NCT04653987

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
Last Updated

December 4, 2020

Status Verified

November 1, 2020

Enrollment Period

4.8 years

First QC Date

November 28, 2020

Last Update Submit

November 28, 2020

Conditions

Interventional Radiology

Keywords

biliary drainage, fluoroscopy time, puncture angle

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Procedure: Percutaneous biliary drainage

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.

Procedure: Percutaneous biliary drainage

Interventions

Percutaneous biliary drainagePROCEDURE
Puncture angle : ≤30 (group I) >30 (group II)Technical Parameters of all Interventions

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with malignant biliary obstruction who underwent PTBD performed by right sided intercostal approach (US and fluorocopy guided).

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Dragan M Masulovic, Phd

    Clinical Centre of Serbia

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

November 28, 2020

First Posted

December 4, 2020

Study Start

January 1, 2016

Primary Completion

October 1, 2020

Study Completion

November 1, 2020

Last Updated

December 4, 2020

Record last verified: 2020-11