Scandinavian Cohort Study for Optimal Use of Portal Vein Embolization

Hepatic Neoplasm Clinical Trial

Official title:

Scandinavian Cohort Study for Optimal Use of Portal Vein Embolization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04182386
• Other study ID #: Scandinavian PVE study
• Status: Recruiting
• Start date: August 1, 2012
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Karolinska University Hospital
• Contact: Ernesto Sparrelid, MD PhD
• Phone: +46-708-880787
• Email: ernesto.sparrelid[@]ki.se
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Right-sided PVE

Exclusion Criteria:

• Left-sided PVE

Related Conditions & MeSH terms

• Hepatic Neoplasm
• Liver Neoplasms

Intervention

Procedure:
• Portal vein embolization
Selective preoperative portal vein embolization

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Future liver remnant hypertrophy	Increase in future liver remnant, (%)	Based on radiology around 4 weeks before and after intervention
Secondary	Effect of segment 4 embolization on hypertrophy	Increase in future liver remnant (%) dependeing on if segment 4 is embolized or not.	Based on radiology around 4 weeks before and after intervention
Secondary	Effect of hyperbilirubinemia on hypertrophy	Increase in future liver remnant (%) dependeing on the levels of bilirubin before portal vein embolization.	Based on radiology around 4 weeks before and after intervention
Secondary	Effect of sarcopenia on hypertrophy	Increase in future liver remnant (%) dependeing on the level of sarcopenia before portal vein embolization.	Based on radiology around 4 weeks before and after intervention