Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- frequency of patients with postoperative major complications occurring within 30 days after surgery
研究概览
简要总结
Perioperative inflammation is harmful in cancer patients, namely in those undergoing surgery: it increases the risk of recurrence, decreases cancer survival, increases post-operative complications, and prolongs the time of recovery and the duration of hospital stay. Severe postoperative complications are also a risk factor of poor survival in cancer patients. Seemingly, some effective therapies currently used to improve the surgical outcome (e.g. immunonutrition, enhanced-recovery protocols) have an inflammatory effect. The modulation of perioperative inflammation therefore seems crucial to improve outcomes in patients undergoing surgery for digestive cancer.
A short perioperative treatment with high doses of corticosteroids has already been tested in several randomized trials. A recent meta-analysis showed that perioperative corticosteroids decreased inflammatory markers and might be associated with fewer complications in esophageal, liver, pancreatic and colorectal surgery: the decrease in the risk of postoperative complications was around 50% without adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >_18 years
- •Elective surgery for any digestive cancer (except purely hepatic surgery)
- •Patients operated in a curative intent
- •Patients who had given their written informed consent
- •Patients affiliated to a National health insurance scheme
排除标准
- •Emergency surgery
- •Pregnant or breastfeeding women
- •Patients with an ongoing oral treatment by steroids
- •Palliative surgery
- •Exclusive liver surgery
- •Concomitant hyperthermic intraperitoneal chemotherapy
- •Patient with at least one contra-indication to methylprednisolone treatment :
- •active infection
- •progressive/symptomatic viral infection (particularly hepatitis, herpes, chickenpox, herpes zoster)
- •uncontrolled psychotic state
- •hypersensitivity to methylprednisolone or to one of its excipients
- •ASA grade >3
- •Persons subject to a measure of legal protection (guardianship, tutorship)
- •Persons subject to a court order
- •Impossibility to adhere to the medical follow-up of the trial for geographical, social or psychological reasons
研究组 & 干预措施
Experimental group
干预措施: Injection of methylprednisolone (Drug)
Experimental group
干预措施: Blood samples (Biological)
Control group
干预措施: Injection of sodium chloride (Drug)
Control group
干预措施: Blood samples (Biological)
结局指标
主要结局
frequency of patients with postoperative major complications occurring within 30 days after surgery
时间窗: Through study completion, an average of 5 years
次要结局
未报告次要终点