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

Interventional Radiology Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04653987
• Other study ID #: 717/3
• Status: Completed
• Start date: January 2016
• Est. completion date: November 2020

Study information

• Verified date: November 2020
• Source: Institut za Rehabilitaciju Sokobanjska Beograd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: November 2020
• Est. primary completion date: October 2020
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Interventional Radiology

Intervention

Procedure:
• Percutaneous biliary drainage

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Institut za Rehabilitaciju Sokobanjska Beograd	Klinicki centar Srbije

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total fluoroscopy time	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)	during intervention