Parotid TumorsNCT03822728
Intra-parotid Facial Nerve Imaging in Parotidectomy
A study testing 3D-DESS MRI (3 dimensional double echo steady state MRI) in people with Parotid Tumors and Facial Nerve Paresis, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Parotid Tumors, Facial Nerve Paresis
- What is being tested?
- 3D-DESS MRI (3 dimensional double echo steady state MRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2017to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Parotid Tumors, Facial Nerve Paresis
- Being tested
- 3D-DESS MRI (3 dimensional double echo steady state MRI)
- Medical subject headings
- Parotid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: 3D-DESS MRI (3 dimensional double echo steady state MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Postoperative day 1
Secondary outcomes (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)
Measured: Postoperative 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Aug 2017
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parotid TumorsStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han-Sin Jeong, Samsung Medical Center
- Investigators
- Han-Sin Jeong, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822728
- Sponsor's protocol ID
- 2017-07-084
- Status last verified
- Nov 2023
- First submitted
- 29 Jan 2019
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will make our participant data available to other researchers after completion of this study.
Publications
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.
PubMed 21566007
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03822728
- Acronym / sponsor ID
- 2017-07-084
- Conditions
- Parotid Tumors, Facial Nerve Paresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Diagnostic Test: 3D-DESS MRI (3 dimensional double echo steady state MRI)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | With 3D-DESS MRI |
Primary outcome
Immediate postoperative facial weakness
Time frame: Postoperative day 1
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)
1 secondary outcome
Permanent postoperative facial weakness
Time frame: Postoperative 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Background: PubMed 21566007Qin 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.
- Individual participant dataSharing planned: No. The investigators will make our participant data available to other researchers after completion of this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han-Sin Jeong, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-DESS MRI (3 dimensional double echo steady state MRI) in people with Parotid Tumors and Facial Nerve Paresis, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate postoperative facial weakness (time frame: Postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03822728, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.