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OpenTrials
Completed

NCT Number: NCT04653987

The Impact of Puncture Angle on Total Fluoroscopy Time Reduction During Percutaneous Biliary Drainage

The purpose of this study is to retrospectively assess the importance of initial bile duct puncture angle on total fluoroscopy time and overall efficacy during ultrasound and fluoroscopy guided percutaneous transhepatic biliary drainage (PTBD) performed for patients with malignant biliary hilar obstruction.

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Key information

Conditions

Interventional Radiology

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

Data used for this study will be collected from medical records of patients who underwent PTBD at the Interventional radiology department. Only patients who received percutaneous biliary drainage performed with right sided intercostal approach will be included in study. The initial puncture was ultrasound-guided in all patients. Any subsequent step of the procedure was performed under fluoroscopy. The cumulative fluoroscopy time (the total time of the exposure to X rays during intervention) after the US guided puncture was recorded. It will be used as an indirect measure of the complexity of the intervention and as an important parameter of radiation exposure. The patients will be divided into two groups based on the puncture angle: ≤30° group and >30° group. The two groups will be retrospectively analysed for technical success, fluoroscopy time and complications.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pathological confirmation or imaging data confirming malignant disease causing bile duct obstruction, performance status 0-1.

Exclusion criteria

  • terminally ill patiens, performance status ˃2, hepatic decompensation (including ascites), severe underlying cardiac or renal diseases and coagulation disorders

Treatment and study plan

Percutaneous biliary drainage

Procedure

Primary outcomes

  1. Total fluoroscopy time

    Time frame: during intervention

    The initial puncture was ultrasound-guided in all patients. Any subsequent step of the procedure (PTBD) was performed under fluoroscopy. Total fluoroscopy time will be collected from Radiation Dose Report obtained in the angio suite workstation software ( General Electric Innova 540)

Sponsors and collaborators

Lead sponsor

Institut za Rehabilitaciju Sokobanjska Beograd

Other

Collaborators

  • Klinički centar Srbije

Registry information

Official study title

Ultrasound and Fluoroscopy Guided Percutaneous Transhepatic Biliary Drainage in Patients With Malignant Bile Duct Obstruction - Impact of Puncture Angle on Total Fluoroscopy Time Reduction

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2020
Registry last updated
Dec 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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