A New Strategy for Preoperative Drainage of Resectable Pancreatic Head Cancer Combined Severe Obstructive Jaundice, a Multicenter, Open-label, Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- In-hospital complications
研究概览
简要总结
Severe obstructive jaundice caused by pancreatic head cancer usually requires preoperative biliary drainage, but its necessity and effectiveness are controversial, and specific strategies lack clear standards. This study proposed a new strategy for preoperative biliary drainage using serum prealbumin as the main evaluation index, and compared it with the traditional strategy using serum total bilirubin as the main evaluation index. Through a randomized, controlled, multicenter prospective study, we explored the effects of different drainage strategies on the incidence of in-hospital complications and long-term prognosis of patients with resectable pancreatic head cancer, guided clinical decisions on preoperative drainage time and surgical timing, and provided high-quality evidence-based medicine for preoperative biliary drainage of pancreatic head cancer.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological diagnosis of pancreatic head cancer, or clinical diagnosis of pancreatic head cancer after multidisciplinary discussion, clear presence of obstructive jaundice caused by pancreatic head tumor, and planned to undergo radical pancreaticoduodenectomy
- •Preoperative imaging stage is resectable
- •Baseline serum total bilirubin ≥ 250μmol/L, and no history of preoperative biliary drainage
- •Age >18 and ≤75 years old
- •ECOG(Eastern Cooperative Oncology Group) physical score ≤ 2
- •Signed informed consent, received preoperative endoscopic biliary drainage (ERCP) and radical surgery timing evaluation
排除标准
- •Combined with other malignant tumors
- •Combined with uncontrolled medical diseases or organ dysfunction and other absolute counterindications for surgery
- •Pregnant and lactating women
- •Patients who cannot tolerate preoperative biliary drainage or radical surgery
- •Other situations that are not suitable for inclusion in clinical trials
结局指标
主要结局
In-hospital complications
时间窗: During hospitalization, up tp 3 months
In-hospital complications are comprehensively evaluated by the chief surgeon, responsible doctor and their team based on clinical manifestations, laboratory tests, etc., and reviewed by the expert committee of this study. The name of the complication, time of occurrence, treatment measures and outcome are strictly recorded.
次要结局
- Long-term complications(12 months after discharge)
- Recurrence/metastasis(12 months after discharge)
- Mortality(12 months after discharge)