Hepatic NeoplasmNCT04182386
Scandinavian Cohort Study for Optimal Use of Portal Vein Embolization
An observational study of Hepatic Neoplasm, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Several aspects on the use of portal vein embolization (PVE) are poorly studied and todays recommendations are based on low-grade evidence. In this Scandinavian multicenter cohort study we will study some of the controversial aspects on the use of PVE to try to provide clearer answers on its optimal use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Neoplasm
- What is being tested?
- Portal vein embolization
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2012to 31 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: Scandinavian patients subjected to PVE at 6 hepatobiliary centers during the study period.
Who may be able to join
- Right-sided PVE
Who cannot join
- Left-sided PVE
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm
Ernesto Sparrelid, MD PhD, ernesto.sparrelid@ki.se
About this study
Several aspects on the use of portal vein embolization (PVE) are poorly studied and todays recommendations are based on low-grade evidence. In this Scandinavian multicenter cohort study we will study some of the controversial aspects on the use of PVE to try to provide clearer answers on its optimal use. Six tertiary university hospital hepatobiliary units in Sweden, Norway and Denmark participate and contribute with all PVE procedures performed at their units during the study period. We will then study several aspects PVE technique in relation to induced hypertrophy and surgical outcome.
- Conditions
- Hepatic Neoplasm
- Being tested
- Portal vein embolization
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portal vein embolizationProcedure or surgery
Selective preoperative portal vein embolization
| Study group | Role | What they receive |
|---|---|---|
| rPVE | Right portal vein embolization. All patients subjected to selective right portal vein embolization prior to planned hepatobiliary surgery. Receives: Procedure: Portal vein embolization | |
| rPVE+S4 | Right portal vein embolization including segment 4 portal vein branches. All patients subjected to selective right portal vein embolization including segment 4 portal vein branches prior to planned hepatobiliary surgery. Receives: Procedure: Portal vein embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Future liver remnant hypertrophy
Increase in future liver remnant, (%)
Measured: Based on radiology around 4 weeks before and after intervention
Secondary outcomes (3)
Effect of segment 4 embolization on hypertrophy
Increase in future liver remnant (%) dependeing on if segment 4 is embolized or not.
Measured: Based on radiology around 4 weeks before and after intervention
Effect of hyperbilirubinemia on hypertrophy
Increase in future liver remnant (%) dependeing on the levels of bilirubin before portal vein embolization.
Measured: Based on radiology around 4 weeks before and after intervention
Effect of sarcopenia on hypertrophy
Increase in future liver remnant (%) dependeing on the level of sarcopenia before portal vein embolization.
Measured: Based on radiology around 4 weeks before and after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start1 Aug 2012
- Primary completion31 Dec 2021
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic NeoplasmStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ernesto Sparrelid, Karolinska University Hospital
- Investigators
- Ernesto Sparrelid, MD PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182386
- Sponsor's protocol ID
- Scandinavian PVE study
- Status last verified
- Mar 2022
- First submitted
- 22 Nov 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available to other researchers on demand.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scandinavian Cohort Study for Optimal Use of Portal Vein Embolization
- ClinicalTrials.gov ID
- NCT04182386
- Acronym / sponsor ID
- Scandinavian PVE study
- Conditions
- Hepatic Neoplasm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 Dec 2019 (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.
Several aspects on the use of portal vein embolization (PVE) are poorly studied and todays recommendations are based on low-grade evidence. In this Scandinavian multicenter cohort study we will study some of the controversial aspects on the use of PVE to try to provide clearer answers on its optimal use. Six tertiary university hospital hepatobiliary units in Sweden, Norway and Denmark participate and contribute with all PVE procedures performed at their units during the study period. We will then study several aspects PVE technique in relation to induced hypertrophy and surgical outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rPVE | – | Procedure: Portal vein embolizationRight portal vein embolization. All patients subjected to selective right portal vein embolization prior to planned hepatobiliary surgery. |
| rPVE+S4 | – | Procedure: Portal vein embolizationRight portal vein embolization including segment 4 portal vein branches. All patients subjected to selective right portal vein embolization including segment 4 portal vein branches prior to planned hepatobiliary surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Scandinavian patients subjected to PVE at 6 hepatobiliary centers during the study period.
Key inclusion criteria (1 listed)
- Right-sided PVE
Key exclusion criteria (1 listed)
- Left-sided PVE
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 embolizationSelective preoperative portal vein embolization | Procedure or surgery | rPVE, rPVE+S4 |
Primary outcome
Future liver remnant hypertrophy
Time frame: Based on radiology around 4 weeks before and after intervention
Increase in future liver remnant, (%)
3 secondary outcomes
Effect of segment 4 embolization on hypertrophy
Time frame: Based on radiology around 4 weeks before and after intervention
Effect of hyperbilirubinemia on hypertrophy
Time frame: Based on radiology around 4 weeks before and after intervention
Effect of sarcopenia on hypertrophy
Time frame: Based on radiology around 4 weeks before and after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Yes. Data will be made available to other researchers on demand.
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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.
Ernesto Sparrelid, MD PhD principal investigator
Karolinska University Hospital
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 Hepatic Neoplasm, run by Karolinska University Hospital 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 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: status not confirmed, as of the sponsor's last update on 31 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ernesto Sparrelid, MD PhD (+46-708-880787, ernesto.sparrelid@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Future liver remnant hypertrophy (time frame: Based on radiology around 4 weeks before and after 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 31 Mar 2022.