Clinical trial NCT02801409: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence-free survival after surgery.
timeFrame: Up to 4 years after surgery.
Secondary outcomes:
measure: Rate of intensive care unit admission after surgery.
timeFrame: Up to 30 days after surgery.
measure: Incidence of postoperative complications during hospital stay.
timeFrame: Up to 30 days after surgery.
measure: Duration of chest tube placement.
timeFrame: Up to 30 days after surgery.
measure: Length of stay in hospital after surgery.
timeFrame: Up to 30 days after surgery.
measure: Rate of all-cause mortality during hospital stay after surgery.
timeFrame: Up to 30 days after surgery.
measure: Overall survival rate after surgery.
timeFrame: Up to 4 year after surgery.
measure: Cancer-specific survival after surgery.
timeFrame: Up to 4 years after surgery.
measure: Activity engagement in 1-year survivors.
timeFrame: At the end of the first year after surgery.
Other outcomes:
measure: Pain intensity after surgery.
timeFrame: During the first 3 days after surgery.
measure: Recurrence-free survival in cancer patients.
timeFrame: Up to 4 years after surgery.
measure: Overall survival in cancer patients.
timeFrame: Up to 4 years after surgery.
measure: Cancer-specific survival in cancer patients.
timeFrame: Up to 4 years after surgery.
measure: Number of CD8+ and FOXP3+ T cells per mm2 tumor area (sub-study).
timeFrame: After resection of lung adenocarcinoma specimens
measure: Percentage of NK-cells and T-cell subgroups in peripheral blood (sub-study).
timeFrame: Peripheral blood samples collected before induction, at the end of surgery and at 24 hours after surgery.
measure: Rate of chronic pain at 3 month and 6 month after surgery (sub-study).
timeFrame: At 3 months and 6 months after surgery.
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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