Epidural Anesthesia-analgesia and Long-term Survival After Lung Cancer Surgery
NCT ID: NCT02801409
Last Updated: 2020-08-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
400 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-05-25
Study Completion Date
2019-11-30
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Lung Cancer
Thoracic Surgery
Anesthesia, Epidural
Neoplasm Recurrence, Local
Neoplasm Metastasis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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General anesthesia alone
General anesthesia is performed during surgery; patient-controlled intravenous analgesia is provided after surgery.
Group Type
ACTIVE_COMPARATOR
General anesthesia alone
Intervention Type
DRUG
General anesthesia is performed during surgery; patient-controlled intravenous analgesia is provided after surgery.
Combined epidural-general anesthesia
Combined epidural-general anesthesia is performed during surgery; patient-controlled epidural analgesia is provided after surgery.
Group Type
EXPERIMENTAL
Combined epidural-general anesthesia
Intervention Type
DRUG
Combined epidural-general anesthesia is performed during surgery; patient-controlled epidural analgesia is provided after surgery.
Interventions
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General anesthesia alone
General anesthesia is performed during surgery; patient-controlled intravenous analgesia is provided after surgery.
Intervention Type
DRUG
Combined epidural-general anesthesia
Combined epidural-general anesthesia is performed during surgery; patient-controlled epidural analgesia is provided after surgery.
Intervention Type
DRUG
Eligibility Criteria
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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.
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.
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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Peking University First Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Dong-Xin Wang
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Dong-Xin Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Site Status
Countries
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China
References
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BACKGROUND
Other Identifiers
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ChiCTR-TRC-14004136
Identifier Type: REGISTRY
Identifier Source: secondary_id
2013[653]
Identifier Type: -
Identifier Source: org_study_id
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