<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/NCT02190994</url>
  </required_header>
  <id_info>
    <org_study_id>WestChina-2013137</org_study_id>
    <nct_id>NCT02190994</nct_id>
  </id_info>
  <brief_title>Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions</brief_title>
  <official_title>Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West China Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this four-arm randomized controlled study is to determine whether eliminating&#xD;
      glucocorticoids (GC) replacement in perioperative period in surgical patients with sellar&#xD;
      lesion could result in similar or better outcomes comparing to traditional replacement&#xD;
      therapy, regarding postoperative recovery of pituitary function and other postoperative&#xD;
      complications (infection, pain, quality of life, recurrence). Surgical patients of our center&#xD;
      with MRI-confirmed diagnosis of sellar lesion will be enrolled, insulin tolerance test (ITT)&#xD;
      will be performed for assessment of the pituitary function at enrollment. Patients with&#xD;
      normal pituitary function will be randomized into non-GC replacement group (group A) and&#xD;
      low-dose GC replacement group (group B), while patients with impaired pituitary function will&#xD;
      be randomized into low-dose GC replacement group (group C) and high-dose GC replacement group&#xD;
      (group D). The primary outcome is the hypothalamic-pituitary-adrenal (HPA) -axis function of&#xD;
      the patients, evaluated by plasma cortisol and adrenocorticotropic hormone (ACTH) levels. The&#xD;
      secondary outcomes include the hypothalamic-pituitary-thyroid (HPT) axis function (TSH,&#xD;
      thyroid-stimulating hormone, free T3, free T4), postoperative water-electrolyte balance,&#xD;
      infection, recurrence and health-related quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2013</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">August 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline plasma cortisol level</measure>
    <time_frame>1, 3, 5, 7, 30, 90, 180, 360 days post-op</time_frame>
    <description>Plasma cortisol at 8:00, 16:00, 24:00 respectively</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline plasma ACTH level</measure>
    <time_frame>1, 3, 5, 7, 30, 90, 180, 360 days post-op</time_frame>
    <description>ACTH at 8:00;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline 24-hour urine free cortisol</measure>
    <time_frame>1, 3, 5, 7, 30, 90, 180, 360 days post-op</time_frame>
    <description>24-hour urine free cortisol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline insulin tolerance test result</measure>
    <time_frame>7, 30, 90 days post-op</time_frame>
    <description>insulin tolerance test result</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline plasma TSH level</measure>
    <time_frame>1, 3, 5, 7, 30, 90, 180, 360 days post-op</time_frame>
    <description>plasma TSH level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sodium, potassium concentration in the blood and urine</measure>
    <time_frame>Daily post-op,for the duration of hospital stay, an expected average of 7 days</time_frame>
    <description>Concentration of sodium, potassium in the blood and urine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with postoperative infection</measure>
    <time_frame>For the duration of hospital stay, an expected average of 7 days</time_frame>
    <description>Routine blood test, body temperature fluctuation, cerebrospinal fluid test if necessary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline health-related quality of life</measure>
    <time_frame>7, 30, 90 days post-op</time_frame>
    <description>The 15-Dimensions measure of health-related quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with recurred tumor</measure>
    <time_frame>3,6,12 months after surgery</time_frame>
    <description>Enhanced MRI scan of the sellar region.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline plasma free T3 level</measure>
    <time_frame>1, 3, 5, 7, 30, 90, 180, 360 days post-op</time_frame>
    <description>plasma free T3 level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline plasma free T4 level</measure>
    <time_frame>1, 3, 5, 7, 30, 90, 180, 360 days post-op</time_frame>
    <description>plasma free T4 level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine output</measure>
    <time_frame>Daily post-op,for the duration of hospital stay, an expected average of 7 days</time_frame>
    <description>24-hour urine output</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pituitary Neoplasms</condition>
  <condition>Craniopharyngiomas</condition>
  <arm_group>
    <arm_group_label>A. Normal function, non-GC replacement</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No glucocorticoid replacement will be given perioperatively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B. Normal function, low-dose GC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1. 80mg hydrocortisone at day 2; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet at day 4 and day 5; 2.5mg at day 6;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C. Impaired function, low-dose GC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1. 80mg hydrocortisone at day 2; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet at day 4 and day 5; 2.5mg at day 6;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D. Impaired function, high-dose GC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1 and day 2. 60mg hydrocortisone at day 3; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet per day, since postoperative day 3.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrocortisone</intervention_name>
    <description>used intravenously</description>
    <arm_group_label>B. Normal function, low-dose GC</arm_group_label>
    <arm_group_label>C. Impaired function, low-dose GC</arm_group_label>
    <arm_group_label>D. Impaired function, high-dose GC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>used as tablet form</description>
    <arm_group_label>B. Normal function, low-dose GC</arm_group_label>
    <arm_group_label>C. Impaired function, low-dose GC</arm_group_label>
    <arm_group_label>D. Impaired function, high-dose GC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;= 18&#xD;
&#xD;
          -  Surgical patients with MRI-confirmed diagnosis of sellar lesions (non-functioning&#xD;
             pituitary adenoma or craniopharyngioma)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with pre-existing hyperthyroidism or Cushing's syndrome&#xD;
&#xD;
          -  Patients with long-term glucocorticoids replacement history&#xD;
&#xD;
          -  Patients with other co-morbidities that pose known influence upon the HPA-axis&#xD;
             function (cardiovascular or cerebrovascular disease, metabolic disease or epilepsy)&#xD;
&#xD;
          -  Patients with severe panhypopituitarism&#xD;
&#xD;
          -  Patients with history of radiotherapy of the pituitary gland&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shu Jiang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>West China Hospital, Sichuan University, Chengdu, Sichuan, PR China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Senlin Yin, M.D.</last_name>
    <phone>+86 13072808795</phone>
    <email>enforest@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Senlin Yin, M.D.</last_name>
      <phone>+86 13072808795</phone>
      <email>enforest@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Shu Jiang, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Senlin Yin, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Peizhi Zhou, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 5, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 11, 2014</last_update_submitted>
  <last_update_submitted_qc>July 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West China Hospital</investigator_affiliation>
    <investigator_full_name>Shu Jiang</investigator_full_name>
    <investigator_title>Professor Shu Jiang</investigator_title>
  </responsible_party>
  <keyword>Hydrocortisone</keyword>
  <keyword>Pituitary adenomas</keyword>
  <keyword>Replacement therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Craniopharyngioma</mesh_term>
    <mesh_term>Adamantinoma</mesh_term>
    <mesh_term>Pituitary Neoplasms</mesh_term>
    <mesh_term>Pituitary Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Hydrocortisone</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/NCT02190994
org study id: WestChina-2013137
nct id: NCT02190994
lead sponsor: 
has dmc: No
The purpose of this four-arm randomized controlled study is to determine whether eliminating
      glucocorticoids (GC) replacement in perioperative period in surgical patients with sellar
      lesion could result in similar or better outcomes comparing to traditional replacement
      therapy, regarding postoperative recovery of pituitary function and other postoperative
      complications (infection, pain, quality of life, recurrence). Surgical patients of our center
      with MRI-confirmed diagnosis of sellar lesion will be enrolled, insulin tolerance test (ITT)
      will be performed for assessment of the pituitary function at enrollment. Patients with
      normal pituitary function will be randomized into non-GC replacement group (group A) and
      low-dose GC replacement group (group B), while patients with impaired pituitary function will
      be randomized into low-dose GC replacement group (group C) and high-dose GC replacement group
      (group D). The primary outcome is the hypothalamic-pituitary-adrenal (HPA) -axis function of
      the patients, evaluated by plasma cortisol and adrenocorticotropic hormone (ACTH) levels. The
      secondary outcomes include the hypothalamic-pituitary-thyroid (HPT) axis function (TSH,
      thyroid-stimulating hormone, free T3, free T4), postoperative water-electrolyte balance,
      infection, recurrence and health-related quality of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from baseline plasma cortisol level
time frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
description: Plasma cortisol at 8:00, 16:00, 24:00 respectively
measure: Change from baseline plasma ACTH level
time frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
description: ACTH at 8:00;
measure: Change from baseline 24-hour urine free cortisol
time frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
description: 24-hour urine free cortisol
measure: Change from baseline insulin tolerance test result
time frame: 7, 30, 90 days post-op
description: insulin tolerance test result
measure: Change from baseline plasma TSH level
time frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
description: plasma TSH level
measure: Sodium, potassium concentration in the blood and urine
time frame: Daily post-op,for the duration of hospital stay, an expected average of 7 days
description: Concentration of sodium, potassium in the blood and urine
measure: Number of patients with postoperative infection
time frame: For the duration of hospital stay, an expected average of 7 days
description: Routine blood test, body temperature fluctuation, cerebrospinal fluid test if necessary.
measure: Change from baseline health-related quality of life
time frame: 7, 30, 90 days post-op
description: The 15-Dimensions measure of health-related quality of life
measure: Number of patients with recurred tumor
time frame: 3,6,12 months after surgery
description: Enhanced MRI scan of the sellar region.
measure: Change from baseline plasma free T3 level
time frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
description: plasma free T3 level
measure: Change from baseline plasma free T4 level
time frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
description: plasma free T4 level
measure: Urine output
time frame: Daily post-op,for the duration of hospital stay, an expected average of 7 days
description: 24-hour urine output
arm group label: A. Normal function, non-GC replacement
arm group type: No Intervention
description: No glucocorticoid replacement will be given perioperatively.
arm group label: B. Normal function, low-dose GC
arm group type: Active Comparator
description: Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1. 80mg hydrocortisone at day 2; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet at day 4 and day 5; 2.5mg at day 6;
arm group label: C. Impaired function, low-dose GC
arm group type: Active Comparator
description: Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1. 80mg hydrocortisone at day 2; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet at day 4 and day 5; 2.5mg at day 6;
arm group label: D. Impaired function, high-dose GC
arm group type: Active Comparator
description: Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1 and day 2. 60mg hydrocortisone at day 3; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet per day, since postoperative day 3.
intervention type: Drug
intervention name: Hydrocortisone
description: used intravenously
arm group label: B. Normal function, low-dose GC
arm group label: C. Impaired function, low-dose GC
arm group label: D. Impaired function, high-dose GC
intervention type: Drug
intervention name: Prednisone
description: used as tablet form
arm group label: B. Normal function, low-dose GC
arm group label: C. Impaired function, low-dose GC
arm group label: D. Impaired function, high-dose GC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shu Jiang, M.D.
role: Principal Investigator
affiliation: West China Hospital, Sichuan University, Chengdu, Sichuan, PR China
last name: Senlin Yin, M.D.
phone: +86 13072808795
email: enforest@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: West China Hospital
investigator full name: Shu Jiang
investigator title: Professor Shu Jiang
mesh term: Craniopharyngioma
mesh term: Adamantinoma
mesh term: Pituitary Neoplasms
mesh term: Pituitary Diseases
mesh term: Prednisone
mesh term: Hydrocortisone