Milan Criteria for Liver Transplantation

Evaluates whether cirrhosis and hepatocellular carcinoma patients are viable liver transplantation (OLT) candidates.

Refer to the text below the calculator for more information about the criteria for orthotopic liver transplant (OLT).


Liver transplantation is an effective treatment for small, unresectable hepatocellular carcinomas in patients with cirrhosis. However, as with orthotopic liver transplantation is difficult to predict successful outcomes, the Milan criteria helps assess candidates’ suitability.


The Milan criteria is considered met by the following:

YES to:

  • A single HCC nodule with a maximum size of 5 cm;

OR

  • Up to 3 nodules with the largest not exceeding 3 cm;

NO to:

  • Extra-hepatic involvement;
  • Major vessel involvement.

1A single HCC nodule with a maximum size of 5 cm
2Up to 3 nodules with the largest not exceeding 3 cm
3Extra-hepatic involvement
4Major vessel involvement
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Milan Criteria for Hepatocellular Carcinoma Patients

Liver transplantation is an effective treatment for small, unresectable hepatocellular carcinomas in patients with cirrhosis.

However, as with orthotopic liver transplantation is difficult to predict successful outcomes, the Milan criteria helps assess candidates’ suitability.

The criteria was originally developed in 1996 by Mazzaferro et al. to identify patients with cirrhosis and early stage hepatocellular carcinoma, that were likely to benefit from liver transplantation and were more likely to sustain successful outcomes. It is now recommended by the guidelines from the American Association for the Study of Liver Disease (AASLD).

The Milan criteria is considered met by the following:

YES to:

  • A single HCC nodule with a maximum size of 5 cm

OR

  • Up to 3 nodules with the largest not exceeding 3 cm

NO to:

  • Extra-hepatic involvement
  • Major vessel involvement

Patients who fulfil the criteria may undergo full evaluation for OLT. This may include hepatology consultations, laboratory studies, determination of MELD score, assessment of other comorbidities and surgical evaluation.

Patients who do not meet the criteria may undergo locoregional therapy (e.g. transarterial chemoembolization or radioembolization with Yttrium-90) before a further re-assessment.

The original study analysed a cohort of 48 patients with cirrhosis (in 94% of causes cirrhosis was caused by infection with hepatitis B or C virus or both) who had small, unresectable hepatocellular carcinomas and who underwent liver transplantation.

The presence of tumor was confirmed by biopsy or serum alpha-fetoprotein assay. 33 patients had undergone chemoembolization before OLT. After liver transplantation, the patients were followed prospectively for a median of 26 months (shortest 9 months, longest 54 months).

The overall mortality was 17% (median follow-up 26 months, range 9-54 months), and actuarial survival at 4 years was 75% and the rate of recurrence-free survival was 83%.

In 2011, a systematic review analysed data from 25 studies concerning patients undergoing OLT and showed that patients who also met the Milan criteria had a better prognosis than those who didn’t and that their survival rates were similar to patients undergoing liver transplantation for non-malignant indications.

 

References

Original references

Mazzaferro V, et al. Milan criteria in liver transplantation for hepatocellular carcinoma: An evidence-based analysis of 15 years of experience. Liver Transpl. 2011; 17 Suppl 2:S44-57.

Mazzaferro V, Regalia E, Doci R, et al. Liver transplantation for the treatment of small hepatocellular carcinomas in patients with cirrhosis. N Engl J Med. 1996; 334(11):693-9.

Other references

Heimbach JK, Kulik LM, Finn RS, et al. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018; 67(1):358-380.

Martin P, DiMartini A, Feng S, Brown R Jr, Fallon M. Evaluation for liver transplantation in adults: 2013 practice guideline by the American Association for the Study of Liver Diseases and the American Society of Transplantation. Hepatology. 2014; 59(3):1144-65.


Specialty: Transplantation

Objective: Eligibility check

Year Of Study: 1996

Article By: Denise Nedea

Published On: July 6, 2020

Last Checked: July 6, 2020

Next Review: July 6, 2025