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

NCT ID: NCT04653987

Last Updated: 2020-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-11-30

Brief Summary

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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

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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.

Conditions

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Interventional Radiology

Keywords

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biliary drainage, fluoroscopy time, puncture angle

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Puncture angle : ≤30 (group I) >30 (group II)

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.

Percutaneous biliary drainage

Intervention Type PROCEDURE

Technical Parameters of all Interventions

Peripheral bile duct diameter, central bile duct diameter, number of punctures, type of drainage and total fluoroscopy time will be noted.

Percutaneous biliary drainage

Intervention Type PROCEDURE

Interventions

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Percutaneous biliary drainage

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Klinički centar Srbije

UNKNOWN

Sponsor Role collaborator

Institut za Rehabilitaciju Sokobanjska Beograd

OTHER

Sponsor Role lead

Responsible Party

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Tamara Filipovic

Phd

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dragan M Masulovic, Phd

Role: STUDY_DIRECTOR

Clinical Centre of Serbia

Other Identifiers

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717/3

Identifier Type: -

Identifier Source: org_study_id