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

Primary Purpose

Lung Cancer, Thoracic Surgery, Anesthesia, Epidural

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
General anesthesia alone
Combined epidural-general anesthesia
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Cancer focused on measuring Lung Cancer, Surgical Resection, Epidural Anesthesia and Analgesia, Cancer recurrence/metastasis, Long-Term Outcome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

General anesthesia alone

Combined epidural-general anesthesia

Arm Description

General anesthesia is performed during surgery; patient-controlled intravenous analgesia is provided after surgery.

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

Outcomes

Primary Outcome Measures

Recurrence-free survival after surgery.
Time from surgery to the earliest date of recurrence/metastasis or death from any cause, whichever came first.

Secondary Outcome Measures

Rate of intensive care unit admission after surgery.
Rate of intensive care unit admission after surgery.
Incidence of postoperative complications during hospital stay.
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.
Duration of chest tube placement.
Duration of chest tube placement.
Length of stay in hospital after surgery.
Length of stay in hospital after surgery.
Rate of all-cause mortality during hospital stay after surgery.
Rate of all-cause mortality during hospital stay after surgery.
Overall survival rate after surgery.
Time from surgery to all-cause death.
Cancer-specific survival after surgery.
Time from surgery to cancer-specific death; deaths from other causes are censored at the time of death.
Activity engagement in 1-year survivors.
Activity engagement is assessed by estimating metabolic equivalents (METs; 1 MET = 3·5 ml/min/kg resting oxygen consumption) for activity in daily life.

Full Information

First Posted
June 12, 2016
Last Updated
August 25, 2020
Sponsor
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02801409
Brief Title
Epidural Anesthesia-analgesia and Long-term Survival After Lung Cancer Surgery
Official Title
Effects of Epidural Anesthesia-analgesia on Long-term Survival in Patients After Lung Cancer Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 25, 2015 (Actual)
Primary Completion Date
November 11, 2017 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Thoracic Surgery, Anesthesia, Epidural, Neoplasm Recurrence, Local, Neoplasm Metastasis
Keywords
Lung Cancer, Surgical Resection, Epidural Anesthesia and Analgesia, Cancer recurrence/metastasis, Long-Term Outcome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
General anesthesia alone
Arm Type
Active Comparator
Arm Description
General anesthesia is performed during surgery; patient-controlled intravenous analgesia is provided after surgery.
Arm Title
Combined epidural-general anesthesia
Arm Type
Experimental
Arm Description
Combined epidural-general anesthesia is performed during surgery; patient-controlled epidural analgesia is provided after surgery.
Intervention Type
Drug
Intervention Name(s)
General anesthesia alone
Intervention Description
General anesthesia is performed during surgery; patient-controlled intravenous analgesia is provided after surgery.
Intervention Type
Drug
Intervention Name(s)
Combined epidural-general anesthesia
Intervention Description
Combined epidural-general anesthesia is performed during surgery; patient-controlled epidural analgesia is provided after surgery.
Primary Outcome Measure Information:
Title
Recurrence-free survival after surgery.
Description
Time from surgery to the earliest date of recurrence/metastasis or death from any cause, whichever came first.
Time Frame
Up to 4 years after surgery.
Secondary Outcome Measure Information:
Title
Rate of intensive care unit admission after surgery.
Description
Rate of intensive care unit admission after surgery.
Time Frame
Up to 30 days after surgery.
Title
Incidence of postoperative complications during hospital stay.
Description
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.
Time Frame
Up to 30 days after surgery.
Title
Duration of chest tube placement.
Description
Duration of chest tube placement.
Time Frame
Up to 30 days after surgery.
Title
Length of stay in hospital after surgery.
Description
Length of stay in hospital after surgery.
Time Frame
Up to 30 days after surgery.
Title
Rate of all-cause mortality during hospital stay after surgery.
Description
Rate of all-cause mortality during hospital stay after surgery.
Time Frame
Up to 30 days after surgery.
Title
Overall survival rate after surgery.
Description
Time from surgery to all-cause death.
Time Frame
Up to 4 year after surgery.
Title
Cancer-specific survival after surgery.
Description
Time from surgery to cancer-specific death; deaths from other causes are censored at the time of death.
Time Frame
Up to 4 years after surgery.
Title
Activity engagement in 1-year survivors.
Description
Activity engagement is assessed by estimating metabolic equivalents (METs; 1 MET = 3·5 ml/min/kg resting oxygen consumption) for activity in daily life.
Time Frame
At the end of the first year after surgery.
Other Pre-specified Outcome Measures:
Title
Pain intensity after surgery.
Description
Assessed with the numeric rating score, an 11-point scale where 0 = no pain and 10 = the most severe pain.
Time Frame
During the first 3 days after surgery.
Title
Recurrence-free survival in cancer patients.
Description
Time from surgery to the earliest date of recurrence/metastasis or death from any cause, whichever came first.
Time Frame
Up to 4 years after surgery.
Title
Overall survival in cancer patients.
Description
Time from surgery to all-cause death.
Time Frame
Up to 4 years after surgery.
Title
Cancer-specific survival in cancer patients.
Description
Time from surgery to cancer-specific death; deaths from other causes are censored at the time of death.
Time Frame
Up to 4 years after surgery.
Title
Number of CD8+ and FOXP3+ T cells per mm2 tumor area (sub-study).
Description
Immunohistochemical staining of CD8 and FOXP3 molecules in excised lung adenocarcinoma specimens. Performed in part of enrolled patients.
Time Frame
After resection of lung adenocarcinoma specimens
Title
Percentage of NK-cells and T-cell subgroups in peripheral blood (sub-study).
Description
Measured by flow cytometry. Performed in part of enrolled patients.
Time Frame
Peripheral blood samples collected before induction, at the end of surgery and at 24 hours after surgery.
Title
Rate of chronic pain at 3 month and 6 month after surgery (sub-study).
Description
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.
Time Frame
At 3 months and 6 months after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (aged 18-80 years); Clinically diagnosed as primary non-small cell lung cancer of stage IA to IIIA, and scheduled for radical surgery; Agreed to receive patient-controlled analgesia after surgery. Exclusion Criteria: Distant metastasis, malignant tumor in other organs, or chemo-/radiotherapy or other anti-cancer therapy before surgery; Comorbid with autoimmune diseases, or glucocorticoid/immunosuppressant therapy within 1 year; History of schizophrenia, epilepsy or Parkinson disease, or unable to complete preoperative assessment due to severe dementia, language barrier, or end-stage disease; 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; History of anesthesia and/or surgery within 1 year; Contraindications to epidural anesthesia, including spinal deformity, coagulation dysfunction, local infection, and history of spinal trauma/surgery; Allergic to any medications used during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD, PhD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
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Epidural Anesthesia-analgesia and Long-term Survival After Lung Cancer Surgery

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