Ultrasound and Fluoroscopy Guided Percutaneous Transhepatic Biliary Drainage in Patients With Malignant Bile Duct Obstruction - Impact of Puncture Angle on Total Fluoroscopy Time Reduction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 主要终点
- Total fluoroscopy time
研究概览
简要总结
The purpose of this study is to retrospectively assess the importance of initial bile duct puncture angle on total fluoroscopy time and overall efficacy during ultrasound and fluoroscopy guided percutaneous transhepatic biliary drainage (PTBD) performed for patients with malignant biliary hilar obstruction.
详细描述
Data used for this study will be collected from medical records of patients who underwent PTBD at the Interventional radiology department. Only patients who received percutaneous biliary drainage performed with right sided intercostal approach will be included in study. The initial puncture was ultrasound-guided in all patients. Any subsequent step of the procedure was performed under fluoroscopy. The cumulative fluoroscopy time (the total time of the exposure to X rays during intervention) after the US guided puncture was recorded. It will be used as an indirect measure of the complexity of the intervention and as an important parameter of radiation exposure. The patients will be divided into two groups based on the puncture angle: ≤30° group and >30° group. The two groups will be retrospectively analysed for technical success, fluoroscopy time and complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathological confirmation or imaging data confirming malignant disease causing bile duct obstruction, performance status 0-1.
排除标准
- •terminally ill patiens, performance status ˃2, hepatic decompensation (including ascites), severe underlying cardiac or renal diseases and coagulation disorders
结局指标
主要结局
Total fluoroscopy time
时间窗: during intervention
The initial puncture was ultrasound-guided in all patients. Any subsequent step of the procedure (PTBD) was performed under fluoroscopy. Total fluoroscopy time will be collected from Radiation Dose Report obtained in the angio suite workstation software ( General Electric Innova 540)
次要结局
未报告次要终点
研究者
Tamara Filipovic
Phd
Institut za Rehabilitaciju Sokobanjska Beograd
