CHIRURGIA EPATOBILIARE IN WEEK SURGERY?

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1 U.O.C. di Chirurgia Epatobiliare e dei Trapianti Epatici Università degli Studi di Padova CHIRURGIA EPATOBILIARE IN WEEK SURGERY? Umberto Cillo, MD, PhD, FEBS cillo@unipd.it

2 Quali sono gli ingredienti necessari? Minimally Invasive Expertise Fast-Track (ERAS) Pre-operative Selection

5 Tanaka S et al, J Am Coll Surg 2017;225:249e 258

6 Tanaka S et al, J Am Coll Surg 2017;225:249e 258

7 Preoperative evaluation with the difficulty scoring system predicted the difficulty of the operation and the postoperative outcomes of LLR In the beginning of LLR training surgeons should start with low difficulty-level operations. Tanaka S et al, J Am Coll Surg 2017;225:249e 258

8 Not a good indication for A week Surgery Programme...not yet? Lee A et al. BMJ Open 2014;4:e005330

9 Padova Experience st August 2017

10 Padova Experience st August

11 Padova Experience st August Liver Ablation

12 Padova Experience st August Laparoscopic LA 1604 Percutaneous LA

13 Laparoscopic Approach The goal of a local ablative treatment is complete tumor destruction with minimal side effects Miniaturization of the access Advantages of laparoscopy: Direct visualization of the abdominal cavity Better tumor staging using IOUS Higher frequency More accurate and precise needle placement Opportunity to detect extrahepatic spread Therapeutic implications in preventing thermal injury Pneumoperitoneum: Decreases tissue perfusion Reduces convective heat sink phenomena larger ablation areas Less local treatment failures Eisele RM, World J Gastroenterol 2016 April 21; 22(15):

14 HCC: Criteria for Laparoscopic Approach Patients meeting at least one of the following criteria: Patients meeting at least one of the following criteria: 1. Patients with a single nodule or up to three nodules <3 cm not suitable for OLT 1. Patients not eligible for HR: Major HR in BCLC A2-A3-A4 patients Technical contraindications 2. Patients not suitable for percutaneous ablation: Critical location (proximity to GI tract or bladder or major hepatic vessels; superficial exophytic nodules) Tumor extension (size 3 cm or 3 nodules) Untreatable ascites Severe coagulopathy (PT<40% and/or PTLS <30.000) 1. Patients not eligible for HR: Severe PH Impaired liver function Coexistent comorbidities 2. Patients not suitable for percutaneous RFA because of: PLTS < and/or INR >1.20 Superficial lesions adjacent to abdominal viscera Deep-sited lesions with very difficult or impossible percutaneous approach (HCCs undetectable at US, or contiguous to primary biliary or portal tributaries); Short-term recurrence of HCC (<3 months) following PEI; RFA or TACE Exclusion criteria: Severe liver disease (CPT-C, MELD > 20) Large multinodular HCC (size > 7 cm, Number >5) Exclusion criteria: Complete portal thrombosis and/or Coexisting severe liver disease (CPT-C) Cillo U et al, PLoS one 2013, Vol 8, 2, e57249 Santambrogio R et al, Surg Endosc (2016) 30:

15 3 RCTs and 25 NRCTs were included 11,873 patients involved - 6,094 RFA - 5,779 HR The effectiveness of RFA is comparable to HR with fewer complications but higher recurrence especially for very early HCC patients Wang J et al, PLoS one 2014, 1, e84484

233 patients with liver malignancies treated by RFA From 2003 to 2011 75.5% HCC RFA approaches used: - Percutaneous: 58.4% - Laparoscopic: 9.4% - Open: 32.

16 233 patients with liver malignancies treated by RFA From 2003 to % HCC RFA approaches used: - Percutaneous: 58.4% - Laparoscopic: 9.4% - Open: 32.2% Median follow-up: 29 months Complete ablation: 83.7% (no differences) Intra-hepatic recurrence: 69.5% (no differences) Extra-hepatic recurrences: 22.3% (no differences) Surgical group: more wound and chest complications No difference was demonstrated between the percutaneous and surgical approach No statistical difference between the two approaches in terms of recurrence and survival in overall 1-, 3- and 5-year survival Wong J et al, HPB 2013, 15,

706 HCC Milan-IN patients 424 RFA 282 TACE Performance status: 0 516 patients 1 190 patients propensity-score matching 167matched pairs with PS 0 68 matched pairs with PS 1 RFA provided significantly

17 706 HCC Milan-IN patients 424 RFA 282 TACE Performance status: patients patients propensity-score matching 167matched pairs with PS 0 68 matched pairs with PS 1 RFA provided significantly better long-term survival than TACE in patients with a PS 0 (p<0.05) TACE was significantly associated with 1.784x increased risk of mortality (95 % CI ) RFA should be considered a priority treatment in inoperable HCC Milan-IN patients Performance status is a feasible surrogate marker to enhance treatment allocation Liu HP et al, Ann Surg Oncol 2014, 21:

18 LAPAROSCOPIC ABLATION OF HEPATOCELLULAR CARCINOMA IN CIRRHOTIC PATIENTS UNSUITABLE FOR LIVER RESECTION OR PERCUTANEOUS TREATMENT: A COHORT STUDY Prospective study (January 2004 December 2009) 169 laparoscopic ablation for HCC 72% Clinically relevant portal hypertension 50% Multinodular tumors or nodules > 25 mm 15% Incomplete LA at first imaging study Ablation techniques: 103/169 (61%): RFA 8/169 (5%): MWA 58/169 (34%): EIA 28% Incidence of early local recurrence 24% Distant recurrence during the study period BCLC (p =0,0822) BCLC A BCLC B Laparoscopic ablation is a safe and effective therapeutic option for selected HCC patients ineligible for liver resection and/or percutaneous ablation LT Need for RCT OLTx (p =0,0001) No LT Padua s treatment algorithm Cillo et al, PlosOne 2013, February 2013 Volume 8 Issue 2 e57249

19 Prospective study (December 2009 December 2010) 42 HCC patients ineligible for liver resection and/or percutaneous ablation RESULTS: Laparoscopic MW ablation is a safe and effective therapeutic option for selected HCC patients 94% had a CR whoat are 3 months ineligible follow-up for liver resection and/or percutaneous ablation No perioperative mortality Overall morbidity rate was 24% Survival P = year survival rate: 79% 2-year recurrence rate: 55% Recurrenc e P = Using propensity score analysis (28 MW, 28 RF) (P = 0.03) 2-year recurrence rate: MW: 55% RF: 77% Cillo U et al, HPB 2014, 16,

20 AISF Position Paper 2013: Any role for LA? Digestive and Liver Disease 45 (2013)

21 RACCOMANDAZIONI MULTISOCIETARIE ITALIANE (AISF, AIOM, IT-HPBA, SIC, SIRM, SITO) PER LA GESTIONE CLINICA INTEGRATA DEL PAZIENTE CON EPATOCARCINOMA Raccomandazioni Italiane Multisocietarie HCC_2016

22 Raccomandazioni Italiane Multisocietarie HCC_2016

23 Termoablazione Laparoscopica HCC S1 su cirrosi CHILD-C PBS ripetute

24 RE PRE M,65 yrs CT: Sg VIII 20 e 27 mm Sg VI 30 mm

25 RE PRE MW ablation Sg VIII 6 min 40 W Sg VI 5 min 40 W

26 RE POST

27 POST POST

28 FOCUS ABLAZIONI VLS HCC RICOVERO <3GG

29 LLR 1673 for HCC LLA for Padova HCC 2004 experience Baseline patient characteristics LengthCPT of stay score 3 days 993 (59,4%) LLA for HCC LLA Age 64 (25-88) Gender 85% MALE Portal hypertension 56% Ascites 17,8% Varices Esophageal 31,2% Splenomegaly 44,0% Cause of cirrhosis Hepatitis B 17,1% Hepatitis C 52,7% Alcool 24,1% Others 6,1% ECOG 0 86,1% ECOG 1 13,9% Previous Treatment 58,2% Liver Resection 6,1% Liver Ablation 43,2% TACE 38,3% Others 2,2% Cillo unpublished data

30 LLR 1673 for HCC LLA for Padova HCC 2004 experience Baseline patient characteristics LengthCPT of stay score 3 days 993 (59,4%) LLA for HCC LLA INR 1,17 (0,54-3,53) Creatinine (mg/dl) 0,83 (0,46-5,5) Bilirubin (mg/dl) 1,15 (0,19-7,74) Platelet count (10^3 plateles) 96 (18-720) Alpha-fetoprotein (ng/ml) 11,4 (0, ) Median size of nodules 25 (6-120) Single nodule 46,5% Multinodular 53,5% CHILD PUGH A 72,5% CHILD PUGH B 26,5% CHILD PUGH C 1,0% CHILD PUGH A vs B 72,5% - 27,5% BCLC 0 8,2% BCLC A 53,4% BCLC B 26,4% BCLC C 11,1% BCLC D 0,9% BCLC A vs B 61,6% - 38,4% MELD <10 vs 10 53,4% - 46,6% MELD cont. 9 (6-25) Presence of Metastases 0,08% Vascular Invasion 10,3% Cillo unpublished data

31 LLR 1673 for HCC LLA for Padova HCC 2004 experience Baseline patient characteristics LengthCPT of stay score 3 days 993 (59,4%) LLA for HCC LLA Median Operative Time 75 (25-700) IntraOP Blood Loss (ml) 0 (0-1800) Blood Transfusions 1,2% ASA 2 vs 3 51,8% - 48,2% MORBIDITY No PO complications 83,9% Clavien-Dindo 2 15,9% Clavien-Dindo 3 0,2% Length of stay (days) 2 (1-3) In Hospital mortality 0% 30 day mortality 0,2% 60 day mortality 0,7% 90 day mortality 1,8% Access to Liver Transplantation 13,1% (130) Cillo unpublished data

32 FOCUS ABLAZIONI VLS MTS RICOVERO <3GG

33 LLR for HCC Padova experience Baseline patient characteristics Length CPT of score stay 3 days 86 LLA for Metastases (50%) LLA for Metastases CRLM MBC Other Age 67(34-85) 56 (31-70) 64 (44-81) Gender 64,7% MALE - 37,5% MALE ECOG 0 88,2% 100% 100% ECOG 1 11,8% 0% 0% Previous Treatment 70,6% 33,3% (6) 25% (8/8) Liver Resection 41,2% (7) 5,5% (1) 0% Liver Ablation 41,2% (7) 27,8% (5) 25% (8/8) TACE 5,9% (1) 0% 0% Others 0% 0% 0% INR 1,10 (1-1,86) 1,01 (0,92-1,13) 1,05 (1-1,22) Creatinine (mg/dl) 0,86 (0,69-1,15) 0,66 (0,55-1) 0,89 (0,66 1,24) Bilirubin (mg/dl) 0,55 (0,26-1,19) 0,70 (0,10-1,04) 0,63 (0,39 1,09) Platelet count (10^3 plateles) 239 ( ) 236 ( ) 190 ( ) Median size of nodules 22 (14-64) 20 (10-50) 30 (15-57) Single nodule 41,2% (7/17) 16,7% (3/18) 62,5% (5/8)

34 LLR 86 for LLA HCC for Metastases Padova experience Baseline patient characteristics 43 (50%) LLA for Metastases Length of stay 3 days 17 CRLM MBC Other Median Operative Time 120 (30-270) 70 (30 165) 60 (50-120) IntraOP Blood Loss (ml) Blood Transfusions 0% 0% 0% ASA 2 vs 3 84,6% - 13,6% 93% - 7% 75% - 25% MORBIDITY No PO complications 100% 100% 100% Clavien-Dindo 2 0% 0% 0% Clavien-Dindo 3 0% 0% 0% Length of stay (days) 2 (1 3) 1 (1 3) 2 (1 3) In Hospital mortality 0% 0% 0% 30 day mortality 0% 0% 0% 60 day mortality 0% 0% 0% 90 day mortality 0% 0% 0%

35 Padova Experience st August Liver Resection

36 Padova Experience st August Laparotomic LR Laparoscopic LR

37 Fast-track

38 Fast-track

ERAS main goal >>> Enhance Functional Recovery 1) Adequate pain control 2) Tolerance of solid food (for at least 24 h) 3) Independently mobile 4) Normal or

39 ERAS main goal >>> Enhance Functional Recovery 1) Adequate pain control 2) Tolerance of solid food (for at least 24 h) 3) Independently mobile 4) Normal or decreasing Bilirubin Levels 5) No intravenous fluids GROUP A (95 PTS): open LR PRE-ERAS period GROUP B (55 PTS): laparoscopic minor LR GROPU C (57 PTS): open LR in ERAS period

42 LAPAROSCOPIC APPROACH performed according to fast-track principles Confirms superiority in terms of Perioperative outcome in patients undergoing Minor resections for HCC

43 FOCUS RESEZIONI VLS HCC RICOVERO<3GG

44 LLR for HCC Padova experience Baseline patient characteristics LengthCPT of stay score 3 days 222 LLR for HCC th April (26,1%) LLR for HCC th April LLR AGE 62 (32-82) GENDER 76% MALE Portal hypertension 34,5% (20/58) Ascites 1,7% (1/58) Varices Esophageal 27,6% (16/58) Splenomegaly 22,4% (13/58) Cause of cirrhosis Hepatitis B 15,5% Hepatitis C 43,1% Alcool 25,9% Others 15,5% ECOG 0 87,9% ECOG 1 12,1% Previous Treatment 43,1% Liver Resection 1,7% Liver Ablation 27,6% TACE 22,4% Others 0% Cillo unpublished data

45 LLR for HCC Padova experience Baseline patient characteristics LengthCPT of stay score 3 days 222 LLR for HCC th April (26,1%) LLR for HCC th April LLR INR 1,14 (0,92-1,47) Creatinine (mg/dl) 0,84 (0,5-1,4) Bilirubin (mg/dl) 0,86 (0,26-4,0) Platelet count (10^3 plateles) 139 (38-295) Alpha-fetoprotein (ng/ml) 14,5 (1, ) Median size of nodules (mm) 30 (10-120) Single nodule 48,3% Multinodular 51,7% CHILD PUGH A 86,2% CHILD PUGH B 13,8% CHILD PUGH C 0% CHILD PUGH A vs B 86,2% - 13,8% BCLC 0 5,2% BCLC A 56,9% BCLC B 37,9% BCLC C 0% BCLC D 0% BCLC A vs B 62,1% - 37,9% MELD <10 vs 10 70,2% - 29,8% MELD cont. 8 (6-15) Presence of Metastases 0% Vascular Invasion 6,9% (4)

46 222 LLR LLR for for HCC HCC 2004 Padova 30th experience April 2017 Baseline patient characteristics 58 (26,1%) LLR for HCC th April 2017 Length of stay 3 days 58 LLR Median operative time 142 (50-405) Conversion rate 0% IntraOP Blood Loss (ml) 0 (0-1800) Blood Transfusions 3,4% (2/58) ASA 2 vs 3 60% - 40% Type of liver resection Wedge 36,2% (21) Wedge + Ablation 36,2% (21) Segmental 8,6% (5) Segmental + Ablation 10,4% (6) Lateral Segmentectomy 8,6% (5) Major Hepatectomy 0% Cillo unpublished data

47 222 LLR for HCC th April (26,1%) LLR for HCC th April 2017 Length of stay 3 days 58 LLR MORBIDITY No PO complications 86,2% (50/58) Clavien-Dindo 2 23,8% (8/58) Clavien-Dindo 3 0% Margin Status R0 89,6% (52/58) R1 10,4% (6/58) EARLY OUTCOME 58 LLR Length of stay (days) 3 (1-3) In Hospital mortality 0% 30 day mortality 0% 60 day mortality 0% 90 day mortality 0% Access to Liver Transplantation 5,2% (3/58)

50 FOCUS RESEZIONI VLS MTS RICOVERO <3GG

51 LLR for HCC Padova experience Baseline patient characteristics Length CPT of score stay 3 days 96 LLR for Metastases (20,8%) LLR for Metastases CRLM MBC Other Age 73 (49-82) 60 (32-62) 55 (34-74) Gender 75% MALE - 60% MALE ECOG 0 100% 100% 100% ECOG 1 0% 0% 0% Previous Treatment 0% 28,6% (2/7) 20% (1/7) Liver Resection 0% 0% 20% (1/7) Liver Ablation 0% 28,6% (2/7) 0% TACE 0% 0% 0% Others 0% 0% 0% INR 1,04 (0,97-1,30) 1,03 (1-1,1) 1,04 (1-1,1) Creatinine (mg/dl) 0,90 (0,52-1,22) 0,70 (0,6-1,02) 0,79 (0,64 1,02) Bilirubin (mg/dl) 0,75 (0,37-2,09) 0,56 (0,3-0,84) 1,03 (0,51 2,75) Platelet count (10^3 plateles) 196 ( ) 227 ( ) 231 ( ) Median size of nodules 20 (6-30) 30 (12-40) 20 (11-30) Single nodule 62,5% (5/8) 57,1% (4/7) 40% (2/5)

52 LLR 96 for LLR HCC for Metastases Padova experience Baseline patient characteristics 20 (20,8%) LLR for Metastases Length of stay 3 days 8 CRLM MBC Other Median Operative Time 160 (85-245) 160 (55-235) 170 ( ) IntraOP Blood Loss (ml) 0 (0-150) 0 (0-100) 0 (0-100) Blood Transfusions 0% 0% 0% Conversion rate 0% 0% 0% ASA 2 vs 3 62,5% - 37,5% 100% - 0% 100% - 0% Type of liver resection Wedge 25% 28,55% (2/7) 0% Wedge + Ablation 75% 14,3% (1/7) 40% (2/5) Segmental 0% 14,3% (1/7) 40% (2/5) Segmental + Ablation 0% 0% 0% Lateral Segmentectomy 0% 28,55% (2/7) 20% (1/5) Major Hepatectomy 0% 14,3% (1/7) 0%

53 96 LLR for Metastases (20,8%) LLR for Metastases Length of stay 3 days 8 CRLM MBC Other MORBIDITY No PO complications 100% 100% 100% Clavien-Dindo 2 0% 0% 0% Clavien-Dindo 3 0% 0% 0% Margin Status R0 75% (6/8) 71,4% (5/7) 100% R1 25% (2/8) 28,6% (2/7) 0% EARLY OUTCOME 8 CRLM MBC Other Length of stay (days) 3 (2-3) 3 (2-3) 3 (2-3) In Hospital mortality 0% 0% 0% 30 day mortality 0% 0% 0% 60 day mortality 0% 0% 0% 90 day mortality 0% 0% 0%

55 FOCUS RESEZIONI VLS BENIGNI E ALTRO RICOVERO <3GG

56 LLR for HCC Padova experience Baseline patient characteristics Length CPT of score stay 3 days 77 LLR for Benign lesion and Other (35,1%) LLR for Benign lesion and Other LLR Age 48 (23-71) Gender 18,5% MALE ECOG 0 96,3% (26/27) ECOG 1 3,7% (1/27) Previous Treatment 7,4% (2/27) Liver Resection 3,7% Liver Ablation 3,7% TACE 3,7% Others 0% INR 1,06 (0,92-1,64) Creatinine (mg/dl) 0,75 (0,5-1,21) Bilirubin (mg/dl) 0,74 (0,2-1,6) Platelet count (10^3 plateles) 233 (67-373) Median size of nodules 45 (5-95) Single nodule 70,4%

57 LLR for HCC Padova experience Baseline patient characteristics 77 LLR for Benign lesion and Other (35,1%) LLR for Benign lesion and Other Length of stay 3 days 27 LLR Median Operative Time 160 (60-485) IntraOP Blood Loss (ml) 0 (0-450) Blood Transfusions 0% Conversion rate 0% ASA 2 vs 3 87% - 13% Type of liver resection Wedge 40,7% (11) Wedge + Ablation 7,4% (2) Segmental 30% (7) Segmental + Ablation 0% Lateral Segmentectomy 22,2% (6) Major Hepatectomy 3,7% (1)

58 77 LLR for Benign lesion and Other (35,1%) LLR for Benign lesion and Other Length of stay 3 days 27 LLR MORBIDITY No PO complications 96,3% (26/27) Clavien-Dindo 2 3,7% (1/27) Clavien-Dindo 3 0% Margin Status R0 88,8% (24/27) R1 11,2% (3/37) EARLY OUTCOME 27 LLR Length of stay (days) 3 (1-3) In Hospital mortality 0% 30 day mortality 0% 60 day mortality 0% 90 day mortality 0%

59 Extreme Minimally Invasive Liver Surgery: Single port left lateral resection for CCA

60 Schnitzbauer, Lang et al Annals of Surgery Volume 255, Number 3, March 2012

61 University of Padova Experience: From ALPPS to LAPS Cillo, Ann Surg 2015

62 University of Padova Experience: LAPS step 2 FLR 390 cc FLR 693 cc 10 days FLR/BW ratio 0,52% FLR/BW ratio 0,92% Extended Right Hepatectomy Diaphragm Resection U. Cillo, personal experience 2014

64 Totally LAPS STEP 1 Duration: 170 min NO blood loss NO ICU Stay NO Complications STEP 2 Duration: 630 min blood loss: 700cc NO transfusions ICU Stay: 2 days NO Complications STEP 1 (3 days) Home Stay (15 days) STEP 2 (7 days)

65 Totally LAPS STEP 1 (HOSPITAL STAY 3 DAYS) STEP 2 (HOSPITAL STAY 7 DAYS) 44 days FLR/BW: 0,49 FLR/BW: 1,5 FLR/BW: 0,96 FLR: 349,72 cc 90,4% 197% FLR: 666 cc FLR: 1041,28 cc

positively many felt that the real recovery from

67 ... Patients approached surgery with a sense of renewed hope involvement with the ERP was viewed positively many felt that the real recovery from surgery began at home and so felt positive about having an early discharge

Surgical management of HCC. Evangelos Prassas Hepatobiliary and Pancreatic Surgery / Liver Transplantation Kings College Hospital / London

Surgical management of HCC. Evangelos Prassas Hepatobiliary and Pancreatic Surgery / Liver Transplantation Kings College Hospital / London Surgical management of HCC Evangelos Prassas Hepatobiliary and Pancreatic Surgery / Liver Transplantation Kings College Hospital / London Global distribution of HCC and staging systems WEST 1. Italy (Milan,