<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/NCT03257930</url>
  </required_header>
  <id_info>
    <org_study_id>Ethanol Injection</org_study_id>
    <nct_id>NCT03257930</nct_id>
  </id_info>
  <brief_title>Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules</brief_title>
  <official_title>Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>hassan harby mohamed</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Use of ethanol injection in treatment of cystic thyroid nodule&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thyroid nodules are common discreet lesions in the parenchyma of thyroid gland which can&#xD;
      either be palpated or made out during imaging like ultrasonography (USG).Clinically palpable&#xD;
      thyroid nodules have a prevalence of 4-7% in the general population . However, the prevalence&#xD;
      increases to 20-76% when USG is used for detection.&#xD;
&#xD;
      Goiter and the associated thyroid nodules result in anxiety, cosmetic disfigurement, and&#xD;
      rarely compressive symptoms necessitating surgical removal, a procedure inherently associated&#xD;
      with risks and complications Percutaneous sclerotherapy has been suggested to be an effective&#xD;
      alternative, especially in patients with cystic nodules. Simple cystic (purely cystic)&#xD;
      constitutes 6-28% of all thyroid nodules, are usually benign, filled with cellular debris or&#xD;
      blood, and are a result of degeneration or hemorrhage into a hyperplastic nodule.&#xD;
&#xD;
      Among the various compounds (sodium tetradocyl sulfate, hydroxypolyethoxydodecan,&#xD;
      tetracycline, and ethanol) tried for sclerosis of cystic thyroid nodules, outcomes are best&#xD;
      and most studied with ethanol. However, data on outcomes of percutaneous aspiration and&#xD;
      ethanol injection (PEI) in resolution of thyroid nodules is highly variable in different&#xD;
      studies (success rate: 38-85%), which may be due to different populations studied and the&#xD;
      heterogeneous nature of thyroid nodules evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 11, 2017</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 11, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of volume of the cyst about 96.9%</measure>
    <time_frame>Reduction of volume of the cyst about 96.9% within 6 month</time_frame>
    <description>Reduction of volume of the cyst about 96.9%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>symptomatic improvement</measure>
    <time_frame>3 month</time_frame>
    <description>cosmetic improvement of the ugly appearance of the cyst from the neck</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Thyroid Nodule</condition>
  <arm_group>
    <arm_group_label>injection of ethanol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>use of ethanol injection in the treatment of cystic thyroid nodule</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ethanol injection</intervention_name>
    <description>inject ethanol in cystic thyroid nodule and follow up until complete recovery</description>
    <arm_group_label>injection of ethanol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult male or female patient with cystic thyroid nodule&#xD;
&#xD;
          2. Presence of pressure symptoms or cosmetic problems&#xD;
&#xD;
          3. Benign lesions confirmed by histopathological examination by FNAC.&#xD;
&#xD;
          4. Serum levels of thyroid hormone thyrotropin, within normal limits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Nodules showing malignant features(ie, speculated margin, markedly hypo echoic, micro-&#xD;
             or macro calcifications) at US&#xD;
&#xD;
          2. solid thyroid nodule&#xD;
&#xD;
          3. mixed thyroid nodule(cystic with solid component)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assiut University</name>
      <address>
        <city>Assiut</city>
        <zip>71511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Vogel D, Durham AC, de Marcillac GD. Metastable aggregates in the polymerisation of tobacco-mosaic-virus protein. Eur J Biochem. 1977 Sep 15;79(1):161-71. doi: 10.1111/j.1432-1033.1977.tb11794.x. No abstract available.</citation>
    <PMID>21087</PMID>
  </reference>
  <reference>
    <citation>Monzani F, Lippi F, Goletti O, Del Guerra P, Caraccio N, Lippolis PV, Baschieri L, Pinchera A. Percutaneous aspiration and ethanol sclerotherapy for thyroid cysts. J Clin Endocrinol Metab. 1994 Mar;78(3):800-2. doi: 10.1210/jcem.78.3.8126160.</citation>
    <PMID>8126160</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>May 13, 2020</last_update_submitted>
  <last_update_submitted_qc>May 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>hassan harby mohamed</investigator_full_name>
    <investigator_title>general surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Nodule</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ethanol</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03257930
org study id: Ethanol Injection
nct id: NCT03257930
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Use of ethanol injection in treatment of cystic thyroid nodule
Thyroid nodules are common discreet lesions in the parenchyma of thyroid gland which can
      either be palpated or made out during imaging like ultrasonography (USG).Clinically palpable
      thyroid nodules have a prevalence of 4-7% in the general population . However, the prevalence
      increases to 20-76% when USG is used for detection.

      Goiter and the associated thyroid nodules result in anxiety, cosmetic disfigurement, and
      rarely compressive symptoms necessitating surgical removal, a procedure inherently associated
      with risks and complications Percutaneous sclerotherapy has been suggested to be an effective
      alternative, especially in patients with cystic nodules. Simple cystic (purely cystic)
      constitutes 6-28% of all thyroid nodules, are usually benign, filled with cellular debris or
      blood, and are a result of degeneration or hemorrhage into a hyperplastic nodule.

      Among the various compounds (sodium tetradocyl sulfate, hydroxypolyethoxydodecan,
      tetracycline, and ethanol) tried for sclerosis of cystic thyroid nodules, outcomes are best
      and most studied with ethanol. However, data on outcomes of percutaneous aspiration and
      ethanol injection (PEI) in resolution of thyroid nodules is highly variable in different
      studies (success rate: 38-85%), which may be due to different populations studied and the
      heterogeneous nature of thyroid nodules evaluated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reduction of volume of the cyst about 96.9%
time frame: Reduction of volume of the cyst about 96.9% within 6 month
description: Reduction of volume of the cyst about 96.9%
measure: symptomatic improvement
time frame: 3 month
description: cosmetic improvement of the ugly appearance of the cyst from the neck
arm group label: injection of ethanol
arm group type: Experimental
description: use of ethanol injection in the treatment of cystic thyroid nodule
intervention type: Drug
intervention name: ethanol injection
description: inject ethanol in cystic thyroid nodule and follow up until complete recovery
arm group label: injection of ethanol
criteria: 
gender: All
minimum age: 15 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
citation: Vogel D, Durham AC, de Marcillac GD. Metastable aggregates in the polymerisation of tobacco-mosaic-virus protein. Eur J Biochem. 1977 Sep 15;79(1):161-71. doi: 10.1111/j.1432-1033.1977.tb11794.x. No abstract available.
PMID: 21087
citation: Monzani F, Lippi F, Goletti O, Del Guerra P, Caraccio N, Lippolis PV, Baschieri L, Pinchera A. Percutaneous aspiration and ethanol sclerotherapy for thyroid cysts. J Clin Endocrinol Metab. 1994 Mar;78(3):800-2. doi: 10.1210/jcem.78.3.8126160.
PMID: 8126160
responsible party type: Sponsor-Investigator
investigator affiliation: Assiut University
investigator full name: hassan harby mohamed
investigator title: general surgery
mesh term: Thyroid Nodule
mesh term: Thyroid Diseases
mesh term: Ethanol