Portal Vein Embolization, Liver, HypertrophyNCT05660759
Comparison of N-butyl-cyanoacrylate and Micro Parti-cles Effect in Inducing Liver Hypertrophy After PVE
An observational study of Portal Vein Embolization, Liver, Hypertrophy, run by Linkoeping University at 1 site in Sweden.
Trial summary
The aim of this study is to compare hypertrophy of the FLR after PVE with microparticles to hypertrophy after PVE with cyanoacrylate in a material large enough to answer the study question. In addition, other factors that may influence the degree of hypertrophy will be evaluated in a multivariable analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portal Vein Embolization, Liver, Hypertrophy
- What is being tested?
- Portal vein embolization
- Type of treatment
- Surgery or procedure
- How many people
- 265 participants
- Where
- 1 siteSweden
- Study dates
- 13 Dec 2022to 13 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing portal vein embolization during the study period 2013 - 2021 in Linköping University Hospital, Karolinska Comprehensive Cancer Center and Skåne University Hospital Lund.
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: N-butyl-cyanoacrylate Glue Versus Micro Particles and the Effect on Inducing Liver Hypertrophy After Portal Vein Embolization- a Retrospective Swedish Multicenter Study
The aim of this study is to compare hypertrophy of the FLR after PVE with microparticles to hypertrophy after PVE with cyanoacrylate in a material large enough to answer the study question. In addition, other factors that may influence the degree of hypertrophy will be evaluated in a multivariable analysis.
The hypothesis is: PVE with cyanoacrylate is superior to PVE with microparticles in terms of FLR hy-pertrophy.
Read the detailed description
With expansion of indications for major liver surgery, portal vein embolization (PVE) is increasingly used in order to induce hypertrophy of the future liver remnant (FLR). De-spite vide variety of materials available to occlude the portal veins the most commonly used are cyanoacrylate and microparticles/spheres. Earlier studies have failed to show superiority of one over the other in terms of hypertrophy of the FLR while PVE with cy-anoacrylate seems to be less time consuming. Two small previous studies from single centers have shown greater growth by cyanoacrylate compared to particles (1) with 90 included patients and the second study with 34 included patients (2), but larger reviews have failed (3). Cyanoacrylate might give a more robust FLR hypertrophy (4) . The main problem in evaluating previous studies has been the large heterogeneity and the often poorly described study populations.
- Being tested
- Portal vein embolization
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portal vein embolizationProcedure or surgery
Portal vein emboliazation with either NBCA or micro particles.
| Study group | Role | What they receive |
|---|---|---|
| NBCA | Patients that recieved portal vein embolization with n-butyl-cyanoacrylate glue. Receives: Procedure: Portal vein embolization | |
| Particles | Patients that recieved portal vein embolization with micro particles. Receives: Procedure: Portal vein embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLR hypertrophy
Measured: Spring 2023
Secondary outcomes (2)
Degree of hypertrophy
Measured: Spring 2023
Kinetic growth rate
Measured: Spring 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start13 Dec 2022
- Primary completion13 Dec 2022
- Study completion13 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal Vein Embolization, Liver, HypertrophyStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet, Skane University Hospital
- Responsible party
- Principal investigator, Bergthor Björnsson, Linkoeping University
- Investigators
- Bergthor Björnsson, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660759
- Sponsor's protocol ID
- DB_01
- Status last verified
- Dec 2022
- First submitted
- 13 Dec 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-butyl-cyanoacrylate Glue Versus Micro Particles and the Effect on Inducing Liver Hypertrophy After Portal Vein Embolization- a Retrospective Swedish Multicenter Study
- ClinicalTrials.gov ID
- NCT05660759
- Acronym / sponsor ID
- DB_01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Karolinska Institutet, Skane University Hospital
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 21 Dec 2022 (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 aim of this study is to compare hypertrophy of the FLR after PVE with microparticles to hypertrophy after PVE with cyanoacrylate in a material large enough to answer the study question. In addition, other factors that may influence the degree of hypertrophy will be evaluated in a multivariable analysis.
The hypothesis is: PVE with cyanoacrylate is superior to PVE with microparticles in terms of FLR hy-pertrophy.
Detailed description
With expansion of indications for major liver surgery, portal vein embolization (PVE) is increasingly used in order to induce hypertrophy of the future liver remnant (FLR). De-spite vide variety of materials available to occlude the portal veins the most commonly used are cyanoacrylate and microparticles/spheres. Earlier studies have failed to show superiority of one over the other in terms of hypertrophy of the FLR while PVE with cy-anoacrylate seems to be less time consuming. Two small previous studies from single centers have shown greater growth by cyanoacrylate compared to particles (1) with 90 included patients and the second study with 34 included patients (2), but larger reviews have failed (3). Cyanoacrylate might give a more robust FLR hypertrophy (4) . The main problem in evaluating previous studies has been the large heterogeneity and the often poorly described study populations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NBCA | – | Procedure: Portal vein embolizationPatients that recieved portal vein embolization with n-butyl-cyanoacrylate glue. |
| Particles | – | Procedure: Portal vein embolizationPatients that recieved portal vein embolization with micro particles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing portal vein embolization during the study period 2013 - 2021 in Linköping University Hospital, Karolinska Comprehensive Cancer Center and Skåne University Hospital Lund.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Portal vein embolizationPortal vein emboliazation with either NBCA or micro particles. | Procedure or surgery | NBCA, Particles |
Primary outcome
FLR hypertrophy
Time frame: Spring 2023
2 secondary outcomes
Degree of hypertrophy
Time frame: Spring 2023
Kinetic growth rate
Time frame: Spring 2023
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 21 Dec 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Portal Vein Embolization, Liver, Hypertrophy
Recruiting
TANGO-LIVER Three Arm Nuclear Growth Observation in Liver Surgery
Liver Metastases, Liver Cancer
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.
Bergthor Björnsson, PhD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Vein Embolization, Liver, Hypertrophy, run by Linkoeping University at 1 site in Sweden.
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 0 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 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
FLR hypertrophy (time frame: Spring 2023). 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 21 Dec 2022.