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

Radiation Exposure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03538782
• Other study ID #: Rad Exp PTBD 2018 V1.0
• Status: Completed
• Start date: March 15, 2018
• Est. completion date: October 15, 2018

Study information

• Verified date: October 2018
• Source: Theresienkrankenhaus und St. Hedwig-Klinik GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: October 15, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Radiation Exposure

Intervention

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.

Locations

Country	Name	City	State
Germany	Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes Klinik für Innere Medizin II - Gastroenterologie und Endokrinologie	Bad Homburg

Sponsors (2)

Lead Sponsor	Collaborator
Theresienkrankenhaus und St. Hedwig-Klinik GmbH	The Federal Office for Radiation Protection, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Kloeckner R, Bersch A, dos Santos DP, Schneider J, Düber 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. — View Citation

Ruiz-Cruces R, Vano E, Carrera-Magariño F, Moreno-Rodriguez F, Soler-Cantos MM, Canis-Lopez M, Hernández-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, Muñoz 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, Cañete S. Diagnostic reference levels and complexity indices in interventional radiology: a national programme. Eur Radiol. 2016 Dec;26(12):4268-4276. Epub 2016 Jul 6. — View Citation

Stratakis 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation Exposure	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	Fluoroscopy time	Accumulated fluoroscopy time for the complete examination (minutes)	From the beginning of the radiological examination until the end the examination (15 - 180 minutes)
Secondary	Number of images	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)

External Links

•   Bekanntmachung der aktualisierten diagnostischen Referenzwerte für diagnostische und interventionelle Röntgenanwendungen 2016
•   Diagnostic Reference Levels in Medical Imaging ICRP Publication 135