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The Results of neo-adjuvant intra-arterial [ 131 I]lipiodol in liver resection and transplantation for HCC  B. Launois, J....
Surgery for HCC <ul><li>Recurrences </li></ul><ul><ul><li>After resection 80-100% at 5 years </li></ul></ul><ul><ul><li>Af...
Injection of [ 131 I]Lipiodol <ul><li>131 I Lipiodol concentrates in the tumour </li></ul><ul><ul><li>Injection of 60 mCu ...
IA injection of [ 131 I] lipiodol <ul><li>Phase III: HCC with portal vein thrombosis </li></ul><ul><ul><li>[ 131 I] lipiod...
Pre-operative [ 131 I] lipiodol <ul><li>Well tolerated </li></ul><ul><li>Preserve liver vasculature </li></ul><ul><li>Aim:...
<ul><li>I – Liver resection versus transplantation with [ 131 I] lipiodol </li></ul><ul><li>II – Liver transplantation wit...
<ul><li>I – Liver resection versus Liver transplantation with [ 131 I] lipiodol </li></ul>
Study design <ul><li>Open study </li></ul><ul><li>Inclusion criteria </li></ul><ul><ul><li>HCC: proven/highly suspected </...
Patients <ul><li>26 male: 2 female </li></ul><ul><li>Age 57.6 +/-9.4 years </li></ul><ul><li>Cirrhosis: 24/28 </li></ul><u...
Tumours <ul><li>Number </li></ul><ul><ul><li>One (18) </li></ul></ul><ul><ul><li>Two (6) </li></ul></ul><ul><ul><li>Three ...
Surgery <ul><li>Resections  16 </li></ul><ul><ul><li>Tumour resection  11 </li></ul></ul><ul><ul><li>Hepatectomy 5 </li></...
Results: efficacy <ul><li>Tumour response: pathology size/CT size </li></ul><ul><ul><li>Progression >25%  (2) </li></ul></...
Tolerance <ul><li>IA injection of [ 131 I] lipiodol  </li></ul><ul><ul><li>Acute mesenteric infarction – 1 case </li></ul>...
 
 
 
 
 
 
<ul><li>II - Liver transplantation with and without [ 131 I] lipiodol </li></ul>
Patients 1 January 1987- 1 August 1999 <ul><li>52 patients (17.3%) </li></ul><ul><ul><li>HCC in cirrhotic liver (49) </li>...
Etiology of Cirrhosis <ul><li>Alcoholic  31 (60%) </li></ul><ul><li>Haemochromatosis  10 (19%) </li></ul><ul><li>Post-hepa...
Three groups <ul><li>A  One or 2 injections of [ 131 I] lipiodol 22 cases </li></ul><ul><li>B No injection of [ 131 I] lip...
Group Characteristics <ul><li>HCC+ [ 131 I]L: HCC, no [ 131 I]:Incidental P </li></ul><ul><li>No. 20 19 13 NS </li></ul><u...
Characteristics of 38 liver transplants <ul><li>  [ 131 I] lipiodol No [ 131 I] lipiodol P </li></ul><ul><li>No. 19 19 </l...
Protocol of IA injection of [ 131 I] lipiodol <ul><li>No previous neo-adjuvant treatment </li></ul><ul><li>IA injection un...
Morbidity post- [ 131 I] lipiodol injection in 20 patients <ul><li>Complication No. % </li></ul><ul><li>Decompensation 2 6...
Evaluation of response to [ 131 I] lipiodol <ul><li>Tumour size </li></ul><ul><li>Alpha fetoprotein </li></ul><ul><li>Tumo...
Efficacy of [ 131 I] lipiodol <ul><li>CT before (14) CT after (14) P </li></ul><ul><li>Σ diameter (mm) </li></ul><ul><li>M...
Efficacy by alpha-fetoprotein <ul><li>before [ 131 I] lipiodol after [ 131 I] lipiodol </li></ul><ul><li>No. 19 19 </li></...
Pathology of 51 liver transplants for HCC <ul><li>lipiodol No lipiodol Incidental P </li></ul><ul><li>No. patients 19 19 1...
Pathology of 51 LT for HCC <ul><li>Lipiodol No lipiodol Incidental </li></ul><ul><li>Tumoural necrosis </li></ul><ul><li>T...
Delay of Treatment <ul><li>Lipoidol no lipoidol P </li></ul><ul><li>No. patients 20 19 </li></ul><ul><li>Delay (days) </li...
Post-operative course <ul><li>lipiodol no lipiodol incidental P </li></ul><ul><li>No. 20 19 13 </li></ul><ul><li>Op. morta...
Months Overall survival of 52 liver transplant patients
months Liver transplant survival by tumour diameter <30mm 30-50mm >50mm
Survival of liver transplants with and without vascular invasion months No vascular invasion Vascular invasion
months Survival of liver transplants by experimental groups No   lipiodol incidental lipiodol
Cumulative survival of 52 patients <ul><li>lipiodol no lipiodol incidental overall </li></ul><ul><li>No.  20 19 13 52 </li...
Characteristics of recurrences <ul><li>4 recurrences (8%) </li></ul><ul><ul><li>Mean time after LT: 16 months (7-38) </li>...
Conclusions <ul><li>[ 131 I] lipiodol permits resection of HCC>3cm, 3yr survival is 42% </li></ul><ul><li>Pre-operative [ ...
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The results of neo-adjuvant intra-arterial lipiodol in liver resection and transplantation for HCC

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    1. 1. The Results of neo-adjuvant intra-arterial [ 131 I]lipiodol in liver resection and transplantation for HCC B. Launois, J.L. Raoul, L.A. Veilhan, B. Meunier, K. Boudjema, M. S. Metcalfe, G.J. Maddern Departments of Surgery University of Rennes (France) University of Adelaide (Australia) Bucharest (Romania) 9-11 April, 2003
    2. 2. Surgery for HCC <ul><li>Recurrences </li></ul><ul><ul><li>After resection 80-100% at 5 years </li></ul></ul><ul><ul><li>After OLT 40-50% if >5cm, 10% if <3cm </li></ul></ul><ul><li>Adjuvant treatments </li></ul><ul><ul><li>To improve results, decreasing recurrence rate </li></ul></ul><ul><ul><li>Chemoembolisation, chemotherapy </li></ul></ul><ul><ul><li>Retinoids </li></ul></ul><ul><ul><li>[ 131 I] lipiodol </li></ul></ul>
    3. 3. Injection of [ 131 I]Lipiodol <ul><li>131 I Lipiodol concentrates in the tumour </li></ul><ul><ul><li>Injection of 60 mCu [ 131 I] lipiodol </li></ul></ul><ul><ul><li>Without embolisation </li></ul></ul><ul><li>Biodistribution </li></ul><ul><ul><li>Phase I: well tolerated </li></ul></ul><ul><ul><ul><li>Radiology 1988 168: 541-5 </li></ul></ul></ul><ul><ul><li>Phase II: well tolerated with objective tumour response </li></ul></ul><ul><ul><ul><li>Cancer 1992 69: 346-52 </li></ul></ul></ul>
    4. 4. IA injection of [ 131 I] lipiodol <ul><li>Phase III: HCC with portal vein thrombosis </li></ul><ul><ul><li>[ 131 I] lipiodol vs medical support </li></ul></ul><ul><ul><li>Higher survival in treatment group </li></ul></ul><ul><ul><ul><li>J Nucl Med 1994; 35: 1782-7 </li></ul></ul></ul><ul><li>Phase III: unresectable HCC </li></ul><ul><ul><li>[ 131 I] lipiodol vs chemoembolisation </li></ul></ul><ul><ul><li>Equal efficacy, but [ 131 I] lipiodol better tolerated </li></ul></ul><ul><ul><ul><li>Hepatology 1997; 26: 1156-61 </li></ul></ul></ul>
    5. 5. Pre-operative [ 131 I] lipiodol <ul><li>Well tolerated </li></ul><ul><li>Preserve liver vasculature </li></ul><ul><li>Aim: </li></ul><ul><ul><li>To decrease recurrence rate </li></ul></ul><ul><ul><ul><li>Induce tumour necrosis </li></ul></ul></ul><ul><ul><ul><li>Treatment during the waiting period </li></ul></ul></ul><ul><ul><ul><li>Reduce micrometastases related to manipulation </li></ul></ul></ul>
    6. 6. <ul><li>I – Liver resection versus transplantation with [ 131 I] lipiodol </li></ul><ul><li>II – Liver transplantation with and without [ 131 I] lipiodol </li></ul>
    7. 7. <ul><li>I – Liver resection versus Liver transplantation with [ 131 I] lipiodol </li></ul>
    8. 8. Study design <ul><li>Open study </li></ul><ul><li>Inclusion criteria </li></ul><ul><ul><li>HCC: proven/highly suspected </li></ul></ul><ul><ul><li>Resection or transplantation candidate </li></ul></ul><ul><ul><li>Informed consent </li></ul></ul><ul><li>Treatment </li></ul><ul><ul><li>IA injection of [ 131 I] lipiodol at M 0 and M 2 </li></ul></ul><ul><ul><li>Isolation room 6 days </li></ul></ul><ul><ul><li>Surgery M 3 </li></ul></ul>
    9. 9. Patients <ul><li>26 male: 2 female </li></ul><ul><li>Age 57.6 +/-9.4 years </li></ul><ul><li>Cirrhosis: 24/28 </li></ul><ul><li>Child A (21), B (5), C (2) </li></ul><ul><li>Etiology: </li></ul><ul><ul><li>Alcohol (15) </li></ul></ul><ul><ul><li>Post-hepatitis (4) </li></ul></ul><ul><ul><li>Haemochromatosis (6) </li></ul></ul><ul><ul><li>Multiple (2) </li></ul></ul><ul><ul><li>Normal liver (1) </li></ul></ul>
    10. 10. Tumours <ul><li>Number </li></ul><ul><ul><li>One (18) </li></ul></ul><ul><ul><li>Two (6) </li></ul></ul><ul><ul><li>Three (1) </li></ul></ul><ul><ul><li>Four (3) </li></ul></ul><ul><li>Tumour size 5.7+/-4.2cm </li></ul><ul><ul><li><3cm (10) </li></ul></ul><ul><ul><li>3-5cm (8) </li></ul></ul><ul><ul><li>5-10cm (5) </li></ul></ul><ul><ul><li>>10cm (5) </li></ul></ul><ul><li>Tumour to liver volume ratio: </li></ul><ul><ul><li><25% (23) </li></ul></ul><ul><ul><li>25-50% (3) </li></ul></ul><ul><ul><li>>50% (2) </li></ul></ul>
    11. 11. Surgery <ul><li>Resections 16 </li></ul><ul><ul><li>Tumour resection 11 </li></ul></ul><ul><ul><li>Hepatectomy 5 </li></ul></ul><ul><li>Liver transplants 11 </li></ul><ul><li>Laparotomy 1 </li></ul>
    12. 12. Results: efficacy <ul><li>Tumour response: pathology size/CT size </li></ul><ul><ul><li>Progression >25% (2) </li></ul></ul><ul><ul><li>Stabilisation +/-25% (6) </li></ul></ul><ul><ul><li>Minor response 25-50% (12) </li></ul></ul><ul><ul><li>Objective response >50% (4) </li></ul></ul><ul><li>Pathological examination: % necrosis </li></ul><ul><ul><li>100% (5) </li></ul></ul><ul><ul><li>>90% (4) </li></ul></ul><ul><ul><li>50-90% (4) </li></ul></ul><ul><ul><li><50% (12) </li></ul></ul>
    13. 13. Tolerance <ul><li>IA injection of [ 131 I] lipiodol </li></ul><ul><ul><li>Acute mesenteric infarction – 1 case </li></ul></ul><ul><li>Surgery </li></ul><ul><ul><li>Post-operative deaths (<4 weeks): 2/28 (7%), </li></ul></ul><ul><ul><ul><li>Resection 1/16, transplantation 1/11 </li></ul></ul></ul><ul><ul><li>Severe side effects </li></ul></ul><ul><ul><ul><li>Liver failure – 1 death (4 months) </li></ul></ul></ul><ul><ul><ul><li>Septic complications – 1 death (2 months) </li></ul></ul></ul>
    14. 20. <ul><li>II - Liver transplantation with and without [ 131 I] lipiodol </li></ul>
    15. 21. Patients 1 January 1987- 1 August 1999 <ul><li>52 patients (17.3%) </li></ul><ul><ul><li>HCC in cirrhotic liver (49) </li></ul></ul><ul><ul><li>HCC in diseased liver (3) </li></ul></ul><ul><li>Mean age: 52 years (27-66) </li></ul><ul><ul><li>51 males, 1 female </li></ul></ul><ul><ul><li>Indication: HCC 39 cases (75%), incidental in 13 cirrhosis cases (25%) </li></ul></ul>
    16. 22. Etiology of Cirrhosis <ul><li>Alcoholic 31 (60%) </li></ul><ul><li>Haemochromatosis 10 (19%) </li></ul><ul><li>Post-hepatitis C 16 (31%) </li></ul><ul><li>Post-hepatitis B 4 (8%) </li></ul><ul><li>Multiple 8 (17%) </li></ul><ul><li>SEVERITY: </li></ul><ul><ul><li>Child A (23) B (15) C (14) </li></ul></ul><ul><ul><li>Mean Child Pugh Score: 7 (+/-2) </li></ul></ul>
    17. 23. Three groups <ul><li>A One or 2 injections of [ 131 I] lipiodol 22 cases </li></ul><ul><li>B No injection of [ 131 I] lipiodol 19 cases </li></ul><ul><li>C Incidental HCC 13 cases </li></ul>
    18. 24. Group Characteristics <ul><li>HCC+ [ 131 I]L: HCC, no [ 131 I]:Incidental P </li></ul><ul><li>No. 20 19 13 NS </li></ul><ul><li>Age (yrs) mean(sd) 51(5) 51.1(8.5) 54.9(5.3) NS </li></ul><ul><li>Etiology: </li></ul><ul><li>Alcoholic 11 (55%) 6 (32%) 6(46%) NS </li></ul><ul><li>+Haemochromatosis 2 (20%) 1 (5%) </li></ul><ul><li>Haemochromatosis 1 (5%) 4 (21%) </li></ul><ul><li>Alcohol+VHC 1 (5%) 1 (5%) 1 (8%) NS </li></ul><ul><li>VHC 3 (15%) 3 (16%) 6 (46%) NS </li></ul><ul><li>VHB+C 1 (5%) </li></ul><ul><li>VHB 3 (16%) </li></ul><ul><li>Child Pugh mean(sd) 7(2) 6(2) 10(2) </li></ul>
    19. 25. Characteristics of 38 liver transplants <ul><li> [ 131 I] lipiodol No [ 131 I] lipiodol P </li></ul><ul><li>No. 19 19 </li></ul><ul><li>Diameter(mm) </li></ul><ul><li>Mean(sd) 36 (15) 61 (45) 0.036 </li></ul><ul><li>Median 33 40 </li></ul><ul><li>Diameter 2 (mm 2 ) </li></ul><ul><li>Mean(sd) 1027(43) 4293(5820) 0.027 </li></ul><ul><li>Median 729 1225 </li></ul>
    20. 26. Protocol of IA injection of [ 131 I] lipiodol <ul><li>No previous neo-adjuvant treatment </li></ul><ul><li>IA injection under general anaesthesia in radiology department through catheter (Seldinger technique) </li></ul><ul><li>4 ml of lipiodol: mean activity 60millicuries (range 56-66) </li></ul><ul><li>Safety measures </li></ul><ul><ul><li>Containers </li></ul></ul><ul><ul><li>Lead-shielded Syringe </li></ul></ul><ul><ul><li>6 days patient isolation </li></ul></ul>
    21. 27. Morbidity post- [ 131 I] lipiodol injection in 20 patients <ul><li>Complication No. % </li></ul><ul><li>Decompensation 2 6 </li></ul><ul><li>Fever 3 8 </li></ul><ul><li>Abdominal pain 3 8 </li></ul><ul><li>Temporary encephalopathy 2 6 </li></ul><ul><li>Cough and dyspnoea 2 6 </li></ul><ul><li>Arthralgia 2 6 </li></ul>
    22. 28. Evaluation of response to [ 131 I] lipiodol <ul><li>Tumour size </li></ul><ul><li>Alpha fetoprotein </li></ul><ul><li>Tumour necrosis </li></ul><ul><li>Tolerance </li></ul><ul><li>Recurrence </li></ul><ul><li>Survival </li></ul>
    23. 29. Efficacy of [ 131 I] lipiodol <ul><li>CT before (14) CT after (14) P </li></ul><ul><li>Σ diameter (mm) </li></ul><ul><li>Mean (sd) 49(28) 32(22) 0.004 </li></ul><ul><li>Median (range) 39(20-110) 26(0-89) </li></ul><ul><li>Σ diameter 2 (mm 2 ) </li></ul><ul><li>mean (sd) 1307(896) 699(582) 0.003 </li></ul><ul><li>median (range) 968(320-3000) 462(0-1917) </li></ul>
    24. 30. Efficacy by alpha-fetoprotein <ul><li>before [ 131 I] lipiodol after [ 131 I] lipiodol </li></ul><ul><li>No. 19 19 </li></ul><ul><li>AFP </li></ul><ul><li>Mean(SD) 4798(16193) 2085(+/-8352) NS </li></ul><ul><li>Median (range) 30(1.4-70000) 8(1-36500) </li></ul>
    25. 31. Pathology of 51 liver transplants for HCC <ul><li>lipiodol No lipiodol Incidental P </li></ul><ul><li>No. patients 19 19 13 </li></ul><ul><li>No. tumours: </li></ul><ul><li>Median(range) 1(1-5) 1(1-5) 1(1-5) NS </li></ul><ul><li>Size of tumours: </li></ul><ul><li>Σ diameter (mm) </li></ul><ul><li>Mean (sd) 35(19) 53(37) 13(7) </li></ul><ul><li>Median (range) 34(0-70) 40(8-125) 11(5-30) 0.046 </li></ul>
    26. 32. Pathology of 51 LT for HCC <ul><li>Lipiodol No lipiodol Incidental </li></ul><ul><li>Tumoural necrosis </li></ul><ul><li>Total or >90% 4 (21%) 3 (16%) </li></ul><ul><li>Partial 11 (58%) 7 (37%) </li></ul><ul><li>Absent 2 (11%) 8 (42%) 13(100%) </li></ul><ul><li>Vascular involvement </li></ul><ul><li>Present 7 (37%) 2 (11%) 2 (15%) </li></ul><ul><li>Absent 11 (58%) 11 (58%) 11 (85%) </li></ul><ul><li>Unknown 1 (5%) 6 (32%) </li></ul>
    27. 33. Delay of Treatment <ul><li>Lipoidol no lipoidol P </li></ul><ul><li>No. patients 20 19 </li></ul><ul><li>Delay (days) </li></ul><ul><li>Mean (sd) 200(93) 140(133) NS </li></ul><ul><li>Median (range) 179(56-486) 106(11-500) </li></ul>
    28. 34. Post-operative course <ul><li>lipiodol no lipiodol incidental P </li></ul><ul><li>No. 20 19 13 </li></ul><ul><li>Op. mortality 4(20%) 6(32%) 1(8%) </li></ul><ul><li>Haemodynamic shock 1 1 1 </li></ul><ul><li>Septic shock 1 2 </li></ul><ul><li>Anaphylactic shock 1 </li></ul><ul><li>Acute rejection 2 </li></ul><ul><li>Acute respiratory fail. 2 </li></ul><ul><li>RC Packs 12(8) 15(10) 11(3) NS </li></ul><ul><li>Re-Tx 2(10%) 4(21%) 2(15%) NS </li></ul>
    29. 35. Months Overall survival of 52 liver transplant patients
    30. 36. months Liver transplant survival by tumour diameter <30mm 30-50mm >50mm
    31. 37. Survival of liver transplants with and without vascular invasion months No vascular invasion Vascular invasion
    32. 38. months Survival of liver transplants by experimental groups No lipiodol incidental lipiodol
    33. 39. Cumulative survival of 52 patients <ul><li>lipiodol no lipiodol incidental overall </li></ul><ul><li>No. 20 19 13 52 </li></ul><ul><li>1 year surv 77% 37% 92% 64% </li></ul><ul><li>3 year surv 77% 25% 92% 57% </li></ul><ul><li>5 year surv 77% 18% 48% </li></ul>
    34. 40. Characteristics of recurrences <ul><li>4 recurrences (8%) </li></ul><ul><ul><li>Mean time after LT: 16 months (7-38) </li></ul></ul><ul><ul><li>Location: Liver 3, Bone 1 </li></ul></ul><ul><li>According to pre-operative treatment </li></ul><ul><ul><li>[ 131 I] lipiodol: 0/19 patients </li></ul></ul><ul><ul><li>No [ 131 I] lipiodol: 3/19 patients (16%) </li></ul></ul><ul><ul><li>Incidental HCC: 1/13 patients (8%) </li></ul></ul>
    35. 41. Conclusions <ul><li>[ 131 I] lipiodol permits resection of HCC>3cm, 3yr survival is 42% </li></ul><ul><li>Pre-operative [ 131 I] lipiodol in liver transplantation for HCC of all sizes gives 5 year survival of 77%, compared to 18% without </li></ul><ul><li>There has been no recurrence in the [ 131 I] lipiodol group </li></ul>
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