Hepato Cellular Carcinoma, Intrahepatic Bile Duct Carcinoma, Metastatic Hepatocellular Carcinoma
Conditions
Brief summary
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.
Interventions
Patients undergoing hepatectomy for liver cancer will undergo a postoperative three-dimensional magnetic resonance elastography (3D-MRE) examination of the remnant liver in addition to standard-of-care postoperative evaluation. 3D-MRE will be used to measure tissue stiffness and viscoelastic parameters at the resection margin of the remnant liver. These imaging findings will be compared with the pathological resection margin status (R0/R1) of the surgical specimen, which serves as the reference standard, to evaluate the diagnostic performance of 3D-MRE in detecting residual tumor at the resection margin. Patients will subsequently be followed to assess the association between 3D-MRE findings and postoperative tumor recurrence. The examination does not alter the standard postoperative management or treatment decisions.
Sponsors
Second Affiliated Hospital of Xi'an Jiaotong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance of postoperative 3D-MRE for detecting residual tumor at the resection margin | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-Free Survival (RFS) | Up to 2 years after surgery | Time from surgery to radiologically or pathologically confirmed tumor recurrence, or last follow-up if no recurrence occurs |
| Overall Survival (OS) | Up to 2 years after surgery | Time from surgery to death from any cause |
| 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) | Association between quantitative 3D-MRE parameters (e.g., stiffness, damping ratio) measured at postoperative day 7-14 and subsequent time to tumor recurrence |
| Recurrence pattern (local vs. distant intrahepatic vs. extrahepatic) | Up to 2 years after surgery | Classification of recurrence site and pattern based on imaging follow-up |
Contacts
CONTACTKai Qu
Outcome results
None listed