What are the Milan Criteria?
The Milan Criteria are a set of guidelines used to select patients with
hepatocellular carcinoma (HCC) for liver transplantation. These criteria were first established in 1996 by Dr. Vincenzo Mazzaferro and colleagues in Milan, Italy. The goal of the criteria is to identify patients with HCC who are most likely to benefit from a liver transplant, thereby optimizing outcomes and improving survival rates.
A single HCC tumor ≤ 5 cm in diameter
Up to three HCC tumors, each ≤ 3 cm in diameter
No evidence of macrovascular invasion or extrahepatic spread
Patients who meet these criteria have been shown to have a post-transplant survival rate comparable to patients without HCC.
Why are the Milan Criteria Important?
The Milan Criteria have become the gold standard for selecting HCC patients for liver transplantation. The criteria help to ensure that liver transplants are allocated to patients who have the highest likelihood of benefiting from the procedure. This is particularly important given the limited availability of donor organs.
How do the Milan Criteria Compare to Other Selection Criteria?
Several other criteria have been proposed for selecting HCC patients for liver transplantation, including the
UCSF Criteria and the
Up-to-7 Criteria. While these alternative criteria are less stringent and allow for the inclusion of patients with slightly larger or more numerous tumors, they have not been universally adopted. The Milan Criteria remain the most widely used due to their simplicity and proven efficacy in predicting post-transplant outcomes.
Are There Any Limitations to the Milan Criteria?
While the Milan Criteria have been highly successful, they are not without limitations. One criticism is that they may exclude some patients who could benefit from a liver transplant. For example, patients with slightly larger tumors or more than three tumors may still have good outcomes but would be excluded under the Milan Criteria. Additionally, advances in imaging and
tumor biomarkers may allow for better prediction of outcomes, potentially necessitating updates to the criteria in the future.
Can Patients Outside the Milan Criteria Still Receive a Liver Transplant?
Yes, patients who do not meet the Milan Criteria may still be considered for liver transplantation on a case-by-case basis. These patients may be evaluated using expanded criteria or based on other factors such as response to
locoregional therapy. However, the decision to proceed with transplantation in these cases is typically made by a multidisciplinary team and may be subject to the availability of donor organs.
What is the Future of the Milan Criteria?
As our understanding of HCC continues to evolve, the Milan Criteria may be updated or supplemented with new selection guidelines. Advances in
genomic profiling and
immunotherapy are likely to play a role in refining patient selection for liver transplantation. Additionally, ongoing research into
predictive biomarkers and improved imaging techniques may provide better tools for assessing which patients are most likely to benefit from a transplant.
Conclusion
The Milan Criteria have been instrumental in improving outcomes for HCC patients undergoing liver transplantation. By providing a clear and evidence-based framework for patient selection, these criteria have helped to maximize the benefits of liver transplantation while ensuring the judicious use of donor organs. As medical science advances, it will be important to continue refining these criteria to reflect new knowledge and technologies, thereby further improving outcomes for patients with HCC.
