Clinical trial NCT03822728: Intra-parotid Facial Nerve Imaging in Parotidectomy
Official title: Postoperative Facial Weakness in Parotidectomy for Deep Seated Parotid Tumor With or Without Intra-parotid Facial Nerve Imaging (3D Double-Echo Steady-State With Water Excitation MRI Imaging)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parotid Tumors
Facial Nerve Paresis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Primary outcomes:
measure: Immediate postoperative facial weakness
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Permanent postoperative facial weakness
timeFrame: Postoperative 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Han-Sin Jeong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Qin Y, Zhang J, Li P, Wang Y. 3D double-echo steady-state with water excitation MR imaging of the intraparotid facial nerve at 1.5T: a pilot study. AJNR Am J Neuroradiol. 2011 Aug;32(7):1167-72. doi: 10.3174/ajnr.A2480. Epub 2011 May 12.