NCT07028437

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

2.2 years

First QC Date

June 11, 2025

Last Update Submit

June 11, 2025

Conditions

Keywords

transoral parotid gland tumor excisionEndoscope-assistedminimally invasive

Outcome Measures

Primary Outcomes (2)

  • 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.

    1、3、6 months after surgery

  • aesthetic

    The appearance assessment section of the University of Washington Quality of Life Questionnaire (UW-QOL)

    1、3、6 months after surgery

Secondary Outcomes (1)

  • Incidence of postoperative complications

    1、3、6 months after surgery

Study Arms (2)

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.

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.

Procedure: Blair S-shaped incision for parotid tumor

Interventions

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.

Endoscopic-assisted transoral approach for parotid tumor resection

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.

Blair S-shaped incision for parotid tumor

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • The tumor diameter is greater than 6cm, has undergone radiotherapy, is a highly malignant tumor, a tumor invading the skin, and a recurrent tumor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 19, 2025

Study Start

January 1, 2023

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

June 19, 2025

Record last verified: 2025-06

Locations