The Influence of Antibiotics on the Incidence of Biliary Tract Infections After PTCD for Malignant Obstructive Jaundice
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of patients with biliary tract infection after surgery
研究概览
简要总结
To investigate the influence of antibiotics on the incidence of biliary tract infections after PTCD for malignant obstructive jaundice.
详细描述
This project designed a large-scale, single-center, prospective randomized controlled clinical trial to explore the impact of antibiotics on the incidence of biliary tract infections after PTCD with malignant obstructive jaundice. This study will provide evidence-based medical evidence for the need for routine use of antibiotics to prevent biliary tract infections after PTCD with malignant obstructive jaundice, and provide references for clinicians to prevent patients from PTCD infections.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old;
- •ECOG score 0-1 before operation;
- •Patients diagnosed as pancreatic head cancer and periampullary cancer according to preoperative imaging, including ampullary cancer, extrahepatic bile duct cancer and duodenal papillary cancer;
- •Bilirubin>200 mmol/L before PTCD , and the duration of PTCD continuous drainage >2 weeks;
- •Volunteer to participate and sign the informed consent form;
排除标准
- •Decompensated liver cirrhosis, acute and chronic hepatitis and other diseases before surgery;
- •A history of other malignant tumors before surgery;
- •Duration of preoperative PTCD drainage<2 weeks;
- •Jaundice caused by other reasons besides cancer around the ampulla and cancer of the head of the pancreas;
结局指标
主要结局
Incidence of patients with biliary tract infection after surgery
时间窗: October 2020 to June 2023
Incidence of patients with biliary tract infection after surgery
次要结局
- Decline rate of bilirubin in patients after PTCD(October 2020 to June 2023)
研究者
Xian-Jun Yu
President of Shanghai Pancreatic Cancer Institute
Fudan University