<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/NCT03012945</url>
  </required_header>
  <id_info>
    <org_study_id>PUCRP201101-1</org_study_id>
    <nct_id>NCT03012945</nct_id>
  </id_info>
  <brief_title>Epidural Anesthesia-analgesia and Long-term Outcome</brief_title>
  <official_title>Impact of Epidural Anesthesia-analgesia on Long-term Outcome in Elderly Patients After Surgery: 5-year Follow-up of a Multicenter Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Shijitan Hospital, Capital Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University First 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>
      Surgical resection is one of the most important treatments for resectable cancer; on the&#xD;
      other hand, cancer recurrence and/or metastasis are the major reasons of treatment failure.&#xD;
      The development of recurrence/metastasis after cancer surgery mostly depends on the balance&#xD;
      between the immunity of human body and the capability of implantation, proliferation and&#xD;
      neovascularization of the residual cancer. Preclinical and retrospective clinical studies&#xD;
      suggest that anaesthetic management may affect the long-term outcomes after cancer surgery.&#xD;
      The investigators hypothesize that use of epidural anesthesia-analgesia may improve long-term&#xD;
      survival in elderly patients after major surgery for cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgical resection is the main treatment for potentially curable solid organ cancer. However,&#xD;
      it is unavoidable that some cancer cells are disseminated into the circulatory or lymphatic&#xD;
      system during surgery. And quite a number of patients develop cancer recurrence and/or&#xD;
      metastasis after surgery, which are associated with poor long-term outcomes. The development&#xD;
      of cancer recurrence and/or metastasis after surgery is mostly dependent on the balance&#xD;
      between the anti-tumor immune function of the human body and the ability of implantation,&#xD;
      proliferation and neovascularization of the residual cancer cells.&#xD;
&#xD;
      Multiple surgical factors may influence the balance between the anti-cancer immune function&#xD;
      and cancer recurrence. For example, the presence of the primary cancer inhibits angiogenesis,&#xD;
      whereas cancer resection eliminates this safeguard against angiogenesis; surgical&#xD;
      manipulation releases cancer cells into the circulation; surgery-related stress response&#xD;
      inhibits natural killer (NK) cell activity and can promote the development of cancer&#xD;
      metastasis; local and systemic release of growth factors during surgery may also promote&#xD;
      cancer recurrence both locally and at distant sites.&#xD;
&#xD;
      Available studies showed that general anaesthesia/anesthetics may influence the cellular&#xD;
      immune function and long-term outcomes. For example, it was found that ketamine and&#xD;
      thiopental, but not propofol, suppressed NK cell activity; all three drugs caused a&#xD;
      significant reduction in NK cell number; isoflurane and halothane inhibit interferon (IFN)&#xD;
      stimulation of NK cell cytotoxicity; nitrous oxide interferes with DNA, purine, and&#xD;
      thymidylate synthesis and depresses neutrophil chemotaxis; opioids have been reported to&#xD;
      suppress cell-mediated and humoral immunity.&#xD;
&#xD;
      Considering the potential harmful effects of general anesthesia/anesthetics, there is an&#xD;
      increasing interest on the effect of regional anaesthesia. Retrospective studies&#xD;
      investigating the relationship between epidural anesthesia and outcome after cancer surgery&#xD;
      gave different results. In a meta-analysis, regional anesthesia is associated with improved&#xD;
      survival (hazard ratio [HR] 0.84, 95% confidence interval [CI] 0.74-0.96, P = 0.013), but not&#xD;
      cancer recurrence/metastasis (HR 0.88, 95% Cl 0.64-1.22, P = 0.457). The investigators&#xD;
      hypothesize that combined use of epidural anesthesia may produce favorable effects on the&#xD;
      long-term survival in elderly patients undergoing major cancer surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2014</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival after surgery.</measure>
    <time_frame>Up to median 5 years after surgery.</time_frame>
    <description>Time from surgery to the date of all-cause death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cancer-specific survival after surgery.</measure>
    <time_frame>Up to median 5 years after surgery.</time_frame>
    <description>Time from surgery to the date of cancer-specific death. Patients who die from other causes will be censored at the time of death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence-free survival after surgery.</measure>
    <time_frame>Up to median 5 years after surgery.</time_frame>
    <description>Time from surgery to the date of cancer recurrence/metastasis or all-cause death, whichever come first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-free survival after surgery.</measure>
    <time_frame>Up to median 5 years after surgery.</time_frame>
    <description>Time from surgery to the first date of cancer recurrence/metastasis, new onset cancer, new serious non-cancer disease, or death from any cause.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Overall survival after surgery (cancer patients).</measure>
    <time_frame>Up to median 5 years after surgery.</time_frame>
    <description>Time from surgery to the date of all-cause death.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cancer-specific survival after surgery (cancer patients).</measure>
    <time_frame>Up to median 5 years after surgery.</time_frame>
    <description>Time from surgery to the date of cancer-specific death. Patients who die from other causes will be censored at the time of death.</description>
  </other_outcome>
  <other_outcome>
    <measure>Recurrence-free survival after surgery (cancer patients).</measure>
    <time_frame>Up to median 5 years after surgery.</time_frame>
    <description>Time from surgery to the date of cancer recurrence/metastasis or all-cause death, whichever come first.</description>
  </other_outcome>
  <other_outcome>
    <measure>Event-free survival after surgery (cancer patients).</measure>
    <time_frame>Up to median 5 years after surgery.</time_frame>
    <description>Time from surgery to the first date of cancer recurrence/metastasis, new onset cancer, new serious non-cancer disease, or death from any cause.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cognitive function (3-year survivors).</measure>
    <time_frame>At the end of the 3rd year after surgery.</time_frame>
    <description>Cognitive function is assessed with the modified Telephone Interview for Cognitive Status (TICS-m; a 12-item questionnaire that assesses global cognitive function by verbal communication via telephone. The score ranges from 0 to 50, with higher score indicating better function).</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life (3-year survivors).</measure>
    <time_frame>At the end of the 3rd year after surgery.</time_frame>
    <description>Quality of life is assessed with the World Health Organization Quality of Life-brief version (WHOQOL-BREF; a 24-item questionnaire that assesses the quality of life in physical, psychological, social relationship and environmental domains. The score ranges from 0 to 100 for each domain, with higher score indicating better function).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1802</enrollment>
  <condition>Elderly</condition>
  <condition>Malignant Tumor</condition>
  <condition>Surgical Resection</condition>
  <condition>Epidural Anesthesia</condition>
  <condition>Long-term Outcome</condition>
  <arm_group>
    <arm_group_label>Combined epidural-general anesthesia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients assigned to this group (experimental group) receive combined epidural-general anesthesia and postoperative patient-controlled epidural analgesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>General anesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients assigned to this group (control group) receive general anesthesia and postoperative patient-controlled intravenous analgesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Combined epidural-general anesthesia</intervention_name>
    <description>Combined epidural-general anesthesia and postoperative epidural analgesia. General anesthesia is performed as that in the general anesthesia group. Epidural anesthesia is performed with ropivacaine. Epidural analgesia is performed with a mixture of ropivacaine and sufentanil.</description>
    <arm_group_label>Combined epidural-general anesthesia</arm_group_label>
    <other_name>Combined epidural-general anesthesia and postoperative epidural analgesia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>General anesthesia</intervention_name>
    <description>General anesthesia and postoperative intravenous analgesia. General anesthesia is performed with propofol induction and propofol and/or sevoflurane maintenance. Intravenous analgesia is performed with morphine.</description>
    <arm_group_label>General anesthesia</arm_group_label>
    <other_name>General anesthesia and postoperative intravenous analgesia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elderly patients (age 60-90 years);&#xD;
&#xD;
          -  Scheduled to undergo noncardiac thoracic or abdominal surgery with an expected&#xD;
             duration of 2 hours or longer. For those who undergo thoracoscopic or laparoscopic&#xD;
             surgery, the expected length of incision must be 5 centimeters or more;&#xD;
&#xD;
          -  Agree to receive patient-controlled postoperative analgesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refuse to participate;&#xD;
&#xD;
          -  Previous history of schizophrenia, epilepsy or Parkinson disease, or unable to&#xD;
             complete preoperative assessment due to severe dementia, language barrier or end-stage&#xD;
             disease;&#xD;
&#xD;
          -  History of myocardial infarction or stroke within 3 months before surgery;&#xD;
&#xD;
          -  Presence of any contraindication to epidural anesthesia and analgesia, including&#xD;
             abnormal vertebral anatomy, previous spinal trauma or surgery, severe chronic back&#xD;
             pain, coagulation disorder (prothrombin time or activated partial prothrombin time&#xD;
             longer than 1.5 times of the upper normal limit, or platelet count of less than 80 *&#xD;
             10^9/L), local infection near the site of puncture, and severe sepsis;&#xD;
&#xD;
          -  Severe heart dysfunction (New York Heart Association functional classification 3 or&#xD;
             above), severe hepatic insufficiency (Child-Pugh grade C), or severe renal&#xD;
             insufficiency (serum creatinine of 442 umol/L or above, with or without serum&#xD;
             potassium of 6.5 mmol/L or above, or requirement of renal replacement therapy);&#xD;
&#xD;
          -  Any other conditions that are considered unsuitable for study participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dong-Xin Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University First Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Shijitan Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University People's Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Yamaguchi K, Takagi Y, Aoki S, Futamura M, Saji S. Significant detection of circulating cancer cells in the blood by reverse transcriptase-polymerase chain reaction during colorectal cancer resection. Ann Surg. 2000 Jul;232(1):58-65. doi: 10.1097/00000658-200007000-00009.</citation>
    <PMID>10862196</PMID>
  </reference>
  <reference>
    <citation>Shakhar G, Ben-Eliyahu S. Potential prophylactic measures against postoperative immunosuppression: could they reduce recurrence rates in oncological patients? Ann Surg Oncol. 2003 Oct;10(8):972-92. doi: 10.1245/aso.2003.02.007.</citation>
    <PMID>14527919</PMID>
  </reference>
  <reference>
    <citation>Sessler DI. Long-term consequences of anesthetic management. Anesthesiology. 2009 Jul;111(1):1-4. doi: 10.1097/ALN.0b013e3181a913e1. No abstract available.</citation>
    <PMID>19512884</PMID>
  </reference>
  <reference>
    <citation>Buggy DJ, Smith G. Epidural anaesthesia and analgesia: better outcome after major surgery?. Growing evidence suggests so. BMJ. 1999 Aug 28;319(7209):530-1. doi: 10.1136/bmj.319.7209.530. No abstract available.</citation>
    <PMID>10463878</PMID>
  </reference>
  <reference>
    <citation>Melamed R, Bar-Yosef S, Shakhar G, Shakhar K, Ben-Eliyahu S. Suppression of natural killer cell activity and promotion of tumor metastasis by ketamine, thiopental, and halothane, but not by propofol: mediating mechanisms and prophylactic measures. Anesth Analg. 2003 Nov;97(5):1331-1339. doi: 10.1213/01.ANE.0000082995.44040.07.</citation>
    <PMID>14570648</PMID>
  </reference>
  <reference>
    <citation>Mitsuhata H, Shimizu R, Yokoyama MM. Suppressive effects of volatile anesthetics on cytokine release in human peripheral blood mononuclear cells. Int J Immunopharmacol. 1995 Jun;17(6):529-34. doi: 10.1016/0192-0561(95)00026-x.</citation>
    <PMID>7499031</PMID>
  </reference>
  <reference>
    <citation>Markovic SN, Knight PR, Murasko DM. Inhibition of interferon stimulation of natural killer cell activity in mice anesthetized with halothane or isoflurane. Anesthesiology. 1993 Apr;78(4):700-6. doi: 10.1097/00000542-199304000-00013.</citation>
    <PMID>8466070</PMID>
  </reference>
  <reference>
    <citation>Gupta K, Kshirsagar S, Chang L, Schwartz R, Law PY, Yee D, Hebbel RP. Morphine stimulates angiogenesis by activating proangiogenic and survival-promoting signaling and promotes breast tumor growth. Cancer Res. 2002 Aug 1;62(15):4491-8.</citation>
    <PMID>12154060</PMID>
  </reference>
  <reference>
    <citation>Beilin B, Martin FC, Shavit Y, Gale RP, Liebeskind JC. Suppression of natural killer cell activity by high-dose narcotic anesthesia in rats. Brain Behav Immun. 1989 Jun;3(2):129-37. doi: 10.1016/0889-1591(89)90013-5.</citation>
    <PMID>2477090</PMID>
  </reference>
  <reference>
    <citation>Gaspani L, Bianchi M, Limiroli E, Panerai AE, Sacerdote P. The analgesic drug tramadol prevents the effect of surgery on natural killer cell activity and metastatic colonization in rats. J Neuroimmunol. 2002 Aug;129(1-2):18-24. doi: 10.1016/s0165-5728(02)00165-0.</citation>
    <PMID>12161016</PMID>
  </reference>
  <reference>
    <citation>O'Riain SC, Buggy DJ, Kerin MJ, Watson RWG, Moriarty DC. Inhibition of the stress response to breast cancer surgery by regional anesthesia and analgesia does not affect vascular endothelial growth factor and prostaglandin E2. Anesth Analg. 2005 Jan;100(1):244-249. doi: 10.1213/01.ANE.0000143336.37946.7D.</citation>
    <PMID>15616085</PMID>
  </reference>
  <reference>
    <citation>Chen WK, Miao CH. The effect of anesthetic technique on survival in human cancers: a meta-analysis of retrospective and prospective studies. PLoS One. 2013;8(2):e56540. doi: 10.1371/journal.pone.0056540. Epub 2013 Feb 20.</citation>
    <PMID>23437162</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 31, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>July 6, 2020</last_update_submitted>
  <last_update_submitted_qc>July 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Dong-Xin Wang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Elderly</keyword>
  <keyword>Cancer surgery</keyword>
  <keyword>Epidural anesthesia and analgesia</keyword>
  <keyword>Long-term survival</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be provided on request.</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/NCT03012945
org study id: PUCRP201101-1
nct id: NCT03012945
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Surgical resection is one of the most important treatments for resectable cancer; on the
      other hand, cancer recurrence and/or metastasis are the major reasons of treatment failure.
      The development of recurrence/metastasis after cancer surgery mostly depends on the balance
      between the immunity of human body and the capability of implantation, proliferation and
      neovascularization of the residual cancer. Preclinical and retrospective clinical studies
      suggest that anaesthetic management may affect the long-term outcomes after cancer surgery.
      The investigators hypothesize that use of epidural anesthesia-analgesia may improve long-term
      survival in elderly patients after major surgery for cancer.
Surgical resection is the main treatment for potentially curable solid organ cancer. However,
      it is unavoidable that some cancer cells are disseminated into the circulatory or lymphatic
      system during surgery. And quite a number of patients develop cancer recurrence and/or
      metastasis after surgery, which are associated with poor long-term outcomes. The development
      of cancer recurrence and/or metastasis after surgery is mostly dependent on the balance
      between the anti-tumor immune function of the human body and the ability of implantation,
      proliferation and neovascularization of the residual cancer cells.

      Multiple surgical factors may influence the balance between the anti-cancer immune function
      and cancer recurrence. For example, the presence of the primary cancer inhibits angiogenesis,
      whereas cancer resection eliminates this safeguard against angiogenesis; surgical
      manipulation releases cancer cells into the circulation; surgery-related stress response
      inhibits natural killer (NK) cell activity and can promote the development of cancer
      metastasis; local and systemic release of growth factors during surgery may also promote
      cancer recurrence both locally and at distant sites.

      Available studies showed that general anaesthesia/anesthetics may influence the cellular
      immune function and long-term outcomes. For example, it was found that ketamine and
      thiopental, but not propofol, suppressed NK cell activity; all three drugs caused a
      significant reduction in NK cell number; isoflurane and halothane inhibit interferon (IFN)
      stimulation of NK cell cytotoxicity; nitrous oxide interferes with DNA, purine, and
      thymidylate synthesis and depresses neutrophil chemotaxis; opioids have been reported to
      suppress cell-mediated and humoral immunity.

      Considering the potential harmful effects of general anesthesia/anesthetics, there is an
      increasing interest on the effect of regional anaesthesia. Retrospective studies
      investigating the relationship between epidural anesthesia and outcome after cancer surgery
      gave different results. In a meta-analysis, regional anesthesia is associated with improved
      survival (hazard ratio [HR] 0.84, 95% confidence interval [CI] 0.74-0.96, P = 0.013), but not
      cancer recurrence/metastasis (HR 0.88, 95% Cl 0.64-1.22, P = 0.457). The investigators
      hypothesize that combined use of epidural anesthesia may produce favorable effects on the
      long-term survival in elderly patients undergoing major cancer surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Overall survival after surgery.
time frame: Up to median 5 years after surgery.
description: Time from surgery to the date of all-cause death.
measure: Cancer-specific survival after surgery.
time frame: Up to median 5 years after surgery.
description: Time from surgery to the date of cancer-specific death. Patients who die from other causes will be censored at the time of death.
measure: Recurrence-free survival after surgery.
time frame: Up to median 5 years after surgery.
description: Time from surgery to the date of cancer recurrence/metastasis or all-cause death, whichever come first.
measure: Event-free survival after surgery.
time frame: Up to median 5 years after surgery.
description: Time from surgery to the first date of cancer recurrence/metastasis, new onset cancer, new serious non-cancer disease, or death from any cause.
measure: Overall survival after surgery (cancer patients).
time frame: Up to median 5 years after surgery.
description: Time from surgery to the date of all-cause death.
measure: Cancer-specific survival after surgery (cancer patients).
time frame: Up to median 5 years after surgery.
description: Time from surgery to the date of cancer-specific death. Patients who die from other causes will be censored at the time of death.
measure: Recurrence-free survival after surgery (cancer patients).
time frame: Up to median 5 years after surgery.
description: Time from surgery to the date of cancer recurrence/metastasis or all-cause death, whichever come first.
measure: Event-free survival after surgery (cancer patients).
time frame: Up to median 5 years after surgery.
description: Time from surgery to the first date of cancer recurrence/metastasis, new onset cancer, new serious non-cancer disease, or death from any cause.
measure: Cognitive function (3-year survivors).
time frame: At the end of the 3rd year after surgery.
description: Cognitive function is assessed with the modified Telephone Interview for Cognitive Status (TICS-m; a 12-item questionnaire that assesses global cognitive function by verbal communication via telephone. The score ranges from 0 to 50, with higher score indicating better function).
measure: Quality of life (3-year survivors).
time frame: At the end of the 3rd year after surgery.
description: Quality of life is assessed with the World Health Organization Quality of Life-brief version (WHOQOL-BREF; a 24-item questionnaire that assesses the quality of life in physical, psychological, social relationship and environmental domains. The score ranges from 0 to 100 for each domain, with higher score indicating better function).
arm group label: Combined epidural-general anesthesia
arm group type: Experimental
description: Patients assigned to this group (experimental group) receive combined epidural-general anesthesia and postoperative patient-controlled epidural analgesia.
arm group label: General anesthesia
arm group type: Active Comparator
description: Patients assigned to this group (control group) receive general anesthesia and postoperative patient-controlled intravenous analgesia.
intervention type: Drug
intervention name: Combined epidural-general anesthesia
description: Combined epidural-general anesthesia and postoperative epidural analgesia. General anesthesia is performed as that in the general anesthesia group. Epidural anesthesia is performed with ropivacaine. Epidural analgesia is performed with a mixture of ropivacaine and sufentanil.
arm group label: Combined epidural-general anesthesia
other name: Combined epidural-general anesthesia and postoperative epidural analgesia
intervention type: Drug
intervention name: General anesthesia
description: General anesthesia and postoperative intravenous analgesia. General anesthesia is performed with propofol induction and propofol and/or sevoflurane maintenance. Intravenous analgesia is performed with morphine.
arm group label: General anesthesia
other name: General anesthesia and postoperative intravenous analgesia
criteria: 
gender: All
minimum age: 60 Years
maximum age: 90 Years
healthy volunteers: No
last name: Dong-Xin Wang, MD
role: Principal Investigator
affiliation: Peking University First Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
citation: Yamaguchi K, Takagi Y, Aoki S, Futamura M, Saji S. Significant detection of circulating cancer cells in the blood by reverse transcriptase-polymerase chain reaction during colorectal cancer resection. Ann Surg. 2000 Jul;232(1):58-65. doi: 10.1097/00000658-200007000-00009.
PMID: 10862196
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responsible party type: Principal Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Dong-Xin Wang
investigator title: Professor
mesh term: Neoplasms
mesh term: Anesthetics
sharing ipd: No
ipd description: Data will be provided on request.