Impact of surgical margin width on recurrence and survival in liver cancer from colorectal metastasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates how the width of surgical margins affects the prognosis of patients with hepatic oligometastasis from colorectal cancer. It is a single-center, prospective, randomized controlled trial that aims to assess the 1-year intrahepatic recurrence-free survival rate, overall survival time, and relapse-free survival time. Additionally, the study will compare the safety of wide margin surgery versus narrow margin surgery during the perioperative period. Patients will undergo radical resection of liver metastases, with careful preoperative assessments to ensure optimal surgical outcomes.

Why it matters

Who can join: the full rules

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；

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Lu Wang, PhD
• Email: w.lr@hotmail.com
• Phone: +8613601678615

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.