跳至主要内容
临床试验/NCT04653987
NCT04653987已完成不适用

Ultrasound and Fluoroscopy Guided Percutaneous Transhepatic Biliary Drainage in Patients With Malignant Bile Duct Obstruction - Impact of Puncture Angle on Total Fluoroscopy Time Reduction

Institut za Rehabilitaciju Sokobanjska Beograd0 个研究点目标入组 130 人开始时间: 2016年1月最近更新:
适应症

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

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

发起方
Institut za Rehabilitaciju Sokobanjska Beograd
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tamara Filipovic

Phd

Institut za Rehabilitaciju Sokobanjska Beograd

相似试验

The Impact of Puncture Angle on Total Fluoroscopy... | 临床试验