<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03822728</url>
  </required_header>
  <id_info>
    <org_study_id>2017-07-084</org_study_id>
    <nct_id>NCT03822728</nct_id>
  </id_info>
  <brief_title>Intra-parotid Facial Nerve Imaging in Parotidectomy</brief_title>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators will evaluate the clinical usefulness of 3 dimensional&#xD;
      double echo steady state MRI (3D-DESS MRI) for functional preservation of the facial nerve&#xD;
      during parotidectomy. Preoperative 3D-DESS MRI imaging can provide information about the&#xD;
      anatomical relationship between the tumor and the facial nerve in the parotid gland.&#xD;
&#xD;
      Because the risk of postoperative facial weakness is relatively high in the deep-seated&#xD;
      parotid tumors, the investigators will exclude the patients with the superficial parotid&#xD;
      tumors (determined by preoperative CT or US) and only include the patients with deep seated&#xD;
      parotid tumors in this trial.&#xD;
&#xD;
      The main outcome of our study is the incidence of immediate postoperative facial weakness,&#xD;
      and the secondary outcome is the incidence of facial weakness at postoperative 6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgical removal of tumors arising from the parotid gland (benign or malignant) is treatment&#xD;
      of choice. However, the most detrimental complication of parotidectomy is facial weakness or&#xD;
      facial nerve palsy, because the facial nerve crosses in the mid-portion of the parotid gland.&#xD;
&#xD;
      Numerous studies indicated the incidence of temporary facial weakness as 5-45% and permanent&#xD;
      facial palsy as 0-15% after parotidectomy. To reduce this complication, the investigators&#xD;
      will apply the modern technique of MRI imaging to inform the anatomical relationship between&#xD;
      the tumor and the facial nerve within the parotid gland preoperatively. Three dimensional&#xD;
      double echo steady state MRI imaging (3D-DESS MRI) has been reported useful for the&#xD;
      intra-parotid facial nerve imaging.&#xD;
&#xD;
      Thus, the investigators will evaluate the clinical usefulness of 3D-DESS MRI for functional&#xD;
      preservation of the facial nerve during parotidectomy. Preoperative 3D-DESS MRI imaging can&#xD;
      provide information about the anatomical relationship between the tumor and the facial nerve&#xD;
      in the parotid gland.&#xD;
&#xD;
      In the retrospective series, the investigators found that there were 25.6% temporary facial&#xD;
      weakness and 10.3% permanent (&gt; 6 months) facial weakness after parotidectomy for deep-seated&#xD;
      parotid tumors (plus tumors located in both deep and superficial parotid gland); whereas 6.7%&#xD;
      and 3.6% facial weakness respectively for superficially located parotid tumors. Because the&#xD;
      risk of postoperative facial weakness is relatively high in the deep-seated parotid tumors,&#xD;
      the investigators will exclude the patients with the superficial parotid tumors (determined&#xD;
      by preoperative CT or US) and only include the patients with deep seated parotid tumors in&#xD;
      this trial.&#xD;
&#xD;
      The main outcome of our study is the incidence of immediate postoperative facial weakness,&#xD;
      and the secondary outcome is the incidence of facial weakness at postoperative 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Immediate postoperative facial weakness</measure>
    <time_frame>Postoperative day 1</time_frame>
    <description>Evaluation of facial function using Facial palsy grading system, immediately after parotidectomy.&#xD;
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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Permanent postoperative facial weakness</measure>
    <time_frame>Postoperative 6 months</time_frame>
    <description>Evaluation of facial function using Facial palsy grading system, at 6 months after parotidectomy.&#xD;
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)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">270</enrollment>
  <condition>Parotid Tumors</condition>
  <condition>Facial Nerve Paresis</condition>
  <arm_group>
    <arm_group_label>Without 3D-DESS MRI</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>With 3D-DESS MRI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>3D-DESS MRI (3 dimensional double echo steady state MRI)</intervention_name>
    <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.</description>
    <arm_group_label>With 3D-DESS MRI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parotid tumors subject to the surgery (parotidectomy)&#xD;
&#xD;
          -  Parotid deep lobe tumors or tumor located in both superficial and deep parotid glands&#xD;
             (Tumor medial to the facial nerve line, a line connecting the lateral border of&#xD;
             mandible and the posterior belly of digastric muscle on CT scans or tumors crossing&#xD;
             the facial nerve line on CT scans)&#xD;
&#xD;
          -  Benign or malignant tumors&#xD;
&#xD;
          -  Any size of parotid tumors&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Superficially located parotid tumor on CT or US (Tumor lateral to the facial nerve&#xD;
             line, a line connecting the lateral border of mandible and the posterior belly of&#xD;
             digastric muscle on CT scans)&#xD;
&#xD;
          -  Previous parotid surgery in the affected parotid gland (Revision parotid surgery)&#xD;
&#xD;
          -  Preoperative facial nerve palsy&#xD;
&#xD;
          -  Cases with the facial nerve sacrifice during surgery for oncological purpose&#xD;
             (malignancy)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Han-Sin Jeong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>21566007</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>August 31, 2021</last_update_submitted>
  <last_update_submitted_qc>August 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Han-Sin Jeong</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parotid Neoplasms</mesh_term>
    <mesh_term>Paresis</mesh_term>
    <mesh_term>Facies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The investigators will make our participant data available to other researchers after completion of this study.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03822728
org study id: 2017-07-084
nct id: NCT03822728
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Immediate postoperative facial weakness
time frame: Postoperative day 1
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)
measure: Permanent postoperative facial weakness
time frame: Postoperative 6 months
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)
arm group label: Without 3D-DESS MRI
arm group type: No Intervention
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 group label: With 3D-DESS MRI
arm group type: Experimental
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: 3D-DESS MRI (3 dimensional double echo steady state MRI)
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.
arm group label: With 3D-DESS MRI
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Han-Sin Jeong, MD
role: Principal Investigator
affiliation: Samsung Medical Center
facility: 
country: Korea, Republic of
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.
PMID: 21566007
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Han-Sin Jeong
investigator title: Professor
mesh term: Parotid Neoplasms
mesh term: Paresis
mesh term: Facies
sharing ipd: No
ipd description: The investigators will make our participant data available to other researchers after completion of this study.