What are the Milan criteria (Milan Criteria) for liver transplantation?

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Last updated: February 10, 2025View editorial policy

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From the Guidelines

The Milan Criteria for liver transplantation are a set of guidelines that recommend liver transplantation for patients with hepatocellular carcinoma (HCC) who have a single tumor less than or equal to 5 cm in diameter or up to three nodules less than or equal to 3 cm in diameter, with no vascular invasion.

Key Points

  • The Milan Criteria are used to select patients with HCC for liver transplantation, with the goal of achieving a 5-year survival rate of 70% or higher after transplantation 1.
  • The criteria include:
    • A single tumor less than or equal to 5 cm in diameter
    • Up to three nodules less than or equal to 3 cm in diameter
    • No vascular invasion
  • Patients who meet the Milan Criteria have a significant survival advantage compared to those who do not meet the criteria, with a 5-year survival rate of 65-80% 1.
  • The Milan Criteria have been widely adopted and are considered the benchmark for selecting patients with HCC for liver transplantation 1.

Rationale

The Milan Criteria were established based on a landmark study published in 1996, which showed that patients with HCC who met these criteria had a significantly better survival rate after liver transplantation compared to those who did not meet the criteria 1.

Clinical Application

The Milan Criteria are used in clinical practice to select patients with HCC for liver transplantation, and to prioritize patients on the waiting list for transplantation 1.

Limitations

While the Milan Criteria are widely accepted, there is some debate about whether they should be expanded to include patients with more advanced disease, and whether other factors such as tumor biology and patient performance status should be taken into account when selecting patients for liver transplantation 1.

From the Research

Definition of Milan Criteria

The Milan criteria are a set of guidelines used to select patients with hepatocellular carcinoma (HCC) for liver transplantation [(2,3,4,5,6)].

Key Components of Milan Criteria

The key components of the Milan criteria include:

  • The patient must have a single tumor less than or equal to 5 cm in size, or
  • The patient must have no more than 3 tumors, each less than or equal to 3 cm in size [(2,3,4,5,6)].

Purpose of Milan Criteria

The purpose of the Milan criteria is to identify patients with HCC who are likely to have a good outcome after liver transplantation, with a low risk of tumor recurrence [(2,3,4,5,6)].

Limitations and Expansion of Milan Criteria

Some studies have suggested that the Milan criteria may be too restrictive, and that expansion of these criteria may be possible without compromising patient outcomes [(2,3,4,5)].

  • Proposed expanded criteria include the University of California, San Francisco (UCSF) criteria and the Hangzhou criteria [(2,6)].
  • These expanded criteria may allow more patients to be considered for liver transplantation, while still maintaining a good prognosis [(2,3,4,5)].

Factors Affecting Patient Outcomes

Factors that affect patient outcomes after liver transplantation for HCC include:

  • Tumor size and number
  • Presence of microvascular invasion
  • Alpha-fetoprotein (AFP) levels
  • Tumor burden [(2,3,4,5,6)].

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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