Evaluation of Preoperative Biliary Drainage on Outcome of Pancreatoduodenectomy: A Multicenter Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- Incidence of Infectious Complications
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of preoperative biliary drainage (PBD) which is performed prior to pancreatoduodenectomy candidates with obstructive jaundice by observing the prevalence of drainage and surgery related complications, hospital stay, medical cost and life quality compared to surgery alone. It is anticipated that PBD can reduce the prevalence of complications and improve the outcome of pancreatoduodenectomy.
详细描述
Obstructive jaundice is a common symptom in patients with pancreatic head cancer or peri-ampullary cancer. It is regarded that proper surgical resection is the only possible way of radical cure for those patients without evidence of metastasis. Since high preoperative bilirubin level is suggested to be a risk factor for pancreatoduodenectomy, preoperative biliary drainage has been applied to clinical practice to improve the outcome of surgery. However, results from previous studies have inconsistent results showing that PBD may have adverse effect on patients by elevating the prevalence of complications. Since PBD is widely performed worldwide, its value needs to be clarified. Thus the present study is designed to systematically evaluate the value of PBD via recruiting participants who may most likely benefit from PBD. It is anticipated that results from this study can present an instructive conclusion on whether PBD should be performed prior to pancreatoduodenectomy as well as reveal the preferable type of PBD.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 70 years old
- •CT (Computed Tomography), CTA (Computed Tomographic Angiography), MRI (Magnetic Resonance Imaging) or ultrasonic test suggested pancreatic head carcinoma or periampullary carcinoma with obstructive jaundice
- •First routine test of serum bilirubin above 250μmol per liter
排除标准
- •Distant metastasis in liver, lung or other sites
- •Invasion of local blood vessels (e.g. aorta, portal vein, postcava)
- •Poor physical condition, unable to tolerate anesthesia and surgery (e.g. severe cardio-pulmonary diseases, blood coagulation disorders)
- •With cholangitis, active hepatitis or other diseases which should be excluded from study according to the investigators
结局指标
主要结局
Incidence of Infectious Complications
时间窗: up to 12 months
次要结局
- Life Quality Score(up to 12 months)
- Incidence of Hemorrhagic Complications(up to 6 months)
- Liver Function Evaluation(up to 6 months)
- Incidence of Bile Leakage(up to 6 months)
- Digestive Function Recovery(up to 6 months)
- Incidence of Pancreatic Leakage(up to 6 months)
研究者
Huai-zhi Wang
Doctor
Southwest Hospital, China