Radiation ExposureNCT03538782
Patients Radiation Exposure in Percutaneous Transhepatic Biliary Drainage (PTBD) Procedures
An observational study of Radiation Exposure, run by Theresienkrankenhaus und St. Hedwig-Klinik GmbH at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Exposure
- What is being tested?
- Percutaneous biliary drainage
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- 15 Mar 2018to 15 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutively performed PTBDs in each study center are included taking account of the exclusion/inclusion criteria
Who may be able to join
- 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)
Who cannot join
- the study center performs less than 10 PTBDs/year
- returned questionaire is incomplete
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes Klinik für Innere Medizin II - Gastroenterologie und Endokrinologie
Bad Homburg, 66421
About this study
Official title: 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.
Read the 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.
- Conditions
- Radiation Exposure
- Being tested
- Percutaneous biliary drainage
- Keywords
- percutaneous biliary drainage, radiation exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous biliary drainageProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation Exposure
Radiation Exposure for the patient is measured by the dose area product (cGy x cm2 resp.µGy x∙m2)
Measured: From the beginning of the radiological examination until the end the examination (15 - 180 minutes)
Secondary outcomes (2)
Fluoroscopy time
Accumulated fluoroscopy time for the complete examination (minutes)
Measured: From the beginning of the radiological examination until the end the examination (15 - 180 minutes)
Number of images
Number of still images which are produced during the whole examination (n)
Measured: From the beginning of the radiological examination until the end the examination (15 -180 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start15 Mar 2018
- Primary completion15 Aug 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Radiation ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theresienkrankenhaus und St. Hedwig-Klinik GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- The Federal Office for Radiation Protection, Germany
- Responsible party
- Principal investigator, Daniel Schmitz, Theresienkrankenhaus und St. Hedwig-Klinik GmbH
- Investigators
- Alexander Schegerer, Dr.rer.nat., Study director, Federal Office of Radiation Protection, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538782
- Sponsor's protocol ID
- Rad Exp PTBD 2018 V1.0
- Status last verified
- Oct 2018
- First submitted
- 12 May 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kloeckner R, Bersch A, dos Santos DP, Schneider J, Duber C, Pitton MB. Radiation exposure in nonvascular fluoroscopy-guided interventional procedures. Cardiovasc Intervent Radiol. 2012 Jun;35(3):613-20. doi: 10.1007/s00270-011-0206-y. Epub 2011 Jul 27.
PubMed 21792735Stratakis J, Damilakis J, Hatzidakis A, Perisinakis K, Gourtsoyiannis N. Radiation dose and risk from fluoroscopically guided percutaneous transhepatic biliary procedures. J Vasc Interv Radiol. 2006 Jan;17(1):77-84. doi: 10.1097/01.RVI.0000188754.97465.13.
PubMed 16415136Ruiz-Cruces R, Vano E, Carrera-Magarino F, Moreno-Rodriguez F, Soler-Cantos MM, Canis-Lopez M, Hernandez-Armas J, Diaz-Romero FJ, Rosales-Espizua F, Fernandez-Soto JM, Sanchez-Casanueva R, Martin-Palanca A, Perez-Martinez M, Gil-Agudo A, Zarca-Diaz MA, Parra-Osorio V, Munoz Ruiz-Canela JJ, Moreno-Sanchez T, Lopez-Medina A, Moreno-Saiz C, Galan-Montenegro P, Gallego-Beuter JJ, Gonzalez-de-Garay M, Zapata-Jimenez JC, Pastor-Vega JM, Canete S. Diagnostic reference levels and complexity indices in interventional radiology: a national programme. Eur Radiol. 2016 Dec;26(12):4268-4276. doi: 10.1007/s00330-016-4334-2. Epub 2016 Jul 6.
PubMed 27384609
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Multicenter Study on Patients Radiation Exposure in Percutaneous Transhepatic Biliary Drainage (PTBD) Procedures.
- ClinicalTrials.gov ID
- NCT03538782
- Acronym / sponsor ID
- Rad Exp PTBD 2018 V1.0
- Conditions
- Radiation Exposure
- Keywords
- percutaneous biliary drainage, radiation exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Theresienkrankenhaus und St. Hedwig-Klinik GmbHUniversity, hospital or other
- Collaborators
- The Federal Office for Radiation Protection, Germany
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutively performed PTBDs in each study center are included taking account of the exclusion/inclusion criteria
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- the study center performs less than 10 PTBDs/year
- returned questionaire is incomplete
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous biliary drainageThe 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. | Procedure or surgery | – |
Primary outcome
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)
2 secondary outcomes
Fluoroscopy time
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Background: PubMed 21792735Kloeckner R, Bersch A, dos Santos DP, Schneider J, Duber C, Pitton MB. Radiation exposure in nonvascular fluoroscopy-guided interventional procedures. Cardiovasc Intervent Radiol. 2012 Jun;35(3):613-20. doi: 10.1007/s00270-011-0206-y. Epub 2011 Jul 27.
- Background: PubMed 16415136Stratakis J, Damilakis J, Hatzidakis A, Perisinakis K, Gourtsoyiannis N. Radiation dose and risk from fluoroscopically guided percutaneous transhepatic biliary procedures. J Vasc Interv Radiol. 2006 Jan;17(1):77-84. doi: 10.1097/01.RVI.0000188754.97465.13.
- Background: PubMed 27384609Ruiz-Cruces R, Vano E, Carrera-Magarino F, Moreno-Rodriguez F, Soler-Cantos MM, Canis-Lopez M, Hernandez-Armas J, Diaz-Romero FJ, Rosales-Espizua F, Fernandez-Soto JM, Sanchez-Casanueva R, Martin-Palanca A, Perez-Martinez M, Gil-Agudo A, Zarca-Diaz MA, Parra-Osorio V, Munoz Ruiz-Canela JJ, Moreno-Sanchez T, Lopez-Medina A, Moreno-Saiz C, Galan-Montenegro P, Gallego-Beuter JJ, Gonzalez-de-Garay M, Zapata-Jimenez JC, Pastor-Vega JM, Canete S. Diagnostic reference levels and complexity indices in interventional radiology: a national programme. Eur Radiol. 2016 Dec;26(12):4268-4276. doi: 10.1007/s00330-016-4334-2. Epub 2016 Jul 6.
- Diagnostic Reference Levels in Medical Imaging ICRP Publication 135Link provided by the sponsor.
- Bekanntmachung der aktualisierten diagnostischen Referenzwerte für diagnostische und interventionelle Röntgenanwendungen 2016Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Schegerer, Dr.rer.nat. study director
Federal Office of Radiation Protection, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Exposure, run by Theresienkrankenhaus und St. Hedwig-Klinik GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation Exposure (time frame: From the beginning of the radiological examination until the end the examination (15 - 180 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03538782, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.