| Blair S-shaped incision for parotid tumor | Other | Procedure: Blair S-shaped incision for parotid tumorThe traditional parotid tumor resection surgery employs a Blair S-shaped incision, starting from the anterior edge of the tragus, extending along the auricle to the earlobe, then curving downward along the posterior border of the mandibular ramus to a point 2-3 cm below the mandibular angle. The skin and subcutaneous tissues are incised to the superficial layer of the parotid fascia, followed by anterior flap elevation while preserving the branches of the greater auricular nerve. The parotid gland and tumor are then exposed, with careful dissection of the facial nerve before removing the tumor and gland. The preservation of critical structures is similar to that in the endoscopic-assisted transoral approach group. A negative-pressure drainage tube is placed at the incision site, and the wound is closed in layers. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with primary benign parotid tumors all underwent CT, MRI and ultrasound-guided FNAC examinations of parotid tumors before the operation. All the patients underwent glandular preservation surgery.
Key exclusion criteria (1 listed)
- The tumor diameter is greater than 6cm, has undergone radiotherapy, is a highly malignant tumor, a tumor invading the skin, and a recurrent tumor.
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 |
|---|---|---|
| Endoscopic-assisted transoral approach for parotid tumor resectionThe buccal mucosa was incised in front of the mandibular ligament of the inner wing of the mouth, the submucosal tissue was separated, and important structures such as the buccal nerve, parotid duct, and facial nerve were protected. The tumor was completely resected while preserving the parotid gland. | Procedure or surgery | Endoscopic-assisted transoral approach for parotid tumor resection |
| Blair S-shaped incision for parotid tumorThe Blair S-shaped incision was made through an anterior auricular incision. After cutting the skin, the flap was reflapped. The greater auricular nerve and facial nerve were separated and protected, and the tumor was completely resected. | Procedure or surgery | Blair S-shaped incision for parotid tumor |
Primary outcome
VAS for aesthetic
Time frame: 1、3、6 months after surgery
The assessment of postoperative aesthetics includes the Visual Analogue Scale (VAS); 0-10. 0 indicates a poor result and 10 indicates a good result.
aesthetic
Time frame: 1、3、6 months after surgery
The appearance assessment section of the University of Washington Quality of Life Questionnaire (UW-QOL)
1 secondary outcome
Incidence of postoperative complications
Time frame: 1、3、6 months after surgery
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 19 Jun 2025.
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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 Endoscopic-assisted transoral approach for parotid tumor resection and Blair S-shaped incision for parotid tumor in people with Benign Tumor of Parotid Gland and Endoscope-assisted Surgery, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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: finished, as of the sponsor's last update on 19 Jun 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 China. 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?
VAS for aesthetic (time frame: 1、3、6 months after surgery). The study lists 2 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 19 Jun 2025.