Effects of Epidural Anesthesia-analgesia on Long-term Survival in Patients After Lung Cancer Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Recurrence-free survival after surgery.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
General anesthesia alone
General anesthesia is performed during surgery; patient-controlled intravenous analgesia is provided after surgery.
干预措施: General anesthesia alone (Drug)
Combined epidural-general anesthesia
Combined epidural-general anesthesia is performed during surgery; patient-controlled epidural analgesia is provided after surgery.
干预措施: Combined epidural-general anesthesia (Drug)
结局指标
主要结局
Recurrence-free survival after surgery.
时间窗: Up to 4 years after surgery.
Time from surgery to the earliest date of recurrence/metastasis or death from any cause, whichever came first.
次要结局
- Rate of intensive care unit admission after surgery.(Up to 30 days after surgery.)
- Incidence of postoperative complications during hospital stay.(Up to 30 days after surgery.)
- Duration of chest tube placement.(Up to 30 days after surgery.)
- Length of stay in hospital after surgery.(Up to 30 days after surgery.)
- Rate of all-cause mortality during hospital stay after surgery.(Up to 30 days after surgery.)
- Overall survival rate after surgery.(Up to 4 year after surgery.)
- Cancer-specific survival after surgery.(Up to 4 years after surgery.)
- Activity engagement in 1-year survivors.(At the end of the first year after surgery.)
研究者
Dong-Xin Wang
Professor
Peking University First Hospital