A  Prospec*ve  Randomized  Trial  Comparing  Percutaneous  Local  Abla*ve  Therapy  and  Par*al  Hepatectomy  for  Small  Hepatocellular  Carcinoma  

RFS  Journal  Primer  

BOTTOM  LINE  •  A  prospective   randomized   trial   on  180  patients  with   solitary  HCC  <5cm   found  percutaneous   local  

ablative  therapy  (PLAT)  to  be  as  effective  as  surgical  resection.      MAJOR  POINTS    •  The  1-­‐,  2-­‐,  3-­‐,  and  4-­‐year  overall  survival  rates  and  disease-­‐free  survival  rates  were  not  signiOicantly  

different  between  the  PLAT  and  surgical  resection  groups.  •  Surgical  resection  had  more  major  complications  (50/90  patients)  vs  PLAT  (3/71)  •  Pain:  all  surgical  patients  required  analgesics.  Only  16  patients  required  analgesics  after  PLAT.  •  Longer  hospital  stay  for  surgical  patients  (19.70  vs  9.18  days).  

CRITICISM    

•  Post  randomization  exclusion  of  19/90  PLAT  patients.  Withdrew  consent.  

•  Mean  follow  up  of  just  beyond  2  years.  

•  Relatively  small  sample  size  (180  patients)  

Quick  Summary  

SINGLE  CENTER  PROSPECTIVE  RANDOMIZED  TRIAL  •  180  patients:  90  received  PLAT,  90  had  surgical  resection:  Nov  1999  –  June  

2004.  

INCLUSION  CRITERIA  •  Age  18-­‐75  •  Solitary  HCC  <  5cm  in  diameter  •  No  extrahepatic  metastasis  or  major  portal/hepatic  vein  invasion  •  Pugh-­‐Child  Class  A  •  ICG-­‐R15  <  30%  •  Patients  suitable  for  either  intervention  EXCLUSION  CRITERIA  •  Previous  HCC  treatment  •  Platelet  count  <40,000,  history  of  encephalopathy,  ascites  refractory  to  diuretics,  

variceal  bleeding    

Study  design  

•  To  compare  percutaneous  local  ablative  therapy  with  surgical  resection  in  the  treatment  of  solitary  and  small  hepatocellular  carcinoma.    

 

Purpose  

http://www.nature.com/modpathol/journal/v27/n3/Oig_tab/modpathol201380f5.html  

Radiofrequency  Ablation  •  RF  2000;  Radio-­‐Therapeutics,  Mountain  View,  Ca),  needle  electrode  with  15-­‐gauge  insulated  

cannula  with  10  hook-­‐shape  expandable  electrode  tines  with  a  diameter  of  3.5  cm  at  expansion.  

•  Local  anesthetics,  intravenous  sedation,  or  lumbar  epidural  anesthesia  •  Start  with  10  W  of  power,  increase  10  W/min  à  90  W  •  Apply  until  marked  increase  in  impedance  or  15  minutes  •  Up  to  3  applications  if  necessary  •  More  placement  of  needles  if  tumor  >3cm  or  initial  unsatisfactory  placement  •  Goal:  hyperechoic  area  covering  larger  area  than  HCC.    Follow-­‐up  •  Dual-­‐phase  spiral  CT:  at  4  weeks  post-­‐op  à  every  2  months  for  Oirst  2years  à  ever  3  months  •  LFTs,  AFPs  at  each  visit.  Chest  X-­‐ray  every  6  months.  •  If  residual  viable  tumor,  additional  RFA  or  PEI.  •  If  still  present  after  repeat  treatments,  TACE  was  performed.  

Interven7on:  RFA  

•  General  anesthesia  •  Right  subcostal  incision  with  midline  extension  •  Couinaud  liver  segment  resection:  

•  1  segment  resection:  69  patients  

•  2  segment  resection:  16  patients  

•  3  or  more  segments:  3  patients  

•  Goal:  resection  margin  of  at  least  1  cm  •  Clamp/unclamp  time  of  10  min/5  min.  •  Hemostasis  of  raw  liver  surface  with  suturing  and  Oibrin  glue  

Interven7on:  Surgical  Resec7on  

Outcome    

Intent-­‐to-­‐Treat:  19  PLAT  patients  withdrew  consent;  underwent  surgical  resection  •  1-­‐,  2-­‐,  3-­‐,  and  4-­‐year  overall  survival  rates  

•  PLAT:  94.4%,  79.8%,  68.6%,  65.9%  

•  Resection:  93.3%,  82.3%,  73.4%,  64.0%  

•  1-­‐,  2-­‐,  3-­‐,  and  4-­‐year  disease-­‐free  survival  rates    •  PLAT:  90.8%,  68.6%,  59.8%,  48.2%  

•  Resection:  86.6%,  76.8%,  69.0%,  51.6%  

•  No  signiOicant  difference  after  post-­‐randomization  exclusion  •  No  statistically  signiOicant  difference  in  overall  &  disease-­‐free  survival  between  the  two  groups  •  No  statistically  signiOicant  difference  in  overall  &  disease-­‐free  survival  when  analyzing  tumors  

<3cm  and  3.1-­‐5.0  cm.    •  Surgical   resection  major   complications   (50/90   patients):   Liver   failure,   GI   bleed,   moderate/

severe  ascites,  persistent  jaundice  >30  days  after  surgery.  •  PLAT  major  complications  (3/71):  mild  burn  at  electrode  pad  sites.    •  Pain:  all  surgical  patients  required  analgesics.  Only  16  patients  required  analgesics  after  PLAT.  •  Longer  hospital  stay  for  surgical  patients  (19.70  vs  9.18).  

Credits  

SUMMARY  BY:    Harout  Dermendjian  MS3  Keck  School  of  Medicine  University  of  Southern  California    FULL  CITATION:  Chen  MS,  Li  JQ,  Zheng  Y,  et  al.  A  prospective  randomized  trial  comparing  percutaneous  local  ablative  therapy  and  partial  hepatectomy  for  small  hepatocellular  carcinoma.  Ann  Surg.  2006;  243:  321-­‐328.  

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