ARAPS Study on Accelerated Liver Regeneration
ARAPS
ARAPS Study: Comparison of Portal Vein Embolization With Radiofrequency Ablation Versus Portal Vein Embolization Alone for Accelerated Liver Regeneration: A Randomized Controlled Trial
1 other identifier
interventional
30
1 country
1
Brief Summary
Liver resection is the golden standard in the treatment of hepatic malignancies. The size and function of the remnant liver is a major concern. If the future liver remnant (FLR) is below 30 % of the initial liver volume, the risk of post hepatectomy liver insufficiency rises. Several techniques have been developed to increase the size of FLR before liver resection. In this study a new technique ARAPS (portal vein embolization with radio frequency ablation) is compared to portal vein embolization alone for accelerated liver growth in the FLR. This is done in a randomized controlled trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2019
CompletedFirst Posted
Study publicly available on registry
September 27, 2019
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedJanuary 15, 2021
November 1, 2020
2.8 years
September 20, 2019
January 12, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
Liver volume
Growth in FLR volume (ml/day)
7 days
Liver volume
Growth in FLR volume (ml/day)
14 days
Liver Function
FDGal-PET to quantify whole-liver and FLR hepatic metabolic function. The standardized uptake value SUV (unit-less) is calculated for whole liver and FLR.
7 days
Liver Function
FDGal-PET to quantify whole-liver and FLR hepatic metabolic function. The standardized uptake value SUV (unit-less) is calculated for whole liver and FLR.
14 days
Secondary Outcomes (1)
Resection rate
within 12 weeks
Study Arms (2)
PVE (Portal vein embolisation)
OTHERStandard of care when FLR is small.
ARAPS (Portal vein embolisation and associating RFA)
EXPERIMENTALExperimental arm with PVE combined with RFA to induce accelerated liver hypertrophy.
Interventions
In a previous experimental study on rats, the investigators have shown that PVE combined with radiofrequency ablation (RFA), hereafter called Associated Radiofrequency Ablation and Portal Vein Ligation for Staged Hepatectomy (ARAPS), can induce accelerated growth of the FLR
Eligibility Criteria
You may qualify if:
- Patients with Colorectal liver metastasis; initially considered unresectable or borderline resectable due to an expected postoperative FLR volume of \<30 %
You may not qualify if:
- Liver cirrhosis
- Significant comorbidity rendering subjects unsuitable for major surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Rigshospitalet, Denmarkcollaborator
Study Sites (1)
Aarhus University Hospital
Aarhus, 8200, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2019
First Posted
September 27, 2019
Study Start
January 1, 2020
Primary Completion
November 1, 2022
Study Completion
May 1, 2023
Last Updated
January 15, 2021
Record last verified: 2020-11