NCT03822728

Intra-parotid Facial Nerve Imaging in Parotidectomy

Completed NA Last updated 27 November 2023

What this trial tests

NA trial testing 3D-DESS MRI (3 dimensional double echo steady state MRI) in Parotid Tumors in 270 participants. Completed in 31 July 2021.

Timeline

1 August 2017

Primary endpoint
31 July 2021

31 July 2021

Quick facts

Lead sponsor	Samsung Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	270
Start date	1 August 2017
Primary completion	31 July 2021
Estimated completion	31 July 2021
Sites	1 location across South Korea

Drugs / interventions tested

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

Conditions studied

• Parotid Tumors — all drugs for Parotid Tumors →
• Facial Nerve Paresis — all drugs for Facial Nerve Paresis →

Sponsor

Samsung Medical Center

Who can join

Adults 18 to 70, any sex, with Parotid Tumors or Facial Nerve Paresis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Imaging of Facial Nerve With 3D-DESS-WE-MRI Before Parotidectomy: Impact on Surgical Outcomes.
   Jeong HS, Kim Y, Kim HJ, Kim HJ, et al · · 2023 · cited 12× · PMID 37634641 · DOI 10.3348/kjr.2022.0850