Clinical trial NCT03538782: Patients Radiation Exposure in Percutaneous Transhepatic Biliary Drainage (PTBD) Procedures
Official title: Retrospective Multicenter Study on Patients Radiation Exposure in Percutaneous Transhepatic Biliary Drainage (PTBD) Procedures.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiation Exposure
Keywords: percutaneous biliary drainage
radiation exposure
Lead sponsor: Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Sponsor class: OTHER
Collaborators: name: The Federal Office for Radiation Protection, Germany
First posted: 2018-05-29
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutively performed PTBDs in each study center are included taking account of the exclusion/inclusion criteria

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Radiation Exposure
timeFrame: From the beginning of the radiological examination until the end the examination (15 - 180 minutes)
Secondary outcomes:
measure: Fluoroscopy time
timeFrame: From the beginning of the radiological examination until the end the examination (15 - 180 minutes)
measure: Number of images
timeFrame: From the beginning of the radiological examination until the end the examination (15 -180 minutes)
Other outcomes:
Locations:
city: Bad Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes Klinik für Innere Medizin II - Gastroenterologie und Endokrinologie
Study officials:
affiliation: Federal Office of Radiation Protection, Germany
name: Alexander Schegerer, Dr.rer.nat.
role: STUDY_DIRECTOR
References:
citation: 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.
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. doi: 10.1097/01.RVI.0000188754.97465.13.
citation: Ruiz-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.