NCT07727759Recruiting
CT Volumetry and Hepatic Vascular Deformation Mapping to Predict Post-Hepatectomy Liver Failure
Beyond Size - Integrating CT Volumetry With Hepatic Vascular Deformation Mapping to Anticipate Post-Resection Congestion and Liver Failure
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
Removing a large part of the liver (major hepatectomy) can cure primary and secondary liver cancers, but it carries the risk of post-hepatectomy liver failure (PHLF), a serious complication in which the liver left behind - the future liver remnant (FLR) - cannot meet the body's metabolic needs. PHLF occurs after roughly 5% to 15% of major hepatectomies and is the leading cause of postoperative death. Before surgery, surgeons routinely use CT scans to measure how much liver will remain (CT volumetry). Volume alone does not tell the whole story. After a large resection the remaining liver can rotate and shift into the empty space left behind, kinking or compressing the veins that drain it. The resulting congestion can make an apparently adequate remnant fail. This prospective, multicenter, observational cohort study tests whether adding two elements to standard CT volumetry improves the preoperative prediction of liver failure: 1. Hepatic vascular deformation mapping (VDM), a three-dimensional image-analysis technique that quantifies the geometry and displacement of the hepatic veins and the portal vein; and 2. A set of simple, reproducible measurements that any radiologist can make on a standard CT scan (hepatic vein diameters, congestion index, spleen volume, liver attenuation, and the distances from the veins to the planned resection plane). Consecutive adults undergoing major hepatic resection (three or more Couinaud segments) at several tertiary hepatobiliary centers will be enrolled. The preoperative CT scans already performed as part of routine care are analyzed centrally by a core imaging laboratory. There is no additional imaging, no extra hospital visit, and no study-specific intervention: every patient receives standard surgical care. Participants are followed for at least 30 days after surgery to record liver failure (International Study Group of Liver Surgery criteria, operationalized by the "50-50" rule on postoperative day 5) and radiologic evidence of hepatic congestion. Three nested prediction models are compared - volumetry alone; volumetry plus VDM; and volumetry plus VDM plus the simple radiology parameters - and the best-performing model is converted into a practical risk score. Because the study runs across several centers, the model can be validated by leaving one center out at a time, which gives an honest estimate of how well it would perform at a new hospital. The goal is a generalizable, easy-to-use tool that tells surgeons, before the operation, which patients are genuinely at risk of post-hepatectomy liver failure.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1070 (estimated)
- First submitted
- 16 Jul 2026
- Start date
- 15 Aug 2026
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Minia University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07727759
What you commit to
- Study type: Observational
- Planned participants: 1070
- From 15 Aug 2026 to the primary completion date, 30 Apr 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Minor hepatic resection (fewer than three Couinaud segments)
- Emergency hepatic resection for trauma
Other illness
- Significant pre-existing vascular anomaly or vascular pathology (for example, portal vein thrombosis)
Other
- Preoperative imaging that fails central quality control
- Incomplete follow-up data
Who the study is looking for
- Age 18 years or older
- Scheduled to undergo major hepatic resection, defined as the removal of three or more Couinaud segments, at a participating center
- Availability of a preoperative multiphasic contrast-enhanced CT of the liver of quality sufficient for central core-laboratory analysis
- Willing and able to complete postoperative clinical and laboratory follow-up for at least 30 days
- Written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maadi Armed Forces Medical Compound - Department of Liver and Pancreas Surgery and Liver Transplantation Coordinator of this site? Confirm its status | Maadi | Egypt | Recruiting |
| Liver and GIT Hospital, Faculty of Medicine, Minia University Coordinator of this site? Confirm its status | Minya | Egypt | Recruiting |
| National Liver Institute, Menoufia University Coordinator of this site? Confirm its status | Shibīn al Kawm | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.