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

October 28, 2018 updated by: Daniel Schmitz, Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Retrospective Multicenter Study on 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Homburg, Germany, 66421
        • Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes Klinik für Innere Medizin II - Gastroenterologie und Endokrinologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All consecutively performed PTBDs in each study center are included taking account of the exclusion/inclusion criteria

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From the beginning of the radiological examination until the end the examination (15 - 180 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From the beginning of the radiological examination until the end the examination (15 - 180 minutes)
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)
From the beginning of the radiological examination until the end the examination (15 -180 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Collaborators

The Federal Office for Radiation Protection, Germany

Investigators

  • Study Director: Alexander Schegerer, Dr.rer.nat., Federal Office of Radiation Protection, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2018

Primary Completion (Actual)

August 15, 2018

Study Completion (Actual)

October 15, 2018

Study Registration Dates

First Submitted

May 12, 2018

First Submitted That Met QC Criteria

May 24, 2018

First Posted (Actual)

May 29, 2018

Study Record Updates

Last Update Posted (Actual)

October 30, 2018

Last Update Submitted That Met QC Criteria

October 28, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Rad Exp PTBD 2018 V1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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