Interventional RadiologyNCT04653987
The Impact of Puncture Angle on Total Fluoroscopy Time Reduction During Percutaneous Biliary Drainage
An observational study of Interventional Radiology, run by Institut za Rehabilitaciju Sokobanjska Beograd.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Interventional Radiology
- What is being tested?
- Percutaneous biliary drainage
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Nov 2020
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients with malignant biliary obstruction who underwent PTBD performed by right sided intercostal approach (US and fluorocopy guided).
Who may be able to join
- pathological confirmation or imaging data confirming malignant disease causing bile duct obstruction, performance status 0-1.
Who cannot join
- terminally ill patiens, performance status ˃2, hepatic decompensation (including ascites), severe underlying cardiac or renal diseases and coagulation disorders
About this study
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
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.
Read the 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.
- Conditions
- Interventional Radiology
- Being tested
- Percutaneous biliary drainage
- Keywords
- biliary drainage, fluoroscopy time, puncture angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous biliary drainageProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Percutaneous biliary drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: during intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study startJan 2016
- Primary completionOct 2020
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interventional RadiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 130 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Institut za Rehabilitaciju Sokobanjska Beograd
- Sponsor type
- University, hospital or other
- Collaborators
- Klinički centar Srbije
- Responsible party
- Principal investigator, Tamara Filipovic, Institut za Rehabilitaciju Sokobanjska Beograd
- Investigators
- Dragan M Masulovic, Phd, Study director, Clinical Centre of Serbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653987
- Sponsor's protocol ID
- 717/3
- Status last verified
- Nov 2020
- First submitted
- 28 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04653987
- Acronym / sponsor ID
- 717/3
- Conditions
- Interventional Radiology
- Keywords
- biliary drainage, fluoroscopy time, puncture angle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Institut za Rehabilitaciju Sokobanjska BeogradUniversity, hospital or other
- Collaborators
- Klinički centar Srbije
- Study start
- Jan 2016 (actual)
- Primary completion
- Oct 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Puncture angle : ≤30 (group I) >30 (group II) | – | Procedure: Percutaneous biliary drainageThe 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. |
| Technical Parameters of all Interventions | – | Procedure: Percutaneous biliary drainagePeripheral bile duct diameter, central bile duct diameter, number of punctures, type of drainage and total fluoroscopy time will be noted. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with malignant biliary obstruction who underwent PTBD performed by right sided intercostal approach (US and fluorocopy guided).
Key inclusion criteria (1 listed)
- pathological confirmation or imaging data confirming malignant disease causing bile duct obstruction, performance status 0-1.
Key exclusion criteria (1 listed)
- terminally ill patiens, performance status ˃2, hepatic decompensation (including ascites), severe underlying cardiac or renal diseases and coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous biliary drainage | Procedure or surgery | Puncture angle : ≤30 (group I) >30 (group II), Technical Parameters of all Interventions |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dragan M Masulovic, Phd study director
Clinical Centre of Serbia
Questions about this trial
What is this clinical trial studying?
An observational study of Interventional Radiology, run by Institut za Rehabilitaciju Sokobanjska Beograd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total fluoroscopy time (time frame: during intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.