Which guideline defines the lesion‑size criteria (up to three lesions ≤5 cm or a single lesion ≤8 cm) for trans‑arterial radio‑embolization in unresectable, transplant‑ineligible hepatocellular carcinoma with preserved Child‑Pugh A/early B liver function and no main portal‑vein thrombosis?

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Guideline Defining Lesion-Size Criteria for Trans-Arterial Radio-Embolization

The specific lesion-size criteria of "up to three lesions ≤5 cm or a single lesion ≤8 cm" for trans-arterial radio-embolization (TARE) in unresectable, transplant-ineligible hepatocellular carcinoma does not appear to be explicitly defined in any of the major international guidelines reviewed.

What the Guidelines Actually State About Lesion Size

Transplantation Criteria (Not TARE-Specific)

The guidelines extensively discuss lesion-size criteria for liver transplantation, not specifically for TARE:

  • Milan Criteria: Single tumors ≤5 cm in diameter or no more than 3 nodules ≤3 cm in diameter with no macrovascular invasion 1

  • UCSF Expanded Criteria: Single lesion ≤6.5 cm, or 2-3 lesions each ≤4.5 cm with total tumor diameter ≤8 cm 1, 2

  • UNOS Criteria: Single lesion 2-5 cm in diameter, or 2-3 lesions 1-3 cm in diameter 1

Ablation Criteria (Not TARE-Specific)

For radiofrequency ablation, the NCCN guidelines specify:

  • Single tumor ≤5 cm or multiple tumors (up to 3 tumors) each ≤3 cm in Child-Pugh class A patients 1

Trans-Arterial Therapies General Guidance

The NCCN guidelines state that "all tumors irrespective of location may be amenable to transarterial therapies provided that the arterial blood supply to the tumor may be isolated without excessive non-target treatment" 1, but no specific size criteria are provided for TARE.

Important Caveats

The criteria you describe (up to three lesions ≤5 cm or a single lesion ≤8 cm) appears to be a hybrid that does not match any standard guideline recommendation. This may represent:

  • Institution-specific protocols not captured in major society guidelines
  • Clinical trial eligibility criteria rather than guideline recommendations
  • A misinterpretation or conflation of different criteria sets

The KLCSG-NCC guideline recommends TACE for patients with good performance status without macrovascular invasion or extrahepatic spread who are ineligible for resection 1, but again provides no specific size cutoffs for TARE versus TACE.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Expanded criteria for liver transplantation in patients with hepatocellular carcinoma.

Hepatology research : the official journal of the Japan Society of Hepatology, 2007

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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