Ignite Creation Date:
2024-05-06 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03538782
Status:
COMPLETED
Last Update Posted:
2018-10-30
First Post:
2018-05-12
Brief Title:
Patients Radiation Exposure in Percutaneous Transhepatic Biliary Drainage PTBD Procedures
Sponsor:
Theresienkrankenhaus und St Hedwig-Klinik GmbH
Organization:
Theresienkrankenhaus und St Hedwig-Klinik GmbH
Study Overview
Official Title:
Retrospective Multicenter Study on Patients Radiation Exposure in Percutaneous Transhepatic Biliary Drainage PTBD Procedures
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Protections ICRPs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None