<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/NCT03245346</url>
  </required_header>
  <id_info>
    <org_study_id>FDUSCCA-1</org_study_id>
    <nct_id>NCT03245346</nct_id>
  </id_info>
  <brief_title>Effects of Epidural Anesthesia and Analgesia on the Prognosis in Patients Undergoing Pancreatic Cancer Surgery</brief_title>
  <official_title>Effects of Epidural Anesthesia and Analgesia on the Prognosis in Patients Undergoing Pancreatic Cancer Surgery: A Multi-center Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this randomized controlled trial is to investigate the effects of epidural&#xD;
      anesthesia and analgesia on the overall survival，disease-free survival and recovery in&#xD;
      patients undergoing pancreatic cancer surgery. This study will also evaluate the effects of&#xD;
      this technique on neuroendocrine, stress and inflammatory response in these patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 19, 2017</start_date>
  <completion_date type="Anticipated">December 18, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 18, 2021</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>During 2 years after surgery</time_frame>
    <description>Defined and calculated as the time from the date of surgery to death related to all reasons</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival (DFS )</measure>
    <time_frame>During 2 years after surgery</time_frame>
    <description>Defined and calculated as the time from the date of surgery to the first time of pancreatic cancer recurrence or metastasis or cancer-related death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain score and side effects of patient-controlled analgesia</measure>
    <time_frame>During the first 48 hours after surgery</time_frame>
    <description>Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of delirium</measure>
    <time_frame>During the first 1 week after surgery</time_frame>
    <description>Assessed for delirium using the 3D-CAM instrument</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of persistent post-surgical pain (PPSP) after surgery</measure>
    <time_frame>During 2 years after surgery</time_frame>
    <description>Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in hospital after surgery and total costs after surgery</measure>
    <time_frame>During the first 30 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return of bowel function</measure>
    <time_frame>During the first 30 days after surgery</time_frame>
    <description>Measured by the time of first flatus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Start of enteral tube feeding</measure>
    <time_frame>During the first 30 days after surgery</time_frame>
    <description>Measured by the time of first enteral tube feeding after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Removal of Perianastomotic drains</measure>
    <time_frame>During the first 30 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Removal of Urinary drainage</measure>
    <time_frame>During the first 30 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Removal of nasogastric tube</measure>
    <time_frame>During the first 30 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Removal of enteral feeding tube</measure>
    <time_frame>During the first 30 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood level of neuroendocrine, stress and inflammatory response</measure>
    <time_frame>During surgery and the first 24 hours after surgery (post-operative day 1)</time_frame>
    <description>Changes of blood epinephrine, norepinephrine, cortisol, VEGF, interleukin-6 (IL-6)、interleukin-8 (IL-8), peripheral blood NLR ( neutrophil-lymphocyte ratio)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum CA19-9 、CA125、CEA、CA72-4、CA242、AFP、CA15-3、CA50 levels</measure>
    <time_frame>During 2 years after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma levels of ropivacaine and sufentanil</measure>
    <time_frame>During surgery and the first 24 hours after surgery (post-operative day 1)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">540</enrollment>
  <condition>Cancer of Pancreas</condition>
  <arm_group>
    <arm_group_label>GEA+PCEA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>General anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GA+PCIA</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GEA</intervention_name>
    <description>Thoracic epidural catheterization will be performed and epidural anesthesia will be maintained with 0.25% ropivacaine during surgery. General anesthesia will be maintained with inhalation (sevoflurane) and muscle relaxants will be administered when considered necessary.</description>
    <arm_group_label>GEA+PCEA</arm_group_label>
    <other_name>General anesthesia combined with epidural anesthesia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PCEA</intervention_name>
    <description>Patient-controlled epidural analgesia (0.15% ropivacaine infusion) will be provided after surgery.</description>
    <arm_group_label>GEA+PCEA</arm_group_label>
    <other_name>Patient-controlled epidural analgesia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GA</intervention_name>
    <description>General anesthesia will be maintained with inhalation (sevoflurane) and sufentanil infusion, and muscle relaxants will be administered when considered necessary.</description>
    <arm_group_label>GA+PCIA</arm_group_label>
    <other_name>General anesthesia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PCIA</intervention_name>
    <description>Patient-controlled intravenous analgesia (1ug/ml sufentanil) will be provided after surgery.</description>
    <arm_group_label>GA+PCIA</arm_group_label>
    <other_name>Patient-controlled intravenous analgesia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Undergoing elective pancreaticoduodenectomy for pancreatic cancer .&#xD;
&#xD;
          2. ASA statusⅠ-Ⅲ.&#xD;
&#xD;
          3. 18 years to 80 years （adults）.&#xD;
&#xD;
          4. Able to understand, communicate and sign an informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Laparoscopic surgery.&#xD;
&#xD;
          2. Preoperative chemotherapy or radiotherapy.&#xD;
&#xD;
          3. Pregnancy.&#xD;
&#xD;
          4. Allergic to any drugs used during the study.&#xD;
&#xD;
          5. Long-term receiving β-blockers.&#xD;
&#xD;
          6. Complicated with chronic inflammatory diseases, autoimmune diseases, or long-term&#xD;
             receiving glucocorticoids or other immunosuppressants before surgery.&#xD;
&#xD;
          7. Abnormal coagulation functions (platelet count prior to surgery &lt;100000/ μL , APTT&#xD;
             value is more than the normal value, INR &gt; 1.3 or clopidogrel that cannot be&#xD;
             discontinued 7 days prior to surgery).&#xD;
&#xD;
          8. Complicated with severe heart disease (NYHA classification &gt;3), severe renal&#xD;
             insufficiency (serum creatinine &gt;1.8mg/dL or receiving renal replacement therapy),&#xD;
             severe hepatic disease (Child-Pugh classification&#xD;
&#xD;
             = C), diabetes (fasting blood glucose not in the range of 3.9-13.8 mmol/L ), or acute&#xD;
             infectious diseases (WBC&gt;10000/μL) before surgery.&#xD;
&#xD;
          9. BMI &gt; 35.&#xD;
&#xD;
         10. All contraindications to epidural anesthesia and analgesia.&#xD;
&#xD;
         11. Chronic opiate medication/drug abuse.&#xD;
&#xD;
         12. Complicated with severe mental illness, cognitive disorder or unable to collaborate&#xD;
             during the study.&#xD;
&#xD;
         13. Refuse to sign an informed consent form.&#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>Changhong Miao</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Qianjin Liu</last_name>
    <role>Study Director</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Changhong Miao</last_name>
    <phone>+86-021-64175590</phone>
    <email>miaochh@aliyun.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xuqin Zhu</last_name>
    <phone>+86-021-64175590</phone>
    <email>zhuxuqin1101@sina.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Changhao Miao</last_name>
      <phone>+86-021-64175590</phone>
      <email>miaochh@aliyun.com</email>
    </contact>
    <contact_backup>
      <last_name>Xuqin Zhu</last_name>
      <phone>+86-021-64175590</phone>
      <email>zhuxuqin1101@sina.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Fudan University Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jing Cang</last_name>
      <phone>+86-139-1601-0421</phone>
      <email>cangjing1998@aliyun.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fudan University Huashan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yingwei Wang</last_name>
      <phone>+86-139-1869-0528</phone>
      <email>wangyingwei@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>December 9, 2019</last_update_submitted>
  <last_update_submitted_qc>December 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Changhong Miao</investigator_full_name>
    <investigator_title>Director of Anesthesiology Department of Fudan University Shanghai Cancer Center</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</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/NCT03245346
org study id: FDUSCCA-1
nct id: NCT03245346
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this randomized controlled trial is to investigate the effects of epidural
      anesthesia and analgesia on the overall survival，disease-free survival and recovery in
      patients undergoing pancreatic cancer surgery. This study will also evaluate the effects of
      this technique on neuroendocrine, stress and inflammatory response in these patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Overall survival (OS)
time frame: During 2 years after surgery
description: Defined and calculated as the time from the date of surgery to death related to all reasons
measure: Disease-free survival (DFS )
time frame: During 2 years after surgery
description: Defined and calculated as the time from the date of surgery to the first time of pancreatic cancer recurrence or metastasis or cancer-related death
measure: Postoperative pain score and side effects of patient-controlled analgesia
time frame: During the first 48 hours after surgery
description: Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)
measure: Incidence of delirium
time frame: During the first 1 week after surgery
description: Assessed for delirium using the 3D-CAM instrument
measure: Incidence of persistent post-surgical pain (PPSP) after surgery
time frame: During 2 years after surgery
description: Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)
measure: Length of stay in hospital after surgery and total costs after surgery
time frame: During the first 30 days after surgery
measure: Return of bowel function
time frame: During the first 30 days after surgery
description: Measured by the time of first flatus
measure: Start of enteral tube feeding
time frame: During the first 30 days after surgery
description: Measured by the time of first enteral tube feeding after surgery
measure: Removal of Perianastomotic drains
time frame: During the first 30 days after surgery
measure: Removal of Urinary drainage
time frame: During the first 30 days after surgery
measure: Removal of nasogastric tube
time frame: During the first 30 days after surgery
measure: Removal of enteral feeding tube
time frame: During the first 30 days after surgery
measure: Blood level of neuroendocrine, stress and inflammatory response
time frame: During surgery and the first 24 hours after surgery (post-operative day 1)
description: Changes of blood epinephrine, norepinephrine, cortisol, VEGF, interleukin-6 (IL-6)、interleukin-8 (IL-8), peripheral blood NLR ( neutrophil-lymphocyte ratio)
measure: Serum CA19-9 、CA125、CEA、CA72-4、CA242、AFP、CA15-3、CA50 levels
time frame: During 2 years after surgery
measure: Plasma levels of ropivacaine and sufentanil
time frame: During surgery and the first 24 hours after surgery (post-operative day 1)
arm group label: GEA+PCEA
arm group type: Experimental
description: General anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery.
arm group label: GA+PCIA
arm group type: Other
description: General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery.
intervention type: Drug
intervention name: GEA
description: Thoracic epidural catheterization will be performed and epidural anesthesia will be maintained with 0.25% ropivacaine during surgery. General anesthesia will be maintained with inhalation (sevoflurane) and muscle relaxants will be administered when considered necessary.
arm group label: GEA+PCEA
other name: General anesthesia combined with epidural anesthesia
intervention type: Drug
intervention name: PCEA
description: Patient-controlled epidural analgesia (0.15% ropivacaine infusion) will be provided after surgery.
arm group label: GEA+PCEA
other name: Patient-controlled epidural analgesia
intervention type: Drug
intervention name: GA
description: General anesthesia will be maintained with inhalation (sevoflurane) and sufentanil infusion, and muscle relaxants will be administered when considered necessary.
arm group label: GA+PCIA
other name: General anesthesia
intervention type: Drug
intervention name: PCIA
description: Patient-controlled intravenous analgesia (1ug/ml sufentanil) will be provided after surgery.
arm group label: GA+PCIA
other name: Patient-controlled intravenous analgesia
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Changhong Miao
role: Principal Investigator
affiliation: Fudan University
last name: Qianjin Liu
role: Study Director
affiliation: Washington University School of Medicine
last name: Changhong Miao
phone: +86-021-64175590
email: miaochh@aliyun.com
last name: Xuqin Zhu
phone: +86-021-64175590
email: zhuxuqin1101@sina.com
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Changhong Miao
investigator title: Director of Anesthesiology Department of Fudan University Shanghai Cancer Center
mesh term: Pancreatic Neoplasms
mesh term: Anesthetics