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Intra-parotid Facial Nerve Imaging in Parotidectomy

Primary Purpose

Parotid Tumors, Facial Nerve Paresis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
3D-DESS MRI (3 dimensional double echo steady state MRI)
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parotid Tumors

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Without 3D-DESS MRI

With 3D-DESS MRI

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Full Information

First Posted
January 29, 2019
Last Updated
August 31, 2021
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03822728
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parotid Tumors, Facial Nerve Paresis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Without 3D-DESS MRI
Arm Type
No Intervention
Arm Description
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).
Arm Title
With 3D-DESS MRI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
3D-DESS MRI (3 dimensional double echo steady state MRI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Immediate postoperative facial weakness
Description
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
Secondary Outcome Measure Information:
Title
Permanent postoperative facial weakness
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han-Sin Jeong, MD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators will make our participant data available to other researchers after completion of this study.
Citations:
PubMed Identifier
21566007
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.
Results Reference
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Intra-parotid Facial Nerve Imaging in Parotidectomy

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