Lars  Påhlman Dept.  Surgery,  Colorectal  unit, University  Hospital,  Uppsala,  Sweden Laparoscopic  resection;  colorec...
Laparoscopic  Colorectal  Cancer  Surgery <ul><li>What  type  of  problems ? </li></ul><ul><li>Is  it  a  good  cancer  op...
Laparoscopic  Colorectal  Cancer  Surgery <ul><li>According  to  available </li></ul><ul><li>data  from  uncontrolled  tri...
Laparoscopic  Colorectal  Cancer  Surgery <ul><li>The  problem  is  the </li></ul><ul><li>historical  control </li></ul><u...
Laparoscopic  Colorectal  Cancer  Surgery <ul><li>Another  problem  is  the </li></ul><ul><li>selection  bias </li></ul>
Laparoscopic  Colorectal  Cancer  Surgery <ul><li>A  third  problem  is; </li></ul><ul><li>What  is  a  </li></ul><ul><li>...
Laparoscopic  Colorectal  Cancer  Surgery <ul><li>What  is  a  laparoscopic  procedure ? </li></ul><ul><li>Inspection  +  ...
 
Port-site  recurrence <ul><li>Incidence </li></ul><ul><li>First  reports  in  1993 </li></ul><ul><li>Literature  confusing...
Port-site  recurrence <ul><li>Conclusion </li></ul><ul><li>Literature  so  confusion </li></ul><ul><li>Can  just  be  a  m...
Port-site  recurrence <ul><li>The  true  incidence </li></ul><ul><li>? </li></ul>
Laparoscopic  Colorectal  Cancer  Surgery <ul><li>‘ Surrogate’  end-points </li></ul><ul><li>Early  mobilisation </li></ul...
 
Laparoscopic  Colorectal  Cancer  Surgery <ul><li>Short  term  end-points </li></ul><ul><li>Open  Lap </li></ul><ul><li>Ea...
Laparoscopic  Colorectal  Cancer  Surgery <ul><li>The  Barcelona  trial </li></ul><ul><li>November 1993  -  July 1998 </li...
<ul><li>442  eligible;  223  excluded </li></ul><ul><li>Lap Open </li></ul><ul><li>219  randomised;  111   108   </li></ul...
Laparoscopic  Colorectal  Cancer  Surgery The  Barcelona  Trial Overall survival
Laparoscopic  Colorectal  Cancer  Surgery The  Barcelona  Trial Cancer  specific survival
C O L O R COLOR STUDY GROUP Short-term results C O lon cancer : L aparoscopic   or O pen R esection  ?
<ul><li>Three  years  </li></ul><ul><li>Disease  Free  Survival </li></ul>Primary  endpoint C O L O R
Randomisation <ul><li>Randomised:  1246 </li></ul><ul><li>Exclusions:    138 </li></ul><ul><li>Total: 1108 </li></ul><ul><...
Stage <ul><li>Stage  I </li></ul><ul><li>II </li></ul><ul><li>III </li></ul><ul><li>Lap Open Total </li></ul><ul><li>24.0%...
Conversion  rate <ul><li>Peroperative  17.8% </li></ul><ul><li>Preoperative   1.4% </li></ul>C O L O R
Reasons  for  conversion <ul><li>Fixation/invasion  n = 31 </li></ul><ul><li>Large  tumour  n = 10 </li></ul><ul><li>Adhes...
Early  conclusions  from   <ul><li>Laparoscopic  colectomy  for  cancer </li></ul><ul><li>Based  upon  ‘surrogate’  end-po...
Laparoscopic  Colorectal  Cancer  Surgery <ul><li>How  to  use  data </li></ul><ul><li>from  ongoing </li></ul><ul><li>tri...
Laparoscopic  Colorectal  Cancer  Surgery <ul><li>Ongoing  trials </li></ul><ul><li>Multicentre </li></ul><ul><li>Trial  N...
Laparoscopic  surgery  for  colon  cancer Meta - analysis  I  (Hazard  ratio) Overall  survival  (OS)  and  disease-free  ...
Laparoscopic  surgery  for  colon  cancer Meta - analysis  I  (Overall  data) Overall  survival (OS)  and  disease-free  s...
Laparoscopic  surgery  for  colon  cancer Meta - analysis  I  (Stage  by  stage  data) Overall  survival (OS)
Laparoscopic  surgery  for  colon  cancer Meta - analysis  I  (Stage  by  stage  data) Disease-free  survival (DS)
Laparoscopic  Colorectal  Cancer  Surgery <ul><li>Conclusion  I </li></ul><ul><li>The  1st  meta-analysis </li></ul><ul><l...
Laparoscopic  Colorectal  Cancer  Surgery <ul><li>Conclusion  II </li></ul><ul><li>Later  all  trials </li></ul><ul><li>(C...
C O L O R
C O L O R
 
Laparoscopic  Colorectal  Cancer  Surgery <ul><li>Long  term  end-points </li></ul><ul><li>Open  Lap </li></ul><ul><li>Ove...
Laparoscopic  Colorectal  Cancer  Surgery <ul><li>Conclusion  III </li></ul><ul><li>According  to  the  meta-analysis; </l...
Laparoscopic  Colorectal  Cancer  Surgery <ul><li>Conclusion  IV </li></ul><ul><li>But ! </li></ul><ul><li>Open  surgery  ...
Laparoscopic  Colorectal  Cancer  Surgery <ul><li>Conclusion  V </li></ul><ul><li>The  selection  bias ! </li></ul><ul><li...
Laparoscopic  Colorectal  Cancer  Surgery <ul><li>Conclusion  VI </li></ul><ul><li>So  far  the  results  are  only  appli...
 
Laparoscopic  Rectal  Cancer  Surgery <ul><li>Ongoing  trials </li></ul><ul><li>Multicentre </li></ul><ul><li>Trial  No. <...
Laparoscopic  Rectal  Cancer  Surgery <ul><li>What  do  we  know  so  far </li></ul><ul><li>Open  Lap </li></ul><ul><li>CR...
Laparoscopic  Rectal  Cancer  Surgery <ul><li>According  to  available </li></ul><ul><li>data  from  uncontrolled  trials ...
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MCC - Slide 13

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MCC - Slide 13

  1. 1. Lars Påhlman Dept. Surgery, Colorectal unit, University Hospital, Uppsala, Sweden Laparoscopic resection; colorectal cancer
  2. 2. Laparoscopic Colorectal Cancer Surgery <ul><li>What type of problems ? </li></ul><ul><li>Is it a good cancer operation ? </li></ul><ul><li>Selection bias </li></ul><ul><li>What is a laparoscopic procedure </li></ul><ul><li>Surrogate end-points </li></ul><ul><li>Randomised trials </li></ul>
  3. 3. Laparoscopic Colorectal Cancer Surgery <ul><li>According to available </li></ul><ul><li>data from uncontrolled trials </li></ul><ul><li>it looks like laparoscopic </li></ul><ul><li>surgery is appropriate </li></ul>
  4. 4. Laparoscopic Colorectal Cancer Surgery <ul><li>The problem is the </li></ul><ul><li>historical control </li></ul><ul><li>which always is difficult </li></ul><ul><li>to interpret </li></ul>
  5. 5. Laparoscopic Colorectal Cancer Surgery <ul><li>Another problem is the </li></ul><ul><li>selection bias </li></ul>
  6. 6. Laparoscopic Colorectal Cancer Surgery <ul><li>A third problem is; </li></ul><ul><li>What is a </li></ul><ul><li>laparoscopic procedure </li></ul>
  7. 7. Laparoscopic Colorectal Cancer Surgery <ul><li>What is a laparoscopic procedure ? </li></ul><ul><li>Inspection + release adhesions </li></ul><ul><li>Mobilisation </li></ul><ul><li>Division of major vessels </li></ul><ul><li>Division of the bowel </li></ul><ul><li>Creation of an anastomosis </li></ul>
  8. 9. Port-site recurrence <ul><li>Incidence </li></ul><ul><li>First reports in 1993 </li></ul><ul><li>Literature confusing </li></ul><ul><li>0 % to > 20 % </li></ul><ul><li>Other malignancies </li></ul>
  9. 10. Port-site recurrence <ul><li>Conclusion </li></ul><ul><li>Literature so confusion </li></ul><ul><li>Can just be a matter of </li></ul><ul><li>bad surgical technique </li></ul>
  10. 11. Port-site recurrence <ul><li>The true incidence </li></ul><ul><li>? </li></ul>
  11. 12. Laparoscopic Colorectal Cancer Surgery <ul><li>‘ Surrogate’ end-points </li></ul><ul><li>Early mobilisation </li></ul><ul><li>Short hospital stay </li></ul><ul><li>Less pain </li></ul><ul><li>Better cosmetic results </li></ul>
  12. 14. Laparoscopic Colorectal Cancer Surgery <ul><li>Short term end-points </li></ul><ul><li>Open Lap </li></ul><ul><li>Early mobilisation - + </li></ul><ul><li>Short hospital stay - + </li></ul><ul><li>Operation time (+) - </li></ul><ul><li>Less pain - + </li></ul><ul><li>Better cosmetic results - + </li></ul><ul><li>Postop. ileus - + </li></ul><ul><li>Postop. Complications = </li></ul>
  13. 15. Laparoscopic Colorectal Cancer Surgery <ul><li>The Barcelona trial </li></ul><ul><li>November 1993 - July 1998 </li></ul>
  14. 16. <ul><li>442 eligible; 223 excluded </li></ul><ul><li>Lap Open </li></ul><ul><li>219 randomised; 111 108 </li></ul><ul><li>11 metastases; 5 6 </li></ul><ul><li>2 lost to follow-up 1 1 </li></ul><ul><li>206 completed trial 105 101 </li></ul><ul><li>The Lancet; 359:2224-2229, 2002 </li></ul>Laparoscopic Colorectal Cancer Surgery The Barcelona Trial
  15. 17. Laparoscopic Colorectal Cancer Surgery The Barcelona Trial Overall survival
  16. 18. Laparoscopic Colorectal Cancer Surgery The Barcelona Trial Cancer specific survival
  17. 19. C O L O R COLOR STUDY GROUP Short-term results C O lon cancer : L aparoscopic or O pen R esection ?
  18. 20. <ul><li>Three years </li></ul><ul><li>Disease Free Survival </li></ul>Primary endpoint C O L O R
  19. 21. Randomisation <ul><li>Randomised: 1246 </li></ul><ul><li>Exclusions: 138 </li></ul><ul><li>Total: 1108 </li></ul><ul><li>The trial was closed March 2003 </li></ul>C O L O R
  20. 22. Stage <ul><li>Stage I </li></ul><ul><li>II </li></ul><ul><li>III </li></ul><ul><li>Lap Open Total </li></ul><ul><li>24.0% 22.6% 23.3% </li></ul><ul><li>41.2% 44.4% 42.8% </li></ul><ul><li>34.5% 32.9% 33.7% </li></ul>C O L O R
  21. 23. Conversion rate <ul><li>Peroperative 17.8% </li></ul><ul><li>Preoperative 1.4% </li></ul>C O L O R
  22. 24. Reasons for conversion <ul><li>Fixation/invasion n = 31 </li></ul><ul><li>Large tumour n = 10 </li></ul><ul><li>Adhesions n = 8 </li></ul><ul><li>Bleeding n = 6 </li></ul><ul><li>Other n = 41 </li></ul>C O L O R
  23. 25. Early conclusions from <ul><li>Laparoscopic colectomy for cancer </li></ul><ul><li>Based upon ‘surrogate’ end-points ! </li></ul><ul><li>Safe </li></ul><ul><li>Takes longer </li></ul><ul><li>Less blood loss </li></ul><ul><li>Earlier recovery </li></ul>C O L O R C O L O R
  24. 26. Laparoscopic Colorectal Cancer Surgery <ul><li>How to use data </li></ul><ul><li>from ongoing </li></ul><ul><li>trials ? </li></ul><ul><li>2004 </li></ul>
  25. 27. Laparoscopic Colorectal Cancer Surgery <ul><li>Ongoing trials </li></ul><ul><li>Multicentre </li></ul><ul><li>Trial No. </li></ul><ul><li>Color (Europe) 1,200 </li></ul><ul><li>Classic (UK) 800 </li></ul><ul><li>Cost (US) 800 </li></ul><ul><li>Barcelona 200 </li></ul>
  26. 28. Laparoscopic surgery for colon cancer Meta - analysis I (Hazard ratio) Overall survival (OS) and disease-free survival (DFS)
  27. 29. Laparoscopic surgery for colon cancer Meta - analysis I (Overall data) Overall survival (OS) and disease-free survival (DS)
  28. 30. Laparoscopic surgery for colon cancer Meta - analysis I (Stage by stage data) Overall survival (OS)
  29. 31. Laparoscopic surgery for colon cancer Meta - analysis I (Stage by stage data) Disease-free survival (DS)
  30. 32. Laparoscopic Colorectal Cancer Surgery <ul><li>Conclusion I </li></ul><ul><li>The 1st meta-analysis </li></ul><ul><li>showed no difference in </li></ul><ul><li>disease free survival ! </li></ul>
  31. 33. Laparoscopic Colorectal Cancer Surgery <ul><li>Conclusion II </li></ul><ul><li>Later all trials </li></ul><ul><li>(Cost, Color, Classic) </li></ul><ul><li>showed no difference in </li></ul><ul><li>disease free survival ! </li></ul>
  32. 34. C O L O R
  33. 35. C O L O R
  34. 37. Laparoscopic Colorectal Cancer Surgery <ul><li>Long term end-points </li></ul><ul><li>Open Lap </li></ul><ul><li>Overall survival = </li></ul><ul><li>Disease - free survival = </li></ul><ul><li> </li></ul><ul><li>Incisionen hernias = </li></ul><ul><li>Adhesions (SBO) = </li></ul>
  35. 38. Laparoscopic Colorectal Cancer Surgery <ul><li>Conclusion III </li></ul><ul><li>According to the meta-analysis; </li></ul><ul><li>Laparoscopic surgery for </li></ul><ul><li>colon cancer could probably </li></ul><ul><li>be done outside trials ! </li></ul>
  36. 39. Laparoscopic Colorectal Cancer Surgery <ul><li>Conclusion IV </li></ul><ul><li>But ! </li></ul><ul><li>Open surgery for colon cancer </li></ul><ul><li>is still a valid option ! </li></ul>
  37. 40. Laparoscopic Colorectal Cancer Surgery <ul><li>Conclusion V </li></ul><ul><li>The selection bias ! </li></ul><ul><li>A minority of patients in the participating hospitals have been included in the trials ! </li></ul>
  38. 41. Laparoscopic Colorectal Cancer Surgery <ul><li>Conclusion VI </li></ul><ul><li>So far the results are only applicable on colon cancer ! </li></ul><ul><li>Therefore we need a new trial ! </li></ul>
  39. 43. Laparoscopic Rectal Cancer Surgery <ul><li>Ongoing trials </li></ul><ul><li>Multicentre </li></ul><ul><li>Trial No. </li></ul><ul><li>Classic (UK) 300 </li></ul><ul><li>Color II (Europe) 1.100 </li></ul><ul><li>Cost (US) 800 </li></ul>
  40. 44. Laparoscopic Rectal Cancer Surgery <ul><li>What do we know so far </li></ul><ul><li>Open Lap </li></ul><ul><li>CRM +ve No Yes </li></ul><ul><li>Nerve damage Less More </li></ul><ul><li>T4 - tumour Yes No </li></ul><ul><li>Low anastomosis OK Difficult </li></ul>
  41. 45. Laparoscopic Rectal Cancer Surgery <ul><li>According to available </li></ul><ul><li>data from uncontrolled trials </li></ul><ul><li>it looks like laparoscopic </li></ul><ul><li>surgery is appropriate </li></ul>

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