An interventional study of 3D-DESS MRI (3 dimensional double echo steady state MRI) in Parotid Tumors and Facial Nerve Paresis, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-11-27.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Prevention
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.
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.
27 studies on the registry are indexed under Parotid Neoplasms; 7 are open to participants now.
This study's enrollment of 270 is above the median of 55 across 20 interventional studies indexed under Parotid Neoplasms.
Browse Parotid Neoplasms studies →Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Exclusion Criteria:
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).
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)
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.
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)
Time frame: Postoperative day 1
Permanent postoperative facial weakness
Evaluation of facial function using Facial palsy grading system, at 6 months 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)
Time frame: Postoperative 6 months
Plan to share: No — The investigators will make our participant data available to other researchers after completion of this study.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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