<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/NCT03268785</url>
  </required_header>
  <id_info>
    <org_study_id>KY20162049-X-1</org_study_id>
    <nct_id>NCT03268785</nct_id>
  </id_info>
  <brief_title>Intra-operative Rapid Identification of Lymph Node and Parathyroid</brief_title>
  <official_title>Intra-operative Rapid Identification of Lymph Node and Parathyroid by Fine Needle Puncture for Thyroid Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xijing Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      During surgery, a fine needle puncture was proceeded when suspicious nodes was found by&#xD;
      clinician. Repeat the punction for 2-3 times from different orientation and then, Diff-quik&#xD;
      staining or PTH immunochromatographic assay were proceeded for lymph node or parathyroid&#xD;
      glands identification. Post-operative pathology outcome was considered as golden standard.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the experiment group, when suspicious parathyroid glands or lymph nodes were observed, a&#xD;
      22 G needle was applied for in situ puncture at a 45 degree angle. The needle was initially&#xD;
      thrust into the gland for 0.2 mm, and then we advanced the needle for another 0.2mm while&#xD;
      gently withdrawing the plunger of the syringe and maintaining negative pressure. At this&#xD;
      point, there has parathyroid tissue been adsorbed in the needle. Repeat this process in two&#xD;
      different directions to guarantee the simple volume.&#xD;
&#xD;
      When cell smears finished, the smears were fixed in stationary liquid within 2-4 seconds for&#xD;
      5-20 seconds, and then Diff-Quik (DQ) staining technique was proceeded for rapid&#xD;
      identification using Diff-Quik staining kit according to the instruction. After the following&#xD;
      Diff-quick staining for 30 seconds, we can make out parathyroid cells and lymph nodes under&#xD;
      high power microscope.&#xD;
&#xD;
      In addition,PTH immunochromatographic assay kit can also be used for parathyroid glands&#xD;
      detection. Using indicator paper to dip to the punctured tissue, the existance of parathyroid&#xD;
      glands could be ensured.&#xD;
&#xD;
      HE (Hematoxylin and Eosin) staining was used for pathological verification of suspicious&#xD;
      nodes found during surgery. The suspicious nodes occurred in surgery were isolated and fixed&#xD;
      with 4% paraformaldehyde for 12 h, embedded in parafﬁn and cut into 3-µm serial sections.&#xD;
      Corresponding sections were stained with hematoxylin (BASO Diagnostics Inc. Zhuhai) for 10&#xD;
      min at room temperature. Then, sections were washed with running water. Subsequently,&#xD;
      sections were washed with Scott promote blue liquid for 1 min, 1% hydrochloric acid alcohol&#xD;
      differentiation liquid for 20 s, and Scott promote blue liquid for 1 min. Then, sections were&#xD;
      stained with eosin (BASO Diagnostics Inc. Zhuhai) for 30 s. Sections were washed with running&#xD;
      water and sealed for observation. Finally, sections were observed by Image-Pro Plus 5.0&#xD;
      software (Media Cybernetics, Inc., Bethesda, MD, USA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2016</start_date>
  <completion_date type="Anticipated">August 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2018</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>Sequential Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>hypocalcemia</measure>
    <time_frame>7 days after surgery</time_frame>
    <description>Rate of hypocalcemia after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Accuracy,sensitivity and specificity</measure>
    <time_frame>10 day after operation</time_frame>
    <description>Accuracy,sensitivity and specificity of intraoperative identification method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Life quality</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>The EORTC QLQ-C30 questionnaire was used to assess the life quality of participances. We calculate the score from 5 functional aspects according to the questionnnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>operation time</measure>
    <time_frame>During the operation</time_frame>
    <description>Record the identification time of this novel method and the whole operation time</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Thyroid Cancer</condition>
  <condition>Parathyroid; Absent</condition>
  <condition>Hypocalcemia</condition>
  <condition>Hypoparathyroidism Postprocedural</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Previous admitted patients who were given conventional thyroidectomy combined with central neck lymph node dissection, without intra-operative nodes identification were enrolled into control group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Newly admitted patients,from august 2016 to august 2018, who were given thyroidectomy combined with central neck lymph node dissection, with intra-operative identification of suspicious lymph nodes or parathyroid glands were regarded as experimental group.Intraoperative identification method includes Diff-quik staining and PTH test assay. 200 participants were planed for enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Intraoperative identification method</intervention_name>
    <description>After needle pucture of suspicious nodes, Diff-quik staining was used to distinct lymph nodes and parathyroid glands. PTH test assay was used for parathyroid identification. Postoperative HE staining were applied as golden standard.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Thyroid cancer patients undergoing thyroid cancer surgery Preoperative examination were&#xD;
        all ready for surgery Diagnosed with thyroid cancer by fine needle puncture before surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patients enrolled into another clinical study Pregnant patients Patients diagnosed with&#xD;
        another life-treating disease Patients with surgical contraindication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rui Ling, Prof.</last_name>
    <phone>029-84775271</phone>
    <email>lingrui0105@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Meiling Huang, MD</last_name>
    <phone>029-84775271</phone>
    <email>huangmeiling@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Xijing hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rui Ling</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xijing Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juliang Zhang, Doctor</last_name>
      <phone>+862984775271</phone>
      <email>zhangjl@fmmu.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Juliang Zhang, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=An+intact+parathyroid+hormone-based+protocol+for+the+prevention+and+treatment+of+symptomatic+hypocalcemia+after+thyroidectomy</url>
    <description>An intact parathyroid hormone-based protocol for the prevention and treatment of symptomatic hypocalcemia after thyroidectomy</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=Preserving+function+and+quality+of+life+after+thyroid+and+parathyroid+surgery</url>
    <description>Preserving function and quality of life after thyroid and parathyroid surgery.</description>
  </link>
  <reference>
    <citation>Adler JT, Sippel RS, Schaefer S, Chen H. Preserving function and quality of life after thyroid and parathyroid surgery. Lancet Oncol. 2008 Nov;9(11):1069-75. doi: 10.1016/S1470-2045(08)70276-6.</citation>
    <PMID>19012855</PMID>
  </reference>
  <reference>
    <citation>Carter Y, Chen H, Sippel RS. An intact parathyroid hormone-based protocol for the prevention and treatment of symptomatic hypocalcemia after thyroidectomy. J Surg Res. 2014 Jan;186(1):23-8. doi: 10.1016/j.jss.2013.09.026. Epub 2013 Oct 8.</citation>
    <PMID>24144426</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xijing Hospital</investigator_affiliation>
    <investigator_full_name>Ling Rui</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Parathyroid glands</keyword>
  <keyword>Needle puncture</keyword>
  <keyword>Diff-quik staining</keyword>
  <keyword>PTH test assay</keyword>
  <keyword>Thyroid cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Hypocalcemia</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
    <mesh_term>Hypoparathyroidism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03268785
org study id: KY20162049-X-1
nct id: NCT03268785
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
During surgery, a fine needle puncture was proceeded when suspicious nodes was found by
      clinician. Repeat the punction for 2-3 times from different orientation and then, Diff-quik
      staining or PTH immunochromatographic assay were proceeded for lymph node or parathyroid
      glands identification. Post-operative pathology outcome was considered as golden standard.
In the experiment group, when suspicious parathyroid glands or lymph nodes were observed, a
      22 G needle was applied for in situ puncture at a 45 degree angle. The needle was initially
      thrust into the gland for 0.2 mm, and then we advanced the needle for another 0.2mm while
      gently withdrawing the plunger of the syringe and maintaining negative pressure. At this
      point, there has parathyroid tissue been adsorbed in the needle. Repeat this process in two
      different directions to guarantee the simple volume.

      When cell smears finished, the smears were fixed in stationary liquid within 2-4 seconds for
      5-20 seconds, and then Diff-Quik (DQ) staining technique was proceeded for rapid
      identification using Diff-Quik staining kit according to the instruction. After the following
      Diff-quick staining for 30 seconds, we can make out parathyroid cells and lymph nodes under
      high power microscope.

      In addition,PTH immunochromatographic assay kit can also be used for parathyroid glands
      detection. Using indicator paper to dip to the punctured tissue, the existance of parathyroid
      glands could be ensured.

      HE (Hematoxylin and Eosin) staining was used for pathological verification of suspicious
      nodes found during surgery. The suspicious nodes occurred in surgery were isolated and fixed
      with 4% paraformaldehyde for 12 h, embedded in parafﬁn and cut into 3-µm serial sections.
      Corresponding sections were stained with hematoxylin (BASO Diagnostics Inc. Zhuhai) for 10
      min at room temperature. Then, sections were washed with running water. Subsequently,
      sections were washed with Scott promote blue liquid for 1 min, 1% hydrochloric acid alcohol
      differentiation liquid for 20 s, and Scott promote blue liquid for 1 min. Then, sections were
      stained with eosin (BASO Diagnostics Inc. Zhuhai) for 30 s. Sections were washed with running
      water and sealed for observation. Finally, sections were observed by Image-Pro Plus 5.0
      software (Media Cybernetics, Inc., Bethesda, MD, USA).
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: hypocalcemia
time frame: 7 days after surgery
description: Rate of hypocalcemia after surgery
measure: Accuracy,sensitivity and specificity
time frame: 10 day after operation
description: Accuracy,sensitivity and specificity of intraoperative identification method
measure: Life quality
time frame: 3 months after surgery
description: The EORTC QLQ-C30 questionnaire was used to assess the life quality of participances. We calculate the score from 5 functional aspects according to the questionnnaire.
measure: operation time
time frame: During the operation
description: Record the identification time of this novel method and the whole operation time
arm group label: Control
arm group type: No Intervention
description: Previous admitted patients who were given conventional thyroidectomy combined with central neck lymph node dissection, without intra-operative nodes identification were enrolled into control group.
arm group label: Experimental group
arm group type: Experimental
description: Newly admitted patients,from august 2016 to august 2018, who were given thyroidectomy combined with central neck lymph node dissection, with intra-operative identification of suspicious lymph nodes or parathyroid glands were regarded as experimental group.Intraoperative identification method includes Diff-quik staining and PTH test assay. 200 participants were planed for enrollment.
intervention type: Diagnostic Test
intervention name: Intraoperative identification method
description: After needle pucture of suspicious nodes, Diff-quik staining was used to distinct lymph nodes and parathyroid glands. PTH test assay was used for parathyroid identification. Postoperative HE staining were applied as golden standard.
arm group label: Experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rui Ling, Prof.
phone: 029-84775271
email: lingrui0105@163.com
last name: Meiling Huang, MD
phone: 029-84775271
email: huangmeiling@126.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
country: China
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=An+intact+parathyroid+hormone-based+protocol+for+the+prevention+and+treatment+of+symptomatic+hypocalcemia+after+thyroidectomy
description: An intact parathyroid hormone-based protocol for the prevention and treatment of symptomatic hypocalcemia after thyroidectomy
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=Preserving+function+and+quality+of+life+after+thyroid+and+parathyroid+surgery
description: Preserving function and quality of life after thyroid and parathyroid surgery.
citation: Adler JT, Sippel RS, Schaefer S, Chen H. Preserving function and quality of life after thyroid and parathyroid surgery. Lancet Oncol. 2008 Nov;9(11):1069-75. doi: 10.1016/S1470-2045(08)70276-6.
PMID: 19012855
citation: Carter Y, Chen H, Sippel RS. An intact parathyroid hormone-based protocol for the prevention and treatment of symptomatic hypocalcemia after thyroidectomy. J Surg Res. 2014 Jan;186(1):23-8. doi: 10.1016/j.jss.2013.09.026. Epub 2013 Oct 8.
PMID: 24144426
responsible party type: Principal Investigator
investigator affiliation: Xijing Hospital
investigator full name: Ling Rui
investigator title: Professor
mesh term: Thyroid Neoplasms
mesh term: Hypocalcemia
mesh term: Thyroid Diseases
mesh term: Hypoparathyroidism
sharing ipd: No