Beyond Size - Integrating CT Volumetry With Hepatic Vascular Deformation Mapping to Anticipate Post-Resection Congestion and Liver Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,070
- 试验地点
- 6
- 主要终点
- 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)
研究概览
简要总结
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:
- 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
- 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.
详细描述
BACKGROUND AND RATIONALE Major hepatic resection is the only potentially curative treatment for many primary and secondary liver malignancies. Post-hepatectomy liver failure (PHLF) remains the most feared complication and the leading cause of postoperative mortality, occurring in approximately 5% to 15% of patients after major hepatectomy. Preoperative risk assessment currently rests on CT volumetry, which quantifies the future liver remnant (FLR) and confirms that sufficient functional hepatic mass will remain. Volumetry is, however, a static measurement: it does not capture the hemodynamic consequences of the resection.
Hepatic venous congestion is an under-recognized contributor to PHLF. When major venous tributaries are sacrificed, or when the residual liver rotates and shifts into the empty subphrenic space after a large resection, the hepatic veins may kink or become compressed, producing outflow obstruction and functional impairment of an FLR that appeared volumetrically adequate. Vascular Deformation Mapping (VDM) is an image-analysis technique that uses deformable registration to quantify three-dimensional changes in vascular geometry, offering a way to identify "at-risk" vascular configurations before the operation.
This study tests the hypothesis that integrating VDM-derived parameters and a set of simple, reproducible radiology parameters with conventional CT volumetry improves the preoperative prediction of PHLF. A multicenter design is essential: it accrues an adequate number of PHLF events for stable multivariable modeling, broadens the case-mix and the range of imaging and surgical practice represented, and permits internal-external cross-validation, which provides an honest estimate of how the model is expected to perform when transported to a new center.
OBJECTIVES Primary objective: to determine whether the integration of CT volumetry with VDM-derived parameters improves the preoperative prediction of PHLF compared with volumetry alone.
Secondary objectives: to correlate VDM and simple radiology parameters with radiologic evidence of postoperative hepatic congestion; to identify simple, clinically applicable radiology parameters suitable for routine use; to develop a practical scoring system for preoperative risk stratification; and to assess the transportability of the resulting model across participating centers by internal-external cross-validation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Preoperative CT volumetry with hepatic vascular deformation mapping (VDM) (Diagnostic Test)
结局指标
主要结局
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)
时间窗: 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)
One value is reported: delta AUC-ROC = AUC-ROC (Model 2) minus AUC-ROC (Model 1), with a 95% confidence interval. Unit of measure: AUC units (dimensionless). AUC-ROC ranges from 0.5 (no discrimination) to 1.0 (perfect discrimination); delta AUC-ROC therefore ranges from -0.5 to +0.5, and a positive value indicates that vascular deformation mapping improves prediction. Measurement tool: two nested mixed-effects logistic regression models, each with center as a random intercept, fitted in the same participants. Model 1 (volumetry) = total liver volume, future liver remnant (FLR) volume, FLR ratio, FLR-to-body-weight ratio, resection volume. Model 2 = Model 1 plus vascular deformation mapping parameters (right, middle and left hepatic vein angle to the IVC, hepatic vein confluence-to-IVC-ostium distance, vascular displacement index, portal vein angulation). Post-hepatectomy liver failure (PHLF) is defined and centrally adjudicated as specified in Outcome Measure 2.
次要结局
- Incidence of post-hepatectomy liver failure (PHLF)(From the day of resection to postoperative day 30)
- Discrimination (AUC-ROC) of the full model: CT volumetry plus VDM plus simple radiology parameters(Through study completion (up to 24 months))
- Calibration of the final prediction model(Through study completion (up to 24 months))
- Incidence of radiologic postoperative hepatic congestion(From the day of resection to postoperative day 30)
- Incidence of transient hepatic attenuation differences (THAD)(From the day of resection to postoperative day 30)
- Participants with ISGLS grade A post-hepatectomy liver failure(From the day of resection to postoperative day 30)
- Practical risk score for preoperative stratification of PHLF risk(Through study completion (up to 24 months))
研究者
Saleh Khairy Saleh MD
Lecturer
Minia University