Preoperative Biliary Drainage in Malignant Biliary Obstruction - an Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 353
- 主要终点
- rate of serious complications
研究概览
简要总结
The first alarming symptom of a malignancy of the pancreas or periampullary tumor can be obstructive jaundice (OJ). Pancreato-duodenectomy (PD) combined with oncological treatment can provide long disease-free survival in resectable cases. The literature regarding the preoperative biliary drainage is controversial. The aim of this multicenter, prospective observational cohort study is to investigate the role of preoperative drainage, and to compare it with surgery alone.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients ≥ 18 years
- •OJ of malignant origin (pancreatic head or periampullary tumor)
- •Total bilirubin level ≥ 40 μmol per liter
- •Signed written informed consent
排除标准
- •Proved metastasis
- •Irresectable tumor
- •Neo-adjuvant chemotherapy
- •Co-existing malignancy
- •Patients not fit for resection
结局指标
主要结局
rate of serious complications
时间窗: 120 days
rate of serious complications after preoperative biliary drainage and surgery defined as: 1. Pancreatitis 2. New onset of cholecystitis 3. Cholangitis 4. Perforation 5. Hemorrhage after endoscopic retrograde cholangiopancreatography (ERCP) 6. Related to stent 1. Occlusion 2. Need for exchange Related to surgery 7. Pancreas anastomosis leakage
次要结局
- Length of hospitalization(120 days)
- Mortality(120 days)
研究者
Szűcs
Principal Investigator, Associate Professor of the First Surgical Department of the University of Semmelweis
University of Pecs