An interventional study of General anesthesia alone and Combined epidural-general anesthesia in Lung Cancer, Thoracic Surgery and Anesthesia, Epidural, sponsored by Peking University First Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-08-27.
Sponsored by Peking University First Hospital · Not applicable, Interventional, and Prevention
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 400 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
General anesthesia is performed during surgery; patient-controlled intravenous analgesia is provided after surgery.
Drug: General anesthesia alone
Combined epidural-general anesthesia is performed during surgery; patient-controlled epidural analgesia is provided after surgery.
Drug: Combined epidural-general anesthesia
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.
Recurrence-free survival 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.
Rate of intensive care unit admission after surgery.
Rate of intensive care unit admission after surgery.
Time frame: Up to 30 days 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.
Time frame: Up to 30 days after surgery.
Duration of chest tube placement.
Duration of chest tube placement.
Time frame: Up to 30 days after surgery.
Length of stay in hospital 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.
Rate of all-cause mortality during hospital stay after surgery.
Time frame: Up to 30 days after surgery.
Overall survival rate after surgery.
Time from surgery to all-cause death.
Time frame: Up to 4 year after surgery.
Cancer-specific survival after surgery.
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.
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.
Time frame: At the end of the first year after surgery.
Pain intensity after surgery.
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.
Recurrence-free survival in cancer patients.
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.
Overall survival in cancer patients.
Time from surgery to all-cause death.
Time frame: Up to 4 years after surgery.
Cancer-specific survival in cancer patients.
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.
Number of CD8+ and FOXP3+ T cells per mm2 tumor area (sub-study).
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
Percentage of NK-cells and T-cell subgroups in peripheral blood (sub-study).
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.
Rate of chronic pain at 3 month and 6 month after surgery (sub-study).
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.
Plan to share: No
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peking University First Hospital