Quantitative MRI and Outcomes of Liver Resection (NCT06181318) | Clinical Trial Compass
UnknownNot Applicable
Quantitative MRI and Outcomes of Liver Resection
33 participantsStarted 2024-02-01
Plain-language summary
The present observational study aims to assess the benefit of this quantitative multiparametric magnetic resonance imaging (MRI) in clinical practice, to quantify future liver remnant performance, and to accurately predict the risk of liver failure after major hepatectomy, among patients undergoing major liver resection.
The main questions to be answered are:
* Can multiparametric MRI predict the postoperative liver function?
* Can multiparametric MRI predict the postoperative liver-specific complications as well as mortality? With ethical approval and fully informed consent, patients being considered for major liver resection will undergo clinical assessment, blood sampling, and multiparametric MRI before surgery. For the primary outcome, 33 participants will be needed to detect a minimum correlation coefficient of 0.2 with 5% significance and 80% power.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult (≥ 18 years old) patients with an indication for elective major liver resection.
* Any benign or malignant indication.
* Provision of informed consent.
* MRI scan performed ≤ 7 days before surgery
Exclusion Criteria:
* Previous liver resection.
* Previous volume-enhancing procedures, such as portal vein embolization.
* Previous microwave ablation of liver lesions.
* Contraindication and/or inability to undergo contrast-enhanced MRI scan (including implanted metallic devices or foreign bodies, claustrophobia and contraindication for Primovist® administration).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is focused on using MRI scans to predict serious complications after major liver surgery — like liver failure, bile leaks, and bleeding — so would participating in this trial give me any extra imaging or information that could actually help guide decisions about my own surgery?
2Since this trial's recruitment status is listed as unknown, can you find out whether it's still actively enrolling patients and whether this hospital or a nearby center is involved?
3If the goal is to use MRI measurements to predict complications after liver resection, does that mean I'd be undergoing additional MRI scans beyond what's already planned for my care, and what would that involve in terms of time and scheduling?
4Given that this appears to be an observational study to predict surgical risks rather than a study testing a new treatment, what does my current liver function or imaging already tell you about my personal risk of complications like post-surgery liver failure or a bile leak?
5If this trial is mainly about collecting data to improve future predictions, would joining it change anything about how my surgery or recovery is actually managed, or would my treatment plan stay exactly the same regardless of whether I enroll?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Predicting the posthepatectomy liver failure after major liver resection
Timeframe: 90 days postoperative
2
Predicting the posthepatectomy biliary leakage after major liver resection
Timeframe: 90 days postoperative
3
Predicting the posthepatectomy hemorrhage after major liver resection