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Epidural Anesthesia-analgesia and Long-term Survival After Lung Cancer Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02801409
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Dong-Xin Wang, Peking University First Hospital

Brief Summary:
Available studies suggest that regional anesthesia-analgesia may decrease the occurrence of recurrence/metastasis in patients after cancer surgery. However, evidences from prospective studies are still lacking. The purpose of this randomized controlled trial is to investigate the effect of epidural anesthesia-analgesia on recurrence-free survival in patients undergoing lung cancer surgery.

Condition or disease Intervention/treatment Phase
Lung Cancer Thoracic Surgery Anesthesia, Epidural Neoplasm Recurrence, Local Neoplasm Metastasis Drug: General anesthesia alone Drug: Combined epidural-general anesthesia Not Applicable

Detailed Description:

Lung cancer is increasing and is the leading cause of cancer death. Surgical resection is the mainstay of treatment for early stage non-small cell lung cancer. However, long-term survival after lung cancer surgery is far from optimal, and cancer recurrence or metastasis is the main reason leading to cancer death in these patients.

The development of cancer recurrence/metastasis largely depends on the balance between tumor-promoting factors and immune function of the body. Studies showed that surgical manipulation releases cancer cells into circulation; and stress response induced by surgery inhibits the cell-mediated immunity. In addition, volatile anesthetics and opioids may also aggravate immunosuppression and potentially worsen long-term outcome. On the other hand, regional anesthesia can blunt surgical stress and reduce anesthetic consumption. These effects may help to preserve immune function and reduce recurrence/metastasis. However, existing evidences are insufficient to draw conclusion in this topic.

The purpose of this randomized controlled trial is to test the hypothesize that regional anesthesia-analgesia may reduce recurrence/metastasis and improve long-term survival in patients after lung cancer surgery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Epidural Anesthesia-analgesia on Long-term Survival in Patients After Lung Cancer Surgery: A Randomized Controlled Trial
Actual Study Start Date : May 25, 2015
Actual Primary Completion Date : November 11, 2017
Actual Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: General anesthesia alone
General anesthesia is performed during surgery; patient-controlled intravenous analgesia is provided after surgery.
Drug: General anesthesia alone
General anesthesia is performed during surgery; patient-controlled intravenous analgesia is provided after surgery.

Experimental: Combined epidural-general anesthesia
Combined epidural-general anesthesia is performed during surgery; patient-controlled epidural analgesia is provided after surgery.
Drug: Combined epidural-general anesthesia
Combined epidural-general anesthesia is performed during surgery; patient-controlled epidural analgesia is provided after surgery.




Primary Outcome Measures :
  1. Recurrence-free survival after surgery. [ Time Frame: Up to 4 years after surgery. ]
    Time from surgery to the earliest date of recurrence/metastasis or death from any cause, whichever came first.


Secondary Outcome Measures :
  1. Rate of intensive care unit admission after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Rate of intensive care unit admission after surgery.

  2. Incidence of postoperative complications during hospital stay. [ Time Frame: Up to 30 days after surgery. ]
    Postoperative complications are defined as new-onset conditions that are harmful to patients' recovery and required therapeutic intervention, i.e., class II or higher on the Clavien-Dindo classification.

  3. Duration of chest tube placement. [ Time Frame: Up to 30 days after surgery. ]
    Duration of chest tube placement.

  4. Length of stay in hospital after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Length of stay in hospital after surgery.

  5. Rate of all-cause mortality during hospital stay after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Rate of all-cause mortality during hospital stay after surgery.

  6. Overall survival rate after surgery. [ Time Frame: Up to 4 year after surgery. ]
    Time from surgery to all-cause death.

  7. Cancer-specific survival after surgery. [ Time Frame: Up to 4 years after surgery. ]
    Time from surgery to cancer-specific death; deaths from other causes are censored at the time of death.

  8. Activity engagement in 1-year survivors. [ Time Frame: At the end of the first year after surgery. ]
    Activity engagement is measured with metabolic equivalents. Activity of >9 metabolic equivalents indicates full physical recovery.


Other Outcome Measures:
  1. Pain intensity after surgery. [ Time Frame: During the first 3 days after surgery. ]
    Assessed with the numeric rating score, an 11-point scale where 0 = no pain and 10 = the most severe pain.

  2. Recurrence-free survival in cancer patients. [ Time Frame: Up to 4 years after surgery. ]
    Time from surgery to the earliest date of recurrence/metastasis or death from any cause, whichever came first.

  3. Overall survival in cancer patients. [ Time Frame: Up to 4 years after surgery. ]
    Time from surgery to all-cause death.

  4. Cancer-specific survival in cancer patients. [ Time Frame: Up to 4 years after surgery. ]
    Time from surgery to cancer-specific death; deaths from other causes are censored at the time of death.

  5. Number of CD8+ and FOXP3+ T cells per mm2 tumor area (sub-study). [ Time Frame: After resection of lung adenocarcinoma specimens ]
    Immunohistochemical staining of CD8 and FOXP3 molecules in excised lung adenocarcinoma specimens. Performed in part of enrolled patients.

  6. Percentage of NK-cells and T-cell subgroups in peripheral blood (sub-study). [ Time Frame: Peripheral blood samples collected before induction, at the end of surgery and at 24 hours after surgery. ]
    Measured by flow cytometry. Performed in part of enrolled patients.

  7. Rate of chronic pain at 3 month and 6 month after surgery (sub-study). [ Time Frame: At 3 months and 6 months after surgery. ]
    Chronic pain is measured with the Brief Pain Inventory (BPI), neuropathic pain screening questionnaire (ID pain), and McGill Pain Questionnair (MPQ). Performed in part of enrolled patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients (aged 18-80 years);
  2. Clinically diagnosed as primary non-small cell lung cancer of stage IA to IIIA, and scheduled for radical surgery;
  3. Agreed to receive patient-controlled analgesia after surgery.

Exclusion Criteria:

  1. Distant metastasis, malignant tumor in other organs, or chemo-/radiotherapy or other anti-cancer therapy before surgery;
  2. Comorbid with autoimmune diseases, or glucocorticoid/immunosuppressant therapy within 1 year;
  3. History of schizophrenia, epilepsy or Parkinson disease, or unable to complete preoperative assessment due to severe dementia, language barrier, or end-stage disease;
  4. Severe hepatic disease (Child-Pugh classification C), renal failure (serum creatinine >442 umol/L or receiving renal replacement therapy), or American Society of Anesthesiologists classification IV or higher;
  5. History of anesthesia and/or surgery within 1 year;
  6. Contraindications to epidural anesthesia, including spinal deformity, coagulation dysfunction, local infection, and history of spinal trauma/surgery;
  7. Allergic to any medications used during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801409


Locations
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China, Beijing
Peking University First Hospital
Beijing, Beijing, China, 100034
Sponsors and Collaborators
Peking University First Hospital
Investigators
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Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital
Publications:

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Responsible Party: Dong-Xin Wang, Professor, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT02801409    
Other Study ID Numbers: 2013[653]
ChiCTR-TRC-14004136 ( Registry Identifier: Chinese Clinical Trial Registry (www.chictr.org.cn) )
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dong-Xin Wang, Peking University First Hospital:
Lung Cancer
Surgical Resection
Epidural Anesthesia and Analgesia
Cancer recurrence/metastasis
Long-Term Outcome
Additional relevant MeSH terms:
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Lung Neoplasms
Neoplasm Metastasis
Neoplasm Recurrence, Local
Recurrence
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Disease Attributes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs