About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
This study will enroll adult patients with primary or metastatic liver cancer, including hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or liver metastases (e.g., from colorectal cancer), who undergo curative-intent hepatectomy at the Second Affiliated Hospital of Xi'an Jiaotong University. Eligible patients will undergo postoperative 3D-MRE examination of the remnant liver and be followed to assess pathological resection margin status and subsequent tumor recurrence. Patients will be consecutively recruited from the hepatobiliary surgery department of the study center.
Trial design
Cohort
Prospective
Treatments tested in this trial
Three-Dimensional Magnetic Resonance Elastography
DevicePatients 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.
Treatment groups
Trial outcomes
Primary outcomes
Diagnostic performance of postoperative 3D-MRE for detecting residual tumor at the resection margin
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 outcomes
Recurrence-Free Survival (RFS)
Time from surgery to radiologically or pathologically confirmed tumor recurrence, or last follow-up if no recurrence occurs
Overall Survival (OS)
Time from surgery to death from any cause
Correlation between 3D-MRE parameters at the resection margin and time to recurrence
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)
Classification of recurrence site and pattern based on imaging follow-up
Locations
Sponsors and contacts
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