Peritumoral MRE Stiffness for Predicting Resection Margin Status and Recurrence in Liver Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorSecond Affiliated Hospital of Xi'an Jiaotong University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Three-Dimensional Magnetic Resonance Elastography

    Device

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Postoperative day 7-14

Secondary outcomes

1

Recurrence-Free Survival (RFS)

Time from surgery to radiologically or pathologically confirmed tumor recurrence, or last follow-up if no recurrence occurs

Time frame
Up to 2 years after surgery
2

Overall Survival (OS)

Time from surgery to death from any cause

Time frame
Up to 2 years after surgery
3

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

Time frame
Postoperative day 7-14 (MRE); up to 2 years (recurrence follow-up)
4

Recurrence pattern (local vs. distant intrahepatic vs. extrahepatic)

Classification of recurrence site and pattern based on imaging follow-up

Time frame
Up to 2 years after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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