1. Pathological diagnostic criteria: HCC is diagnosed by pathological histology and/or cytology of liver lesions or extrahepatic metastases through biopsy or surgical resection of tissue specimens. This is the gold standard. 2. Clinical diagnostic criteria: Among all solid tumors, only HCC can be diagnosed using clinical diagnostic criteria, which are recognized both domestically and internationally, are non-invasive, simple and convenient, and highly operational. It is generally believed that the criteria depend on three major factors, namely, chronic liver disease background, imaging examination results, and serum AFp levels. However, the academic community has different understandings and specific requirements, which often change, and there are errors in actual application. Therefore, based on my country's national conditions, previous domestic standards, and clinical practice, the expert group proposes that the clinical diagnosis of HCC can be established when two of the following conditions (1) + (2) a or three of (1) + (2) b + (3) are met at the same time: Li Jun, Department of Oncology, Mianyang Second People's Hospital (1) Patients with evidence of liver cirrhosis and HBV and/or HCV infection (HBV and/or HCV antigen positive); (2) Typical imaging features of HCC: Concurrent multi-slice CT scans and/or dynamic contrast-enhanced MRI examinations show rapid heterogeneous vascular enhancement (arterial hypervascularity) of the liver lesions in the arterial phase and rapid washout (venous or delayed phase washout). ① If the diameter of the liver mass is ≥2 cm, and one of the two imaging examinations, CT and MRI, shows that the liver mass has the above-mentioned characteristics of liver cancer, HCC can be diagnosed; ② If the diameter of the liver mass is 1-2 cm, both CT and MRI imaging examinations are required to show that the liver mass has the above-mentioned characteristics of liver cancer before HCC can be diagnosed in order to enhance the specificity of the diagnosis. (3) Serum AFp ≥ 400 μg/L for 1 month or ≥ 200 μg/L for 2 months, and other causes of AFp elevation can be excluded, including pregnancy, germline embryonic tumors, active liver disease, and secondary liver cancer. 3. Notes and instructions. (1) Many foreign guidelines (including AASLD, EASL and NCCN CpGs) emphasize the use of multi-row CT scans and/or dynamic contrast-enhanced MRI for liver masses, and these should be performed in experienced imaging centers. At the same time, it is believed that accurate imaging diagnosis of HCC requires four-phase scanning examinations: plain phase, arterial phase, venous phase and delayed phase. The lesion should be scanned with a thin 5 mm scan, and the importance of arterial phase enhancement in imaging examinations is highly valued. The characteristic of HCC is that the early arterial lesions can be significantly enhanced, with a higher density than normal liver tissue, and the venous enhancement disappears rapidly, with a lower density than the surrounding normal liver tissue. If the imaging features of the liver mass are atypical, or the imaging of the CT and MRI examinations are inconsistent, a liver puncture biopsy should be performed, but even a negative result cannot completely rule out the possibility of HCC, and follow-up observation is still required. (2) In recent years, clinical observations and research results at home and abroad have suggested that serum AFp can also be elevated in some patients with ICC and gastrointestinal cancer liver metastasis, and ICC is often accompanied by liver cirrhosis. Although the incidence of ICC is much lower than that of HCC, both are common in patients with liver cirrhosis. Therefore, liver space-occupying lesions with elevated AFp are not necessarily HCC and need to be carefully differentiated. In my country and most countries in the Asia-Pacific region, patients with significantly elevated AFp are mostly HCC, which still has differentiation value compared with ICC, so it is used as a diagnostic indicator for HCC. (3) For patients with serum AFp ≥ 400 μg/L and no liver mass found by ultrasound examination, pregnancy, embryonic tumors of the reproductive system, active liver disease, and gastrointestinal hepatic adenocarcinoma should be excluded; if these conditions can be excluded, multi-row CT and/or dynamic contrast-enhanced MRI scans must be performed in a timely manner. If typical HCC imaging features are present (rich blood vessels in the arterial phase and disappearance in the portal venous phase or delayed phase), HCC can be diagnosed. If the examination results or vascular images are not typical, other imaging modes should be used for contrast-enhanced examinations, or liver biopsy of the lesions should be performed. Simple arterial phase enhancement without venous phase disappearance is insufficient evidence for the diagnosis of HCC. If AFp is elevated but does not reach the diagnostic level, in addition to excluding the above-mentioned conditions that may cause AFp increase, the changes in AFp must be closely observed and tracked, and the interval between ultrasound examinations should be shortened to 1-2 months. Dynamic observation of CT and/or MRI should be performed when necessary. If liver cancer is highly suspected, further selective hepatic artery angiography (DSA) examination is recommended, and liver puncture biopsy can be performed as appropriate if necessary. (4) For patients with liver space-occupying lesions but no elevated serum AFp and no imaging features of liver cancer in imaging examinations, if the diameter is <1 cm, close observation is acceptable. If no vascular enhancement is observed in dynamic imaging of the liver space-occupying lesion, the possibility of malignancy is low. If the space-occupying lesion gradually increases or reaches a diameter ≥2 cm, further examinations such as ultrasound-guided liver puncture biopsy should be performed. Even if the liver biopsy result is negative, it should not be easily denied and follow-up should be performed; imaging follow-up should be performed every 6 months until the lesion disappears, increases in size, or presents diagnostic features of HCC; if the lesion increases in size but still shows no typical HCC changes, a repeated liver biopsy can be considered. (5) It should be pointed out that among HCC in my country, 5%-20% of patients do not have a background of liver cirrhosis, about 10% of patients have no evidence of HBV/HCV infection, and about 30% of patients have serum AFp < 200 μg/L. At the same time, most HCCs have hypervascular features on imaging, but a few do show hypovascular features. In addition, in Europe and the United States, there have been many reports that patients with non-alcoholic steatohepatitis (NASH) can develop liver cirrhosis and then develop HCC (NASH-related HCC), but there is still a lack of relevant data in my country. |
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