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

Completed

• Conditions: Interventional Radiology
• Interventions: Procedure: Percutaneous biliary drainage

• Registration Number: NCT04653987
• Lead Sponsor: Institut za Rehabilitaciju Sokobanjska Beograd

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2020-10
• Status Verified: 2020-11
• Study Completion: 2020-11
• Study First Submitted: 2020-11-28
• Study First Submitted QC: 2020-11-28
• Last Update Submitted: 2020-11-28
• Study First Posted: 2020-12-04
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Technical Parameters of all Interventions	Percutaneous biliary drainage	Peripheral bile duct diameter, central bile duct diameter, number of punctures, type of drainage and total fluoroscopy time will be noted.
Puncture angle : ≤30 (group I) >30 (group II)	Percutaneous biliary drainage	The patients will be divided into two groups based on the puncture angle: ≤30° group and \>30° group. The two groups will be retrospectively analyzed for technical success, fluoroscopy time and complications.

Primary Outcome Measures

Name	Time	Method
Total fluoroscopy time	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)