Predicting liver failure risk using preoperative MRI
Is It Possible To Predict PHLF? - Retrospective Analysis of Gadoxetate MRI Prior To Major Liver Resection
This study is testing if a special MRI scan can help doctors predict the risk of liver failure after surgery in patients having their liver removed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Linkoeping Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Copenhagen and 6 other locations) |
| Trial ID | NCT04692259 on ClinicalTrials.gov |
What this trial studies
This study evaluates the potential of preoperative MRI with Gadoxetate to predict the risk of post hepatectomy liver failure (PHLF) in patients undergoing liver resection. It aims to address the challenges in assessing liver function prior to surgery, as current methods are often imprecise. By analyzing data from patients who have undergone MRI scans before their surgeries, the study seeks to correlate MRI findings with postoperative outcomes. The goal is to improve preoperative evaluations and potentially reduce the incidence of PHLF.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for liver resection who have undergone a Primovist MRI within the specified time frame.
Not a fit: Patients under 18 years old or those for whom liver resection was not performed will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better preoperative assessments and reduced rates of liver failure after surgery.
How similar studies have performed: While the use of MRI in liver assessments is established, this specific predictive approach using Gadoxetate is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who have had a Primovist MRI within 8 weeks before hemihepatectomy or extended hemi-hepatectomy +/- bile duct anastomosis independent of diagnosis. 2. Patients with cirrhosis who have had a Primovist MRI within 8 weeks before resection of more than one liver segment 3. Patients who had liver volume augmentation with a pre-operative Primovist MRI less than 2 weeks before resection 4. Patients who have had a Primovist MRI within 6 weeks be-fore any liver resection where PHLF or death within 90 days occurred. - Exclusion Criteria: 1. \<18 years of age 2. Resection was not performed -
Where this trial is running
Copenhagen and 6 other locations
- Rikshospitalet — Copenhagen, Denmark (Recruiting)
- Helsingfors Universitetssjukhus — Helsinki, Finland (Recruiting)
- Rikshospitalet — Oslo, Norway (Recruiting)
- Per Sandström — Linköping, Ostergotland, Sweden (Recruiting)
- Karolinska Universitetssjukhuset Huddinge — Stockholm, Södermanland, Sweden (Recruiting)
- Sahlgrenska sjukhuset — Göteborg, Sweden (Recruiting)
- Akademiska sjukhuset — Uppsala, Sweden (Recruiting)
Study contacts
- Principal investigator: Per Sandström, Prof — Academic study
- Study coordinator: Per Sandström, Prof
- Email: per.sandstrom@liu.se
- Phone: +46734058581
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.