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Stefan Breitenstein Department of Visceral and Transplantation Surgery University Hospital Zurich

KSSG, 30. August 2012. SASL Tag der Leber 2012. Lebertransplantation bei HCC. Stefan Breitenstein Department of Visceral and Transplantation Surgery University Hospital Zurich. Case 1. Male patient 24 y Family, 2 children Hep B Cirrhosis with HCC AFP 220 MELD 8 Listed for Liver TPL.

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Stefan Breitenstein Department of Visceral and Transplantation Surgery University Hospital Zurich

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  1. KSSG, 30. August 2012 SASL Tag der Leber 2012 Lebertransplantation beiHCC Stefan Breitenstein Department of Visceral and Transplantation Surgery University Hospital Zurich

  2. Case 1 Male patient 24 y Family, 2 children Hep B Cirrhosis with HCC AFP 220 MELD 8 Listed for Liver TPL Radiology, MRI:

  3. Case 1 Male patient 24 y Family, 2 children Hep B Cirrhosis with HCC AFP 220 MELD 8 Listed for Liver TPL Question: What to do? • Escape from the list, no transplantation • Transplantation • Bridging (TACE, RF,…) and Transplantation

  4. Case 2 Question: What to do? Male patient 59 y Family, 2 children Hep C Cirrhosis with HCC AFP 14 MELD 25 • No transplantation, ablative treatment (TACT, RF, …) • Transplantation • Bridging (TACE, RF, resection) and Transplantation • other Radiology, MRI

  5. Survival after Liver TPL in Europe Dutkowski, Clavien, Gastroenterology, 2010

  6. Survival after Liver TPL in Europe 5 yr survival: > 70% Dutkowski, Clavien, Gastroenterology, 2010

  7. HCC: Therapeutic Options Radioembolization Chemoembolization Radiofrequency / Microwave Ablation ? Transplantation Resection Chemo-, Immunotherapy Cryo-Surgery

  8. Recommendations for Liver Transplantation for HCC: an International Consensus Conference Report Zurich, Switzerland 2-4 December 2010

  9. Aim • To establish the State of the Art regarding indications for OLT in patients with HCC • To provide internationally accepted statements & guidelines

  10. Endorsing Societies International HepatoPancreatoBiliary Association International Liver Cancer Association American Association for the Study of Liver Disease European HepatoPancreatoBiliary Association American Society of Transplant Surgeons International Liver Transplantation Society European Association for the Study of the Liver The Transplantation Society EuropeanLiver and Intestine Transplant Association Liver and Gastrointestinal Disease Foundation

  11. Methods Danish Model Organizing Committee Finest availableknowledge WELL IN ADVANCE Working Groups of Experts Jury Preparatory Meetings Boston Oct 2009 Vienna Apr 2010 Boston Oct 2010 Recommendations

  12. Methods ESSENTIAL RULE The members of the Jury draw the recommendations NOT the experts

  13. Level of Evidence Oxford Centre for Evidence-based Medicine

  14. Strength of recommendations GRADE System Grading of RecommendationsAssessment, Development and Evaluation BMJ 2008; 337: 327-30

  15. Publication Lancet Oncol. 2012 Jan;13(1)

  16. Liver TPL for HCC: Rational • Multifocal diseases • Best oncologic resection • Treatment of cirrhosis • Restores normal hepatic function

  17. Liver TPL for HCC: History Indications in the 80s/ 90s • Easier • Assumption of cure • No other options

  18. Liver TPL for HCC: History Authors years Mortality 3yr Survival Ringe 1989 34% 20% Iwatsuki 1991 15% 52% O ’Grady 1988 31% 32% Bismuth 1993 5% 49%

  19. MILAN Criteria Liver TPL für HCC: • Single tumor < 5 cm • Two-three tumors < 3 cm • No vascular invasion Mazzaferro et al., N Engl J Med 1996

  20. MILAN Criteria Mazzaferro et al., N Engl J Med 1996

  21. MILAN Criteria: Outcome Authors years Mortality 3yr Survival Ringe 1989 34% 20% Iwatsuki 1991 15% 52% O ’Grady 1988 31% 32% Bismuth 1993 5% 49% Mazzaferro 1996 6% 83% Figueras 1997 - 75% Llovet 1998 13% 74% Bismuth 1999 3% 68% Herrero 2001 - 76% Hemming 2001 15% 63% Beaujon 2001 10% 73% Ravaioli 2004 - 82% Milan Criteria

  22. Extended Criteria: UCSF Validation of University of California, San Francisco (UCSF) criteria. Criteria: Solitary Tumor < 6.5 cm < 3 nodules with largest lesion < 4.5 cm n = 168 patients with liver transplantation 38 patients exceeding Milan but meeting UCSF criteria Yao et al, Am J Transplantation 2007.

  23. Extended Criteria: UCSF Validation of University of California, San Francisco (UCSF) criteria. Criteria: Solitary Tumor < 6.5 cm < 3 nodules with largest lesion < 4.5 cm 5-year recurrence-free probability UCSF 93% Milan 90% Yao et al, Am J Transplantation 2007.

  24. Challenge of Milan Criteria

  25. Challenge of Milan Criteria Yao F et al, Am J Transpl, 2008

  26. What are the criteria for OLT? • LT within the Milan criteria (1 tumor <5cm or 3 < 3cm) achieves similar results than LT for non HCC patients: >70% 5-yr survival • UCSF criteria (1 tumor ≤ 6.5cm, ≤ 3 with the largest ≤ 4.5 cm and total tumour Ø ≤ 8 cm) : same outcome in retrospective studies

  27. What are the criteria for OLT?

  28. Negative risk factors of survival for HCC • Multifocal tumor • Size of tumor • Poor differentiation • Lympho/ vascular invasion • AFP > 400 – 1000 ng/ml

  29. Allocation for Liver TPL Model for End-stage Liver Diseases: MELD Score 2002 «United Network for Organ Sharing» (UNOS): To grade patients on the waiting list according to the severity of liver disease • Serum Creatinine (mg/dl) • Bilirubin (mg/dl) • INR Score 6 - 40 10 x (0.957 (Serum Crea) + 0.378 (Bilirubin) + 1.12 (INR) + 0.643) Wiesner R et al., Gastroenterology, 2003 Kamath PS et al, Hepatology 2001

  30. Allocation for Liver TPL Model for End-stage Liver Diseases: MELD Score Highly predictive of the risk of dying from liver disease for patients on the waiting list Switzerland: Allocation according to MELD since 2007

  31. Swisstx Eurotx UNOS • MEDIAN of the MELD score of all liver-patients of the month before: 14 • 1pt in addition every month on the waiting list • Minimum 22 • Upgrade 10% MELD equivalent (3 months) • T1(< 2 cm) +0 pts • 33% OLT without HCC ! • T2 (2-5 cm) 22 pts • T3 – T4: +0 pts • negative prognostic Allocation: Problem HCC - MELD • Patients with HCC often have low MELD score • Long waiting time for Liver TPL Extra points

  32. Allocation: Problem HCC - MELD TPL Decision Transplantation Tumor growth Vascular invasion Risk of Drop-out (2-4% / mt) Loss of benefit of TPL • Tumor progression • CH: waiting time: 7 - 9 months for HCC patients

  33. Allocation: Problem HCC - MELD Consequences of long waiting time: 1. Monitoring Contrast imaging every 3 mt (MRI) 2. Bridging - Trans-Arterial-Chemoembolization (TACE) - Percutaneous treatment (RFA) - Resection

  34. Trans-Arterial-Chemoembolisation as Bridge

  35. Trans-Arterial-Chemoembolisation as Bridge Only retrospective studies! Kim et al., JACS, 2007

  36. Trans-Arterial-Chemoembolisation as Bridge • Improvement of long-term survival: unclear • No increase of post-operative complications • Insufficient evidence about TACE benefits • Impact of hyperselective TACE ? Lesurtel et al, Am. J. Transplant. 2006

  37. Radiofrequency Ablation as Bridge • No randomized studies • Controversial results • Morbidity 2,2%, mortality 0,3% • Good option for Child A-B patients with expected waiting time >6 months Kim et al, JACS, 2007 Lau et al, Ann Surg 2009

  38. Resection as Bridge Without recurrence With recurrence Salvage OLT

  39. Resection as Bridge (Within Milan) • Primary OLT Secondary OLT • after liver resection • n = 70 n = 18 36 (51%) 4 (6%) Morbidity Mortality 10 (56%) 1 (6%) Belghiti J et al., Ann Surg 2003; 238: 885-893

  40. Resection as Bridge 1.0 0.8 0.6 0.4 0.2 0 64% 58% Disease-freesurvival p=0.003 29% 29% Primary LT (n=195) LT after resection (n=17) 0 1 2 3 4 5 Years “OLT after liver resection is associated with an increased risk of recurrence and poorer outcome than primary OLT“ Adam R et al. Ann Surg,2003

  41. Resection as Bridge 61 Resection of HCC within the Milan criteria Mean follow-up 4.3 years Recurrence present 31 (51%) Salvage LT possible: 24 out of 31 (77%) 5-year survival: 85% Cherqui D et al., Ann Surg 2009

  42. Is treatment of HCC on the waiting list necessary?

  43. Does a patient qualify for OLT after downstaging?

  44. Contraindications for Liver TPL Cirrhosis, HCC: • Tumor specific factors • Age > 60 – 70 • Protal vein occlusion • Hypertension A. pulmonalis

  45. Liver TPL: Current problem Shortage of organs Extend donor criteria (marginal organs) Increase of donor rates Living Related Liver Transplantation Split Liver Transplantation

  46. Living Related Liver Transplantation

  47. Living Related Liver Transplantation Donor

  48. Living Related Liver Transplantation

  49. Living Related Liver Transplantation Recepient Donor

  50. Living Related Liver Transplantation Advantages • Shorten waiting time • < 2 - 4 weeks • High quality graft • > 95 % 1yr survival • Positive impact on pool of organs

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