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

August 25, 2020 updated by: Dong-Xin Wang, Peking University First Hospital

Effects of Epidural Anesthesia-analgesia on Long-term Survival in Patients After Lung Cancer Surgery: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 4 years after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay in hospital after surgery.
Time Frame: Up to 30 days after surgery.
Length of stay in hospital after surgery.
Up to 30 days after surgery.
Rate of intensive care unit admission after surgery.
Time Frame: Up to 30 days after surgery.
Rate of intensive care unit admission after surgery.
Up to 30 days after surgery.
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.
Up to 30 days after surgery.
Duration of chest tube placement.
Time Frame: Up to 30 days after surgery.
Duration of chest tube placement.
Up to 30 days after surgery.
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.
Up to 30 days after surgery.
Overall survival rate after surgery.
Time Frame: Up to 4 year after surgery.
Time from surgery to all-cause death.
Up to 4 year after surgery.
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.
Up to 4 years after surgery.
Activity engagement in 1-year survivors.
Time Frame: At the end of the first year after surgery.
Activity engagement is assessed by estimating metabolic equivalents (METs; 1 MET = 3·5 ml/min/kg resting oxygen consumption) for activity in daily life.
At the end of the first year after surgery.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the first 3 days after surgery.
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.
Up to 4 years after surgery.
Overall survival in cancer patients.
Time Frame: Up to 4 years after surgery.
Time from surgery to all-cause death.
Up to 4 years after surgery.
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.
Up to 4 years after surgery.
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.
After resection of lung adenocarcinoma specimens
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.
Peripheral blood samples collected before induction, at the end of surgery and at 24 hours after surgery.
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.
At 3 months and 6 months after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2015

Primary Completion (Actual)

November 11, 2017

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

June 12, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimate)

June 15, 2016

Study Record Updates

Last Update Posted (Actual)

August 27, 2020

Last Update Submitted That Met QC Criteria

August 25, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013[653]
  • ChiCTR-TRC-14004136 (Registry Identifier: Chinese Clinical Trial Registry (www.chictr.org.cn))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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