Intra-parotid Facial Nerve Imaging in Parotidectomy

NCT03822728 | Completed

• 1 other identifier: 2017-07-084
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Parotid Tumors; Facial Nerve Paresis

Outcome Measures

Primary Outcomes (1)

• Immediate postoperative facial weakness

  Evaluation of facial function using Facial palsy grading system, immediately after parotidectomy. Measures: House-Brackmann Facial Nerve Grading System (1: Normal, 2: Mild dysfunction, 3: Moderately dysfunction, 4: Moderately severe dysfunction, 5: Severe dysfunction, 6: Total paralysis)

  Postoperative day 1

Secondary Outcomes (1)

• Permanent postoperative facial weakness

  Postoperative 6 months

Study Arms (2)

Without 3D-DESS MRI

NO INTERVENTION

As for deep seated tumors in preoperative CT or US (or tumors in both superficial and deep parotid glands), the patients will undergo surgery without 3D-DESS MRI (currently routine practice).

With 3D-DESS MRI

EXPERIMENTAL

As for deep seated tumors in preoperative CT or US (or tumors in both superficial and deep parotid glands), preoperative 3D-DESS MRI will be additionally performed to delineate the intra-parotid facial nerve.

Diagnostic Test: 3D-DESS MRI (3 dimensional double echo steady state MRI)

Interventions

3D-DESS MRI (3 dimensional double echo steady state MRI) DIAGNOSTIC_TEST

3D-DESS MRI has been reported useful for the intra-parotid facial nerve imaging. It can provide information about the anatomical relationship between the tumor and the facial nerve in the parotid gland.

With 3D-DESS MRI

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

• 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.

  PMID: 21566007 BACKGROUND

MeSH Terms

Conditions

Parotid Neoplasms

Condition Hierarchy (Ancestors)

Salivary Gland Neoplasms; Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Parotid Diseases; Salivary Gland Diseases

Study Officials

• Han-Sin Jeong, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 30, 2019
• Study Start: August 1, 2017
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)