Intra-parotid Facial Nerve Imaging in Parotidectomy

  • STATUS
    Recruiting
  • days left to enroll
    80
  • participants needed
    182
  • sponsor
    Samsung Medical Center
Updated on 28 January 2021

Summary

In this study, the investigators will evaluate the clinical usefulness of 3 dimensional double echo steady state MRI (3D-DESS MRI) for functional preservation of the facial nerve during parotidectomy. Preoperative 3D-DESS MRI imaging can provide information about the anatomical relationship between the tumor and the facial nerve in the parotid gland.

Because the risk of postoperative facial weakness is relatively high in the deep-seated parotid tumors, the investigators will exclude the patients with the superficial parotid tumors (determined by preoperative CT or US) and only include the patients with deep seated parotid tumors in this trial.

The main outcome of our study is the incidence of immediate postoperative facial weakness, and the secondary outcome is the incidence of facial weakness at postoperative 6 months.

Description

Surgical removal of tumors arising from the parotid gland (benign or malignant) is treatment of choice. However, the most detrimental complication of parotidectomy is facial weakness or facial nerve palsy, because the facial nerve crosses in the mid-portion of the parotid gland.

Numerous studies indicated the incidence of temporary facial weakness as 5-45% and permanent facial palsy as 0-15% after parotidectomy. To reduce this complication, the investigators will apply the modern technique of MRI imaging to inform the anatomical relationship between the tumor and the facial nerve within the parotid gland preoperatively. Three dimensional double echo steady state MRI imaging (3D-DESS MRI) has been reported useful for the intra-parotid facial nerve imaging.

Thus, the investigators will evaluate the clinical usefulness of 3D-DESS MRI for functional preservation of the facial nerve during parotidectomy. Preoperative 3D-DESS MRI imaging can provide information about the anatomical relationship between the tumor and the facial nerve in the parotid gland.

In the retrospective series, the investigators found that there were 25.6% temporary facial weakness and 10.3% permanent (> 6 months) facial weakness after parotidectomy for deep-seated parotid tumors (plus tumors located in both deep and superficial parotid gland); whereas 6.7% and 3.6% facial weakness respectively for superficially located parotid tumors. Because the risk of postoperative facial weakness is relatively high in the deep-seated parotid tumors, the investigators will exclude the patients with the superficial parotid tumors (determined by preoperative CT or US) and only include the patients with deep seated parotid tumors in this trial.

The main outcome of our study is the incidence of immediate postoperative facial weakness, and the secondary outcome is the incidence of facial weakness at postoperative 6 months.

Details
Condition Malignant neoplasm of parotid gland, Facial Nerve Paresis
Treatment 3D-DESS MRI (3 dimensional double echo steady state MRI)
Clinical Study IdentifierNCT03822728
SponsorSamsung Medical Center
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have any of these conditions: Facial Nerve Paresis or Malignant neoplasm of parotid gland?
Parotid tumors subject to the surgery (parotidectomy)
Parotid deep lobe tumors or tumor located in both superficial and deep parotid glands (Tumor medial to the facial nerve line, a line connecting the lateral border of mandible and the posterior belly of digastric muscle on CT scans or tumors crossing the facial nerve line on CT scans)
Benign or malignant tumors
Any size of parotid tumors

Exclusion Criteria

Superficially located parotid tumor on CT or US (Tumor lateral to the facial nerve line, a line connecting the lateral border of mandible and the posterior belly of digastric muscle on CT scans)
Previous parotid surgery in the affected parotid gland (Revision parotid surgery)
Preoperative facial nerve palsy
Cases with the facial nerve sacrifice during surgery for oncological purpose (malignancy)
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