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    Patent Pending

    Milan Criteria for Liver Transplantation

    Assess suitability of patients for liver transplant with cirrhosis and hepatocellular carcinoma.
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    When to Use
    Pearls/Pitfalls
    Why Use
    • Patients with hepatocellular carcinoma (HCC) being considered for orthotopic liver transplant (OLT).
    • Originally developed by Mazzaferro and colleagues in Milan in 1996 to identify cirrhotic patients with early stage HCC likely to benefit from transplant.
    • Widely validated.
    • HCC as an indication for OLT was controversial before Milan Criteria were published; now it is an accepted indication and still used today in its original iteration.
    • Patients not meeting Milan Criteria at presentation can potentially be downstaged with locoregional therapy such as transarterial chemoembolization (TACE) or radioembolization with Yttrium-90 (Y90), though it is not known whether pre-transplant downstaging reduces post-transplant survival.
    • OLT cures HCC, but the procedure itself is extremely high risk.
    • The Milan Criteria identify patients most likely to benefit from transplantation.

    Result:

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    Next Steps
    Evidence
    Creator Insights

    Advice

    • In addition to standard workup for HCC, patients who fulfill the Milan Criteria should undergo full evaluation for OLT, including but not limited to assessment for comorbid conditions, appropriate laboratory studies, calculation of MELD, hepatology consultation, surgical evaluation, and referral to transplant center (Martin 2014).
    • Monitor for potentially treatable hepatic decompensation (ascites, encephalopathy, variceal bleeding).

    Formula

    • Single tumor with diameter ≤5 cm OR up to 3 tumors, each with diameter ≤3 cm, AND
    • No major vessel or extra-hepatic involvement.

    Evidence Appraisal

    • In 1996, Mazzaferro and colleagues in a prospective cohort study of 48 patients with cirrhosis and HCC in Milan, Italy, who then underwent OLT. 
    • The eligibility criteria for the study were what are today known as the Milan Criteria: a single tumor ≤5cm or ≤3 tumors, ≤3cm. 
    • Overall mortality was 17% (median followup 26 months, range 9-54 months), and actuarial survival at 4 years was 75%.
    • A systematic review published in 2011 conducted by the same group included a meta-analysis of 25 studies looking at patients undergoing OLT according to the Milan criteria and found that not only did these patients have a better prognosis than those not fulfilling the criteria, but also the survival was similar to patients undergoing OLT for non-malignant indications.
    • Review of final pathology also showed that the Milan Criteria identified a subset of patients with lower grade tumors.

    Literature

    Dr. Vincenzo Mazzaferro

    About the Creator

    Vincenzo Mazzaferro, MD, is a professor of medicine and director of the hepato-gastro-pancretic and liver transplant service at the Insituto Nazionale dei Tumori in Milan. He is one of the founders of the Cancer Insitute of Milan, which was responsible for the development of the Milan Criteria, which has been adopted as a transplant guideline in many countries. He is an avid researcher on transplantation, but also studies treatment of metastatic cancers to the liver and novel treatments of tumors.



    To view Dr. Vincenzo Mazzaferro's publications, visit PubMed