Comparing methods to increase liver size before surgery
Comparison of Three Methods of Inducing Liver Hypertrophy Before Resection - a Randomized Controlled Trial
This study is testing three different ways to help increase liver size before surgery for patients with liver tumors to see which method works best.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Medical University of Warsaw Academic / other |
| Locations | 1 site (Warsaw, Masovian Voivodeship) |
| Trial ID | NCT06050200 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and safety of three different methods to increase the future remnant liver (FRL) size in patients with malignant liver lesions who are candidates for liver resection. The methods being compared are Portal Vein Embolization (PVE), Liver Vein Deprivation (LVD), and partial ALPPS (Associating Liver Partition and Portal vein Ligation for Staged hepatectomy). The study will assess both volumetric increases using computer tomography scans and functional increases through 99mTc-mebrofenin scintigraphy. This is a randomized trial, addressing a gap in previous research that primarily focused on retrospective analyses and volumetric assessments alone.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are eligible for liver resection and have a future remnant liver volume of less than 30% of the standard liver volume.
Not a fit: Patients with liver cirrhosis, pregnancy, poor general health status, or contraindications to iodine contrast agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective approach to preparing patients for liver surgery, potentially improving surgical outcomes.
How similar studies have performed: While previous studies have explored these methods, this is the first randomized trial comparing all three approaches, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \>= 18 years * patients qualified for liver resection * future remnant liver \<30% of standard liver volume * written informed consent Exclusion Criteria: * liver cirrhosis * pregnancy * poor general health status or comorbidities excluding general anesthesia or hepatic resection * contraindications to iodine contrast agents
Where this trial is running
Warsaw, Masovian Voivodeship
- Second Department of Clinical Radiology — Warsaw, Masovian Voivodeship, Poland (Recruiting)
Study contacts
- Principal investigator: Karolina Grąt, PhD — Medical University of Warsaw
- Study coordinator: Karolina Grąt, PhD
- Email: karolina.grat@wum.edu.pl
- Phone: +48225992300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.