Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
NCT Number: NCT02801409
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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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100034, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Up to 30 days after surgery.
Rate of intensive care unit admission after surgery.
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.
Time frame: Up to 30 days after surgery.
Duration of chest tube placement.
Time frame: Up to 30 days after surgery.
Length of stay in hospital after surgery.
Time frame: Up to 30 days after surgery.
Rate of all-cause mortality during hospital stay after surgery.
Time frame: Up to 4 year after surgery.
Time from surgery to all-cause death.
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.
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.
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.
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.
Time frame: Up to 4 years after surgery.
Time from surgery to all-cause death.
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.
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.
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.
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.
Peking University First Hospital
Other
Effects of Epidural Anesthesia-analgesia on Long-term Survival in Patients After Lung Cancer Surgery: A Randomized Controlled Trial
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