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

• ClinicalTrials.gov Identifier: NCT03538782
• Recruitment Status: Completed
• First Posted: May 29, 2018
• Last Update Posted: October 30, 2018
• Sponsor: Theresienkrankenhaus und St. Hedwig-Klinik GmbH
• Collaborator: The Federal Office for Radiation Protection, Germany
• Information provided by (Responsible Party): Daniel Schmitz, Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Study Description

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.

Condition or disease	Intervention/treatment
Radiation Exposure	Procedure: Percutaneous biliary drainage

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

• Study Type: Observational
• Actual Enrollment: 600 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Retrospective Multicenter Study on Patients Radiation Exposure in Percutaneous Transhepatic Biliary Drainage (PTBD) Procedures.
• Actual Study Start Date: March 15, 2018
• Actual Primary Completion Date: August 15, 2018
• Actual Study Completion Date: October 15, 2018

Groups and Cohorts

Intervention Details:

• 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.

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. 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)
2. 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

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

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

Contacts and Locations

Locations

Germany

Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes Klinik für Innere Medizin II - Gastroenterologie und Endokrinologie

Bad Homburg, Germany, 66421

Sponsors and Collaborators

Theresienkrankenhaus und St. Hedwig-Klinik GmbH

The Federal Office for Radiation Protection, Germany

Investigators

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

More Information

Additional Information:

Diagnostic Reference Levels in Medical Imaging ICRP Publication 135 

Bekanntmachung der aktualisierten diagnostischen Referenzwerte für diagnostische und interventionelle Röntgenanwendungen 2016 

Publications:

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.

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.

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.

• Responsible Party: Daniel Schmitz, Principal investigator, Theresienkrankenhaus und St. Hedwig-Klinik GmbH
• ClinicalTrials.gov Identifier: NCT03538782
• Other Study ID Numbers: Rad Exp PTBD 2018 V1.0
• First Posted: May 29, 2018
• Last Update Posted: October 30, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daniel Schmitz, Theresienkrankenhaus und St. Hedwig-Klinik GmbH:

percutaneous biliary drainage; radiation exposure