N/A
N=57
Regeneration of Liver: Portal Vein Embolization Versus Radiofrequency Assisted Ligation for Liver Hypertrophy (REBIRTH)
Liver Resection · Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02216773 ↗Enrolled (actual)
57
Serious AEs
10.0%
Results posted
Nov 2019
Primary outcome: Primary: Changes in Liver Remnant Volume — 18.4; 80.7 percentage change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiofrequency assisted liver partition with portal vein ligation (RALPP) (Procedure); Portal vein embolization (PVE) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Liver Remnant Volume |
18.4; 80.7 | — |
| SECONDARY Postoperative Liver Function Tests |
— | — |
| SECONDARY Number of Participants With Postoperative Complications (Dindo Clavien ≥Grade 3b) |
1; 4 | — |
Summary
The aim of this study is to compare two different techniques (portal vein embolization and radiofrequency assisted liver partition with portal vein ligation) for increasing liver volume prior to major liver resection.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years
- Any patient requiring right or extended right hepatectomy with FLRV less than 25% on preoperative volumetric study
- WHO performance status 0, 1 or 2
- Patient able to comply with protocol requirements and deemed fit for surgical resection
- Written informed consent
Exclusion Criteria
- Inability to give informed consent
- Pregnancy
- WHO status 3 or 4
- New York Heart Association Classification Grade III or IV
Data sourced from ClinicalTrials.gov (NCT02216773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.