Hepatectomy Clinical Trials

Clinical trials related to Hepatectomy Procedure

Beyond Size - Integrating CT Volumetry With Hepatic Vascular Deformation Mapping to Anticipate Post-Resection Congestion and Liver Failure

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Egypt
Maadi Armed Forces Medical Compound - Department of Liver and Pancreas Surgery and Liver Transplantation
RECRUITING
Maadi
Liver and GIT Hospital, Faculty of Medicine, Minia University
RECRUITING
Minya
National Liver Institute, Menoufia University
RECRUITING
Shibīn Al Kawm
Contact Information
Primary
Saleh K Saleh, MD
salehkhairy@mu.edu.eg
01201765401
Time Frame
Start Date: 2026-08-15
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 1070
Treatments
Major hepatic resection cohort
Preoperative CT volumetry with hepatic vascular deformation mapping (VDM) Consecutive adults (18 years or older) undergoing elective major hepatic resection (three or more Couinaud segments) for benign or malignant liver disease at a participating tertiary hepatobiliary center, with a preoperative multiphasic contrast-enhanced CT of quality sufficient for central core-laboratory analysis. All participants receive standard-of-care surgical management. The exposures of interest are the preoperative imaging phenotypes - CT volumetry, hepatic vascular deformation mapping, and simple radiology parameters - derived centrally from the routinely acquired preoperative CT. Participants are classified after surgery according to whether or not they develop post-hepatectomy liver failure.
Related Therapeutic Areas
Sponsors
Collaborators: National Liver Institute, Egypt, Maadi Armed Forces Medical Compound, Ministry of Defence
Leads: Minia University

This content was sourced from clinicaltrials.gov