Level of evidence | Strength of recommendation | |
Assessment of candidates with HCC for liver transplantation | ||
1. When considering treatment options for patients with HCC, the BCLC staging system is the preferred staging system to assess the prognosis of patients with HCC. | 2b (P) | Strong |
2. The TNM system (7th edition), including pathological examination of the explanted liver, should be used for determining prognosis after transplantation with the addition of assessment of microvascular invasion. | 2b (P) | Strong |
3. Either dynamic CT or dynamic MRI with the presence of arterial enhancement followed by washout on portal venous or delayed imaging is the best non-invasive test to make a diagnosis in cirrhotic patients suspected of having HCC and for preoperative staging. | 1b (D) | Strong |
4. Extrahepatic staging should include CT of the chest and CT or MRI of the abdomen and pelvis. | 3b (D) | Strong |
5. Tumor biopsy is not required in cirrhotic patients considered for liver transplantation who have high-quality dynamic CT or MRI findings typical for HCC and a lesion larger than 1 cm according to current AASLD guidelines. | 1b (D) | Weak |
6. For patients with lesions smaller or equal to 10 mm, non-invasive imaging does not allow an accurate diagnosis and should not be used to make a decision for or against transplantation. | 1b (D) | Strong |
Criteria for listing candidates with HCC in cirrhotic livers for DDLT | ||
7. Liver transplantation should be reserved for HCC patients who have a predicted five-year survival comparable to non-HCC patients. | NA | Weak |
8. Preoperative assessment of the size of the largest tumor or total diameter of tumors should be the main consideration in selecting patients with HCC for liver transplantation. | 2a (P) | Strong |
9. The Milan criteria are currently the benchmark for the selection of HCC patients for liver transplantation and the basis for comparison with other suggested criteria. | 2a (P) | Strong |
10. A modest expansion of the number of potential candidates may be considered on the basis of several studies showing comparable survival for patients outside the Milan criteria. | 3b (P) | Weak |
11. Patients with worse prognosis may be considered for liver transplantation outside the Milan criteria if the dynamics of the waiting list allow it without undue prejudice to other recipients with a better prognosis. | NA | Weak |
12. α-fetoprotein concentrations add prognostic information in HCC patients and may be used for making decisions regarding transplantation in combination with imaging criteria. | 2b (P) | Weak |
13. Biomarkers other than α-fetoprotein cannot yet be used for clinical decision making regarding liver transplantation for HCC. | 2b (P) | Strong |
14. Indication for liver transplantation in HCC should not rely on microvascular invasion because it cannot be reliably detected prior to transplantation. | 2b (P) | Strong |
Criteria for HCC candidates with non-cirrhotic livers | ||
15. The Milan criteria and its modifications are not applicable to patients with HCC developing in a non-cirrhotic liver. Such patients with non-resectable HCC and absence of macrovascular invasion and extrahepatic spread may be considered as appropriate candidates for liver transplantation. | 4 (P) | Weak |
16. Patients with HCC in non-cirrhotic liver who were treated by resection, and have intrahepatic recurrence of HCC and no evidence of lymph node or macrovascular invasion, may be considered for salvage transplantation. | 4 (P) | Weak |
Role of downstaging | ||
17. Transplantation may be considered after successful downstaging. | 5 (P) | Weak |
18. Liver transplantation after successful downstaging should achieve a five-year survival comparable to that of HCC patients who meet the criteria for liver transplantation without requiring downstaging. | 5 (P) | Strong |
19. Criteria for successful downstaging should include tumor size and number of viable tumors. | 4 (P) | Strong |
20. α-fetoprotein concentrations before and after downstaging may add additional information. | 4 (P) | Weak |
21. Based on existing evidence, no recommendation can be made for preferring a specific locoregional therapy for downstaging over others. | NA | None |
Managing patients on the waiting list | ||
22. Periodic waiting-list monitoring should be performed by imaging (dynamic CT, dynamic MRI, or contrast-enhanced ultrasonography) and α-fetoprotein measurements. | 5 (P) | Strong |
23. Based on current absence of evidence, no recommendation can be made on bridging therapy in patients with UNOS T1 (≤2 cm) HCC. | NA | None |
24. In patients with UNOS T2 (one nodule 2 to 5 cm or three or more nodules each ≤3 cm) HCC (Milan criteria) and a likely waiting time longer than six months, locoregional therapy may be appropriate. | 4 (P) | Weak |
25. No recommendation can be made for preferring any type of locoregional therapy to others. | NA | None |
26. Patients found to have progressed beyond criteria acceptable for listing for liver transplantation should be placed on hold and considered for downstaging. | 5 (P) | Strong |
27. Patients with progressive disease in whom locoregional intervention is not considered appropriate, or is ineffective, should be removed from the waiting list. | 5 (P) | Strong |
Role of LDLT | ||
28. LDLT is acceptable for HCC patients who have an expected five-year survival similar to comparably staged patients receiving a deceased donor liver. In LDLT, careful attention should be given to psychosocial considerations regarding both donor and recipient. | NA | Weak |
29. LDLT must be restricted to centers of excellence in liver surgery and liver transplantation to minimize donor risk and maximize recipient outcome. | NA | Strong |
30. In patients following LDLT for HCC within the accepted regional criteria for DDLT, retransplantation for graft failure is justified. | 5 (P) | Weak |
31. In patients following LDLT for HCC outside the accepted regional criteria for DDLT, retransplantation for graft failure using a deceased donor organ is not recommended. | 5 (P) | Strong |
Posttransplant management | ||
32. Posttransplant monitoring may include 6 to 12 monthly contrast-enhanced CT or MRI imaging and α-fetoprotein measurements. | 5 (P) | Weak |
33. There is currently insufficient evidence from clinical trials to base a recommendation for choosing the type or dose of immunosuppression therapy to influence the incidence of HCC recurrence or its prognosis. | NA | None |
34. Based on current evidence, no recommendation can be made on the use of mTOR inhibitors solely to reduce the risk of HCC recurrence outside clinical trials. | NA | None |
35. The current evidence does not justify the routine use of adjuvant antitumor therapy after liver transplantation for HCC outside of a controlled clinical trial. | NA | Weak |
36. HCC recurrence after liver transplantation may be treated by surgery for resectable lesions or by locoregional therapy or systemic therapy (including sorafenib) for unresectable lesions. | 4 (p) | Weak |
37. Liver retransplantation is not appropriate treatment for recurrent HCC. | NA | Strong |
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