The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The Comprehensive Complication Index (CCI)
研究概览
简要总结
The primary objective of this clinical trial is evaluate the effect of dexamethasone on postoperative complications after pancreaticoduodenectomy.
详细描述
This is a multicentric, prospective, randomized, double-blind, pragmatic, placebo-control study. Patients who are going to receive elective pancreaticoduodenectomy will be randomized to receive 0.2 mg/kg dexamethasone or saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia. The primary outcome is the Comprehensive Complication Index (CCI) score within 30 days after the operation, which will be compared between these two groups .
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The patients, surgeons, anesthetists, data collectors, and outcome assessors are all blinded. Only the data manager and the specific study coordinator are unblinded to the group allocation.
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
- •Adult patients ≥18 years of age;
- •An indication for elective PD surgery;
- •Patients understand the nature of this trial and are willing to comply;
- •Patients are able to provide written informed consent;
排除标准
- •Current or recent (within preceding 1 month) systemic use of glucocorticoids;
- •Distant metastases including peritoneal carcinomatosis, liver metastases, distant lymph node metastases, and involvement of other organs;
- •Patients may undergo left, central, or total pancreatectomy other than PD;
- •Palliative surgery；
- •Patients with high operative risk, as defined by the American Society of Anesthesiologists (ASA), with a score ≥ 4;
- •Synchronous malignancy in other organs or second cancer requiring resection during the same procedure;
- •Pregnant and lactating women.
研究组 & 干预措施
Dexamethasone
Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia
干预措施: Dexamethasone (Drug)
Saline placebo
Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia
干预措施: Saline placebo (Drug)
结局指标
主要结局
The Comprehensive Complication Index (CCI)
时间窗: Within 30 days after the operation
The Comprehensive Complication Index (CCI) score within 30 days after the operation. The CCI takes into account all cumulative complications and receives values between 0 and 100. The weight of complication (wC) of the CCI is based on the established Clavien-Dindo classification.
次要结局
- The incidence of major complications (Clavien-Dindo≥3)(30 days)
- The incidence of postoperative pancreatic fistula (ISGPS classification)(30 days)
- The incidence of postpancreatectomy acute pancreatitis (ISGPS classification)(30 days)
- The incidence of infection (including wound infection and intra-abdominal abscess)(30 days)
- Postoperative length of stay(1 day of discharge)
- The incidence of relaparotomy(30 days)
- Mortality(60 days)