Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatic Congestion | — | UNRESOLVED | — |
| Liver Failure | — | UNRESOLVED | — |
| Liver Metastases | — | UNRESOLVED | — |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Post-Hepatectomy Liver Failure | — | UNRESOLVED | — |
| Postoperative Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preoperative CT volumetry with hepatic vascular deformation mapping (VDM) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Major hepatic resection cohort
- description
- 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.
- interventionNames
- Diagnostic Test: Preoperative CT volumetry with hepatic vascular deformation mapping (VDM)
Primary outcomes (1)
- measure
- Change in discrimination (delta AUC-ROC) for preoperative prediction of post-hepatectomy liver failure: CT volumetry plus vascular deformation mapping (Model 2) minus CT volumetry alone (Model 1)
- timeFrame
- PHLF is ascertained in each participant from the day of resection to postoperative day 30; the two models are compared after the last enrolled participant completes 30-day follow-up (through study completion, up to 24 months)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Minor hepatic resection (fewer than three Couinaud segments) * Significant pre-existing vascular anomaly or vascular pathology (for example, portal vein thrombosis) * Emergency hepatic resection for trauma * Preoperative imaging that fails central quality control * Incomplete follow-up data
References
Publications (6)
- BACKGROUNDRahbari NN, Garden OJ, Padbury R, Brooke-Smith M, Crawford M, Adam R, Koch M, Makuuchi M, Dematteo RP, Christophi C, Banting S, Usatoff V, Nagino M, Maddern G, Hugh TJ, Vauthey JN, Greig P, Rees M, Yokoyama Y, Fan ST, Nimura Y, Figueras J, Capussotti L, Buchler MW, Weitz J. Posthepatectomy liver failure: a definition and grading by the International Study Group of Liver Surgery (ISGLS). Surgery. 2011 May;149(5):713-24. doi: 10.1016/j.surg.2010.10.001. Epub 2011 Jan 14. PMID 21236455
- BACKGROUNDVauthey JN, Chaoui A, Do KA, Bilimoria MM, Fenstermacher MJ, Charnsangavej C, Hicks M, Alsfasser G, Lauwers G, Hawkins IF, Caridi J. Standardized measurement of the future liver remnant prior to extended liver resection: methodology and clinical associations. Surgery. 2000 May;127(5):512-9. doi: 10.1067/msy.2000.105294. PMID 10819059
- BACKGROUNDKanno H, Yoshida A, Goto Y, Hisaka T, Akagi Y, Okuda K. A case of hepatic venous outflow obstruction caused by migration of the remnant liver into the subphrenic space after extended posterior sectionectomy of the liver. Int J Surg Case Rep. 2020;76:297-300. doi: 10.1016/j.ijscr.2020.09.203. Epub 2020 Oct 6. PMID 33065490
- BACKGROUNDMoriyasu F, Nishida O, Ban N, Nakamura T, Sakai M, Miyake T, Uchino H. "Congestion index" of the portal vein. AJR Am J Roentgenol. 1986 Apr;146(4):735-9. doi: 10.2214/ajr.146.4.735. PMID 3485345
- BACKGROUNDKutaiba N, Chung W, Goodwin M, Testro A, Egan G, Lim R. The impact of hepatic and splenic volumetric assessment in imaging for chronic liver disease: a narrative review. Insights Imaging. 2024 Jun 18;15(1):146. doi: 10.1186/s13244-024-01727-3. PMID 38886297
- BACKGROUNDBalzan S, Belghiti J, Farges O, Ogata S, Sauvanet A, Delefosse D, Durand F. The "50-50 criteria" on postoperative day 5: an accurate predictor of liver failure and death after hepatectomy. Ann Surg. 2005 Dec;242(6):824-8, discussion 828-9. doi: 10.1097/01.sla.0000189131.90876.9e.