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

NCT03538782 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2018-10-30

No results posted yet for this study

Summary

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.

Conditions

  • Radiation Exposure

Interventions

PROCEDURE

Percutaneous biliary drainage

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.

Sponsors & Collaborators

  • The Federal Office for Radiation Protection, Germany

    collaborator OTHER_GOV

  • Theresienkrankenhaus und St. Hedwig-Klinik GmbH

    lead OTHER

Principal Investigators

  • Alexander Schegerer, Dr.rer.nat. · Federal Office of Radiation Protection, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2018-08-15
Completion
2018-10-15

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03538782 on ClinicalTrials.gov