Effect of Perioperative Epidural Block and Dexamethasone on Outcome of Patients Undergoing Pancreatic Cancer Surgery: a 2×2 Factorial Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- 2-year overall survival
研究概览
简要总结
Pancreatic cancer remains a devastating disease with an average 5-year survival rate of about 3-5%. Previous retrospective studies showed that perioperative epidural block and/or dexamethasone are associated with improved outcome after cancer surgery. This randomized trial aims to investigate the effect of perioperative epidural block and/or dexamethasone on long-term survival in patients following pancreatic cancer surgery.
详细描述
Pancreatic cancer is the fourth leading cause of cancer-related death in the world, and is estimated to become the second one in 2030. For patients with resectable pancreatic cancer, radical surgery is the first-line therapy. However, the clinical outcomes remain poor even after radical resection, as the incidence of postoperative morbidity is up to 50% and the 5-year survival rate remains below 30%.
For patients undergoing major intraabdominal surgery, epidural block may provide advantages by blocking the afferent nociceptive stimuli, providing better pain relief, decreasing opioid consumption, and alleviating stress response. These effects may be helpful in preserving immune function. Some retrospective studies showed that epidural block is associated with delayed cancer recurrence/metastasis and improved survival after cancer surgery.
Low-dose dexamethasone is frequently used to prevent postoperative nausea and vomiting. Recent evidences from retrospective studies suggest that perioperative dexamethasone may also affect long-term outcome after cancer surgery. For example, in patients undergoing lung cancer surgery, intraoperative dexamethasone is associated with improved recurrence-free and overall survival. Similar results are also reported in patients after pancreatic cancer surgery.
The investigators hypothesize that perioperative epidural block and dexamethasone may improve survival in patients after radical pancreatic surgery. The purpose of this study is to investigate whether perioperative epidural block and/or dexamethasone can improve 2-year survival in patients after pancreatic cancer surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
For dexamethasone administration, all the participants, care providers, investigators, and outcomes assessors are masked. For epidural block, outcome assessors are masked.
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥45 and <90 years;
- •Clinically diagnosed as resectable or possibly resectable pancreatic cancer and scheduled to undergo radical surgery;
- •Agreed to receive epidural block and postoperative patient-controlled analgesia;
- •Agreed to participate in the study and provided written informed consent.
排除标准
- •Clinical evidence of unresectable pancreatic cancer or plan to undergo biopsy;
- •Previous surgery for pancreatic cancer, scheduled to undergo resurgery for recurrence or metastasis;
- •Complicated with primary malignant tumor in other organ(s), either previously or at present;
- •Complicated with autoimmune diseases, receiving either glucocorticoids or other immunosuppressants before surgery;
- •Unable to complete preoperative evaluation due to severe dementia, language barrier, coma, or end-stage diseases;
- •Severe hepatic dysfunction (Child-Pugh C), severe renal insufficiency (serum creatinine >442 µmol/L or requirement of renal replacement therapy), or American Society of Anesthesiologists classification ≥V；
- •Contradictions to epidural anesthesia, including spinal malformation, history of spinal surgery, coagulation disorder, suspected infection at the site of puncture, or severe low back pain;
- •Other conditions that are considered unsuitable for study participation;
- •Refused to participate in the study.
研究组 & 干预措施
Epidural block
Patients in this group receive combined epidural-general anesthesia (0.375% ropivacaine for epidural block), without perioperative dexamethasone. Patient-controlled epidural analgesia is provided after surgery.
干预措施: Epidural block (Other)
Dexamethasone
Patients in this group receive dexamethasone (10 mg) before anesthesia induction and general anesthesia, without epidural block. Patient-controlled intravenous analgesia is provided after surgery.
干预措施: Dexamethasone (Drug)
Epidural block+Dexamethasone
Patients this group receive dexamethasone (10 mg) before anesthesia induction and combined epidural-general anesthesia (0.375% ropivacaine for epidural block). Patient-controlled epidural analgesia is provided after surgery.
干预措施: Epidural block (Other)
Epidural block+Dexamethasone
Patients this group receive dexamethasone (10 mg) before anesthesia induction and combined epidural-general anesthesia (0.375% ropivacaine for epidural block). Patient-controlled epidural analgesia is provided after surgery.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
2-year overall survival
时间窗: Up to 2 years after surgery.
2-year overall survival
次要结局
- Length of stay in hospital after surgery.(Up to 30 days after surgery.)
- Overall postoperative complications.(Up to 30 days after surgery.)
- Postoperative gastrointestinal complications.(Up to 30 days after surgery.)
- All-cause 30-day mortality.(Up to 30 days after surgery.)
- 2-year progression-free survival(Up to 2 years after surgery.)
- Quality of life in 1- and 2-year survivors.(At the end of the first and second year after surgery.)
- Hospital readmission within 2 years after surgery.(Up to 2 years after surgery.)
研究者
Dong-Xin Wang
Chairman, Department of Anaesthesiology and Critical Care Medicine
Peking University First Hospital