A Prospective Study on the Association Between Peritumoral Elasticity Measured by Three-Dimensional Magnetic Resonance Elastography and Pathological Resection Margin Status and Postoperative Recurrence in Patients With Liver Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Diagnostic performance of postoperative 3D-MRE for detecting residual tumor at the resection margin
研究概览
简要总结
Microscopic residual tumor at the resection margin is a critical risk factor for recurrence in patients undergoing hepatectomy for liver cancer, yet current detection relies solely on postoperative pathological examination of the resected specimen, which reflects only the removed tissue rather than the actual remnant liver in the patient. How to non-invasively detect residual tumor at the resection margin of the remnant liver after surgery remains an important unresolved problem in the surgical management of liver cancer. We hypothesize that tissue stiffness at the resection margin of the remnant liver, measured by postoperative three-dimensional magnetic resonance elastography (3D-MRE), may reflect microscopic residual tumor and may therefore correlate with pathological resection margin status and be predictive of postoperative tumor recurrence. This study aims to prospectively evaluate the diagnostic performance of postoperative 3D-MRE in detecting residual tumor at the resection margin, using pathological resection margin status as the reference standard, and to further assess its value in predicting tumor recurrence in patients undergoing hepatectomy for liver cancer.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Pathologically confirmed diagnosis of hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or liver metastasis (e.g., from colorectal cancer)
- •Underwent curative-intent hepatectomy with available postoperative pathological resection margin assessment
- •Child-Pugh class A or B liver function (for patients with primary liver cancer)
- •Able to undergo 3D-MRE examination at postoperative day 7-14
- •Provision of signed and dated informed consent
排除标准
- •Contraindication to MRI (e.g., non-MRI-compatible implants, severe claustrophobia)
- •Palliative or non-curative surgery (R2 resection)
- •Presence of unresectable extrahepatic disease at the time of surgery
- •Reoperation or unplanned return to surgery within 14 days after the initial hepatectomy
- •Severe postoperative complications precluding MRI examination at postoperative day 7-14 (e.g., unstable vital signs, need for intensive care)
- •Death within 14 days after surgery from non-tumor-related causes
- •Prior history of liver resection or liver transplantation
- •Pregnant or breastfeeding women
- •Anticipated poor compliance with postoperative MRE examination or follow-up
结局指标
主要结局
Diagnostic performance of postoperative 3D-MRE for detecting residual tumor at the resection margin
时间窗: Postoperative day 7-14
Sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) of 3D-MRE-derived stiffness parameters at the resection margin of the remnant liver, compared with pathological resection margin status (R0 vs. R1) of the surgical specimen as the reference standard.
次要结局
- Recurrence-Free Survival (RFS)(Up to 2 years after surgery)
- Overall Survival (OS)(Up to 2 years after surgery)
- Correlation between 3D-MRE parameters at the resection margin and time to recurrence(Postoperative day 7-14 (MRE); up to 2 years (recurrence follow-up))
- Recurrence pattern (local vs. distant intrahepatic vs. extrahepatic)(Up to 2 years after surgery)