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临床试验/NCT03538782
NCT03538782已完成不适用

Retrospective Multicenter Study on Patients Radiation Exposure in Percutaneous Transhepatic Biliary Drainage (PTBD) Procedures.

Theresienkrankenhaus und St. Hedwig-Klinik GmbH1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2018年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
600
试验地点
1
主要终点
Radiation Exposure

研究概览

简要总结

Percutaneous transhepatic biliary drainage (PTBD) procedures are associated with an elevated radiation exposure for the patient. In the recently published guideline of the Federal Office for Radiation Protection in Germany diagnostic reference levels (DRLs) for dose area products (DAP) are not defined for PTBD procedures due to insufficient data. The aim of this retrospective study is to give a nation-wide survey on patients radiation exposure in different PTBD procedures considering factors that may have an impact on increased radiation exposure like fluoroscopic-guided versus ultrasound-guided bile duct puncture.

详细描述

Percutaneous transhepatic biliary drainage (PTBD) procedures are associated with an elevated radiation exposure for the patient. Usually, radiation exposure in radiological interventions is measured by the dose area product (DAP). Diagnostic reference levels (DRLs) are based on the third quartiles (Q3) of the pooled dose area product (DAP) for the known interventional procedures. They have been introduced in the 1980s by the International Commission on Radiological Protection's (ICRP's) to reduce patients radiation exposure. In the recently published guideline of the Federal Office for Radiation Protection in Germany in 2016 DRLs are not defined for PTBD procedures due to insufficient data. Procedure complexity due to different techniques, patient anatomy, lesion characteristics and disease severity makes it difficult to define DRLs in this fluoroscopy-guided intervention. The ICRP recently published some recommendations on DRLs in medical imaging including radiological interventions. As DRLs are often missing in this field, it was suggested to analyze national data sets comprising dosimetric data from a large number of facilities. The aim of this retrospective study is to give a nation-wide survey on patients radiation exposure in different PTBD procedures considering factors that may have an impact on increased or decreased radiation exposure like fluoroscopic-guided versus ultrasound-guided bile duct puncture. A questionnaire was sent to 200 gastroenterological and radiological departments in university and non-university hospitals to analyze the last 10 - 30 consecutively performed PTBD procedures.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • •10 up to 30 consecutively performed PTBDs are documented in the study center
  • •body weight of the examined patients is about 60 - 80 kilogramms
  • •returned questionaire is complete in regard to DAP, fluoroscopy time, number of still images, characters of the intervention, characterization of the fluoroscopy device (manufacturer, date of first registration)

排除标准

  • •the study center performs less than 10 PTBDs/year
  • •returned questionaire is incomplete

结局指标

主要结局

Radiation Exposure

时间窗: From the beginning of the radiological examination until the end the examination (15 - 180 minutes)

Radiation Exposure for the patient is measured by the dose area product (cGy x cm2 resp.µGy x∙m2)

次要结局

  • Number of images(From the beginning of the radiological examination until the end the examination (15 -180 minutes))
  • Fluoroscopy time(From the beginning of the radiological examination until the end the examination (15 - 180 minutes))

研究者

发起方
Theresienkrankenhaus und St. Hedwig-Klinik GmbH
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Schmitz

Principal investigator

Theresienkrankenhaus und St. Hedwig-Klinik GmbH

研究点 (1)

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