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Completed

NCT Number: NCT03538782

Patients Radiation Exposure in Percutaneous Transhepatic Biliary Drainage (PTBD) Procedures

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.

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Key information

Conditions

Radiation Exposure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes Klinik für Innere Medizin II - Gastroenterologie und Endokrinologie

Bad Homburg, 66421, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

Percutaneous biliary drainage

Procedure

The initial puncture of the bile duct with an access needle is performed by ultrasound guidance or by fluoroscopic guidance. After injection of the radiopaque contrast media into the bile duct system the rest of the examination is performed by fluoroscopic guidance. All different PTBD procedures are analyzed: insertion, exchange or removal of a plastic catheter, metal stent implantation, PTBD with cholangioscopy, PTBD with ballon dilatation, PTBD with lithotrypsy or diagnostic percutaneous transhepatic cholangiography.

Primary outcomes

  1. Radiation Exposure

    Time frame: 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)

Secondary outcomes

  1. Fluoroscopy time

    Time frame: From the beginning of the radiological examination until the end the examination (15 - 180 minutes)

    Accumulated fluoroscopy time for the complete examination (minutes)

  2. Number of images

    Time frame: From the beginning of the radiological examination until the end the examination (15 -180 minutes)

    Number of still images which are produced during the whole examination (n)

Sponsors and collaborators

Lead sponsor

Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Other

Collaborators

  • The Federal Office for Radiation Protection, Germany

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 29, 2018
Registry last updated
Oct 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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