# Milan — Classic Milan criteria for liver-transplant selection in hepatocellular carcinoma

> Binary tumor-burden selection boundary: one HCC 5 cm or smaller, or two to three HCCs each 3 cm or smaller, with no macrovascular invasion and no extrahepatic spread. It is not identical to OPTN T2, not automatic transplant eligibility or MELD exception, and not a patient-specific survival estimate; current use must preserve pretreatment and residual viable burden, AFP, liver function, performance status, contraindications and jurisdictional transplant policy.

**Situação:** vigente · **Órgão:** Fígado · **Órgão emissor:** Milan group / AASLD / transplant programs · **Versão:** 1996 classic criteria; AASLD 2023 care context; OPTN HCC policy effective 2025 reviewed 2026 · **Ano:** 1996

## Procedência e vigência
- Família: algoritmo
- Tipo de lógica: flat
- Modalidade: CT, MRI, Clinical
- Fonte primária: Mazzaferro V, Regalia E, Doci R, et al.. Liver transplantation for the treatment of small hepatocellular carcinomas in patients with cirrhosis (Milan criteria) (1996) — https://pmc.ncbi.nlm.nih.gov/articles/PMC5218905/
- Última verificação: 2026-07-24
- Última checagem: 2026-08-12

## Lógica de decisão
Assign classic Milan from a transparent lesion ledger, then separately reason about diagnosis, treatment response, OPTN policy, transplant eligibility and prognosis. Never use the binary label as an autonomous transplant decision.

## Categorias

| Código | Rótulo | Critérios | Conduta | Risco | Localizador | Verificado |
| --- | --- | --- | --- | --- | --- | --- |
| within-milan | Within classic Milan criteria | Within classic Milan requires either one viable HCC measuring 5 cm or smaller, or two to three viable HCCs each measuring 3 cm or smaller, with no macrovascular invasion and no extrahepatic spread. Use a lesion-by-lesion ledger and inclusive boundaries; after locoregional therapy report both presenting burden and current residual viable burden. | Within Milan supports transplant consideration only in an otherwise transplant-eligible patient after multidisciplinary evaluation of liver function, portal hypertension, performance status, resection options, AFP, contraindications and allocation context. It does not itself place the patient on a waiting list, award MELD exception points or choose transplant over resection or ablation. Evaluate OPTN T2 separately when US policy applies. | Within Milan identifies a selected cohort with generally favorable transplant outcomes, not this patient's survival or recurrence probability. AFP and tumor biology, treatment response, wait time, occult microvascular invasion, liver function, donor factors and center practice remain important; do not reuse historical cohort percentages as individualized risk. | Mazzaferro et al. NEJM 1996, DOI 10.1056/NEJM199603143341104, selection criteria; Singal et al. AASLD 2023, DOI 10.1097/HEP.0000000000000466, liver-transplantation section and recommendations 33-36; OPTN Policy 9.5.I.i-ii for separate T2 and AFP gates. | ✓ |
| beyond-milan | Beyond classic Milan criteria | Beyond classic Milan means a solitary viable HCC larger than 5 cm, two or three viable HCCs with any lesion larger than 3 cm, four or more viable HCCs, macrovascular invasion, and/or extrahepatic spread. State the exact reason because size/number excess, vascular invasion and metastasis have different policy and care implications. | Beyond Milan is not one treatment order or permanent futility. Patients otherwise transplant eligible whose excess is tumor size or number, especially those within UNOS downstaging inclusion, may be considered after successful downstaging to within Milan and 3-6 months of observation. Disease outside standard downstaging, macrovascular invasion or extrahepatic spread requires explicit multidisciplinary staging and policy review; US cases outside automatic criteria may require NLRB consideration. | Beyond Milan is a heterogeneous selection state, not a calibrated prognosis. Outcome depends on how the boundary is exceeded, AFP and biology, response and durability after locoregional therapy, liver function, performance status and metastatic or vascular disease; the label alone cannot establish transplant exclusion, recurrence probability or survival. | Singal et al. AASLD 2023, DOI 10.1097/HEP.0000000000000466, downstaging discussion, Figure 12 and recommendation 36; OPTN Policy 9.5.I.iii-iv for initial downstaging geometry, viable T2 response, NLRB routing and AFP rules; classic boundary from Mazzaferro et al. 1996. | ✓ |

### Citações por categoria
- **within-milan**: Singal AG, Llovet JM, Yarchoan M, et al.. AASLD Practice Guidance on prevention, diagnosis, and treatment of hepatocellular carcinoma (2023) — https://pmc.ncbi.nlm.nih.gov/articles/PMC10663390/ · Mazzaferro et al. NEJM 1996, DOI 10.1056/NEJM199603143341104, selection criteria; Singal et al. AASLD 2023, DOI 10.1097/HEP.0000000000000466, liver-transplantation section and recommendations 33-36; OPTN Policy 9.5.I.i-ii for separate T2 and AFP gates.
- **beyond-milan**: Singal AG, Llovet JM, Yarchoan M, et al.. AASLD Practice Guidance on prevention, diagnosis, and treatment of hepatocellular carcinoma (2023) — https://pmc.ncbi.nlm.nih.gov/articles/PMC10663390/ · Singal et al. AASLD 2023, DOI 10.1097/HEP.0000000000000466, downstaging discussion, Figure 12 and recommendation 36; OPTN Policy 9.5.I.iii-iv for initial downstaging geometry, viable T2 response, NLRB routing and AFP rules; classic boundary from Mazzaferro et al. 1996.

## Referências cruzadas
- _caracteriza_ → [LI-RADS — Liver Imaging Reporting and Data System, CT/MRI v2018](https://radcommons.laudos.ai/systems/li-rads-ct-mri-2018.md) — LI-RADS establishes observation-level diagnostic and treatment-response categories in an eligible population. Milan then aggregates confirmed viable HCC number, size, macrovascular invasion and extrahepatic spread; indeterminate LR observations are not automatically counted as HCC.
- _fronteira compartilhada_ → [BCLC — Barcelona Clinic Liver Cancer staging](https://radcommons.laudos.ai/systems/bclc.md) — Classic Milan is a tumor-burden transplant-selection boundary. BCLC separately integrates tumor extent, liver function and performance status to guide treatment; within Milan does not automatically determine BCLC stage or transplant.

## Histórico de versões

| Data | Evento | Detalhe | Situação |
| --- | --- | --- | --- |
| 2025-07-01 | revised | Current OPTN HCC exception policy aligned terminology further with LI-RADS and retained policy-specific T2, downstaging, viable-lesion and AFP gates. These US allocation rules are related to but not synonymous with classic Milan. | confirmed |
| 2023-05-22 | revised | AASLD current HCC guidance retained Milan as the transplant-selection boundary, distinguished transplant eligibility from listing and allocation, and recommended consideration after successful downstaging with a 3-to-6-month observation period. This did not alter the classic number-and-size criteria. | confirmed |
| 1996-03-14 | published | Milan criteria published by Mazzaferro et al. in the New England Journal of Medicine. | confirmed |


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> Conteúdo de referência reescrito. Confira a publicação primária vigente. Não é dispositivo médico nem substitui o julgamento clínico. O radiologista responsável pelo laudo permanece o autor e o responsável.

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