Effect of Surgical Margin Width on Recurrence and Survival in Patients With Hepatic Oligometastasis of Colorectal Cancer

Launched by FUDAN UNIVERSITY · Apr 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how the width of surgical margins—meaning the distance between the edge of the removed tumor and healthy tissue—affects outcomes for patients with liver tumors caused by colorectal cancer. Researchers want to find out if having a wider margin (at least 7mm) compared to a narrower margin (less than 7mm) can lead to better chances of staying cancer-free for a year and improving overall survival. The study will also look at the safety of these surgical approaches during the recovery period.

To be eligible for the trial, participants must be at least 18 years old and have a confirmed diagnosis of colorectal cancer that has spread to the liver. They should have no more than five liver tumors and no other untreated cancer elsewhere in the body. Participants will undergo surgery to remove the tumors and will be randomly assigned to either the wide margin or narrow margin group. Throughout the study, they can expect regular follow-ups to monitor their health and recovery. It’s important to note that individuals with certain health conditions or complications may not qualify for the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female patients, age ≥18 years;
• • ECOG Physical condition score :0-1 score;
• • Liver biopsy pathologic diagnosis or clinical history combined with laboratory examination and imaging findings can be used to diagnose colorectal cancer in liver;
• • The primary lesion of colorectal cancer has been resected or can be resected 4-6 weeks after hepatectomy;
• • The number of liver metastases was less than or equal to 5；
• • There was no extrahepatic metastases or the metastases were radically resected；
• • Preoperative assessment (based on enhanced CT or MRI image AI segmentation combined with three-dimensional reconstruction of hepatic parenchymal blood vessels) enables radical (R0) resection of hepatic oligometastases, and wide surgical margin (the narrowest incisal margin of fresh specimens surgically removed is greater than or equal to 7mm) can be achieved technically, and the incisal margin width is not affected by the intrahepatic vasculature；
• • Good liver reserve function (preoperative Child-Pugh grade A liver function, estimated remaining liver volume ≥30%)；
• • Preoperative examinations do not show clear surgical contraindications；
• • Volunteer to participate in this study and sign the informed consent；
• • The compliance was good, and the family members were willing to cooperate with the follow-up；
• Exclusion Criteria:
• • There are still untreated extra-hepatic metastases；
• • Staging hepatectomy is planned, such as PVE combined with hepatectomy, ALPPS, etc；
• • The number of liver metastases before chemotherapy was more than 5；
• • Complicated with portal vein tumor thrombus or hepatic vein invasion；
• • Concurrent with other uncured malignancies or with other primary malignancies for less than 5 years；
• • Expected survival time ≤6 months；
• • Those who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders；
• • Have a history of immunodeficiency or other acquired or congenital immunodeficiency diseases; Or have an autoimmune disease；
• • According to the study, there are serious concomitant diseases that endanger the patient's safety or interfere with the patient's completion of the study；
• • Patients or family members could not understand the conditions and goals of the study；