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

NCT03538782 | Completed

• 1 other identifier: Rad Exp PTBD 2018 V1.0
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Exposure

Keywords

percutaneous biliary drainage; radiation exposure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Fluoroscopy time

  From the beginning of the radiological examination until the end the examination (15 - 180 minutes)

• Number of images

  From the beginning of the radiological examination until the end the examination (15 -180 minutes)

Interventions

Percutaneous biliary drainage PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• the study center performs less than 10 PTBDs/year
• returned questionaire is incomplete

Sponsors & Collaborators

• Theresienkrankenhaus und St. Hedwig-Klinik GmbH: lead
• The Federal Office for Radiation Protection, Germany: collaborator

Study Sites (1)

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

Bad Homburg, 66421, Germany

Location

Related Publications (3)

• 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.

  PMID: 21792735 BACKGROUND

• 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.

  PMID: 16415136 BACKGROUND

• 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.

  PMID: 27384609 BACKGROUND

Related Links

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

Study Officials

• Alexander Schegerer, Dr.rer.nat.

  Federal Office of Radiation Protection, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 12, 2018
• First Posted: May 29, 2018
• Study Start: March 15, 2018
• Primary Completion: August 15, 2018
• Study Completion: October 15, 2018
• Last Updated: October 30, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)