Presentation study protocol

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Presentation study protocol

  1. 1. PATHOLOGY PROTOCOL
  2. 2. <ul><li>INTRODUCTION </li></ul><ul><li>better prognosis colon cancer </li></ul><ul><li>better staging </li></ul><ul><li>basis of the study: </li></ul><ul><ul><li>ex vivo SLNM </li></ul></ul><ul><ul><li>pathology protocol </li></ul></ul>RATIONALE OF THE STUDY
  3. 3. RATIONALE OF THE STUDY <ul><li>high disease recurrence in pN0 colon cancer patients. </li></ul><ul><li>5-yr disease recurrence 5yr OS </li></ul><ul><ul><li>stage I 10% 90% </li></ul></ul><ul><ul><li>stage II 15-30% 75% </li></ul></ul><ul><li>~ 1150 pts yearly in the Netherlands </li></ul>
  4. 4. EnRoute  PROTOCOL SURGERY ex vivo SLNM
  5. 5. <ul><li>oncological colonic resection </li></ul><ul><li>ex vivo sentinel lymph node procedure </li></ul><ul><li>pathological examination </li></ul><ul><ul><li>standard H&E procedure </li></ul></ul><ul><ul><li>fine pathological analysis in pN0 patients </li></ul></ul>EnRoute  PROTOCOL
  6. 6. <ul><li>oncological colonic resection </li></ul><ul><li>ex vivo sentinel lymph node procedure </li></ul><ul><li>pathological examination </li></ul><ul><ul><li>standard H&E procedure </li></ul></ul><ul><ul><li>fine pathological analysis in pN0 patients </li></ul></ul>EnRoute  PROTOCOL
  7. 7. <ul><li>RIGHT HEMICOLECTOMY </li></ul><ul><li>suture marked </li></ul><ul><ul><li>a. ileocolica </li></ul></ul><ul><ul><li>a. colica dextra </li></ul></ul><ul><ul><li>right branch </li></ul></ul><ul><ul><li>a. colica media </li></ul></ul>SURGICAL RESECTIONS
  8. 8. <ul><li>LEFT HEMICOLECTOMY </li></ul><ul><li>suture marked </li></ul><ul><ul><li>left branch </li></ul></ul><ul><ul><li>a. colica media </li></ul></ul><ul><ul><li>a. colica sinistra </li></ul></ul>SURGICAL RESECTIONS
  9. 9. <ul><li>SIGMOID RESECTION </li></ul><ul><li>suture marked </li></ul><ul><ul><li>aa. sigmoidales </li></ul></ul><ul><ul><li>a. rectalis superior </li></ul></ul>SURGICAL RESECTIONS
  10. 10. <ul><li>oncological colonic resection </li></ul><ul><li>ex vivo sentinel lymph node procedure </li></ul><ul><li>pathological examination </li></ul><ul><ul><li>standard H&E procedure </li></ul></ul><ul><ul><li>fine pathological analysis in pN0 patients </li></ul></ul>EnRoute  PROTOCOL
  11. 11. <ul><li>AIM </li></ul><ul><li>more and probably more relevant LN’s </li></ul><ul><li>fine pathology only in SLN’s </li></ul><ul><li>(in pN0 patients) </li></ul>ex vivo SLNM
  12. 12. <ul><li>PROCEDURE </li></ul><ul><li>within 15 minutes following resection </li></ul><ul><li>performed by surgeon </li></ul><ul><ul><li>or by pathologist according to local facilities </li></ul></ul><ul><li>opening colon antimesenterial border </li></ul><ul><li>Patent-V blue, 1 ml in toto </li></ul><ul><li>submucosal injection, 5 min massage </li></ul><ul><li>formalin fixation within 15 minutes </li></ul>ex vivo SLNM
  13. 13. ex vivo SLNM preparation
  14. 14. ex vivo SLNM opening colon
  15. 15. ex vivo SLNM cleaning
  16. 16. ex vivo SLNM injection
  17. 17. ex vivo SLNM massage
  18. 18. ex vivo SLNM detection
  19. 19. ex vivo SLNM transportation
  20. 20. <ul><li>oncological colonic resection </li></ul><ul><li>ex vivo sentinel lymph node procedure </li></ul><ul><li>pathological examination </li></ul><ul><ul><li>standard H&E procedure </li></ul></ul><ul><ul><li>fine pathological analysis in pN0 patients </li></ul></ul>EnRoute  PROTOCOL
  21. 21. <ul><li>STANDARD H&E PROCEDURE </li></ul><ul><li>all lymph nodes (LN vs. SLN) </li></ul><ul><li>all lymph nodes in marked cassettes </li></ul><ul><li>blue vs non-blue </li></ul><ul><li>non-SLN bivalve </li></ul><ul><li>one H&E slide per level </li></ul> PATHOLOGY PROTOCOL
  22. 22. <ul><li>FINE PATHOLOGY </li></ul><ul><li>only in SLN, only in pN0 patients </li></ul><ul><li>definition and number of sentinel nodes (SLN)? </li></ul><ul><ul><li>the first three blue nodes nearest to the tumour </li></ul></ul><ul><ul><li>(defined by pathologist) </li></ul></ul> PATHOLOGY PROTOCOL
  23. 23. <ul><li>FINE PATHOLOGY </li></ul><ul><li>one SLN per cassette (marked) </li></ul><ul><li>inclusion according to size </li></ul><ul><ul><li><5mm in toto </li></ul></ul><ul><ul><li>5-10 bivalve </li></ul></ul><ul><ul><li>>10 4 sections </li></ul></ul> PATHOLOGY PROTOCOL
  24. 24. PATHOLOGY PROTOCOL <ul><li>FINE PATHOLOGY </li></ul><ul><li>pN0: all SLN’s studied at 3 levels </li></ul><ul><li>slides from each level HE and IHC </li></ul><ul><li>section interval 250 μ m </li></ul><ul><li>IHC: CK AE1/AE3, </li></ul><ul><li>CAM5.2, LU5 </li></ul>
  25. 25. PATHOLOGY PROTOCOL STEP 1 resection - fixation STEP 2 fixation – conv. H&E staining STEP 3 conv. H&E staining – IHC
  26. 26. PATHOLOGY PROTOCOL STEP 1 # # according to local facilities # FRESH SPECIMEN digital picture specimen variables - length colon segment - length tumour-base radix - total weight specimen - width mesocolon - size of the tumor - number of blue nodes - tumor specimen fixation protocol for at least 24h fixation protocol for at least 24h FIXED SPECIMEN ex vivo SLNM
  27. 27. PATHOLOGY PROTOCOL STEP 1 # # according to local facilities digital picture specimen variables - length colon segment - length tumour-base radix - total weight specimen - width mesocolon - size of the tumor - number of blue nodes - tumor specimen
  28. 28. PATHOLOGY PROTOCOL STEP 2 fixation protocol for at least 24h identification LNN ( ≥ 10 LNN) first 3 blue SL nodes nearest to the tumour other blue/non-blue LNN marked cassettes 1-3 marked cassettes >3 < 0.5 cm: in toto 0.5 < 1cm: bivalve > 1 cm: lamellate bivalve conventional H&E staining
  29. 29. PATHOLOGY PROTOCOL STEP 3 a. b. macrometastasis (pN+) <ul><ul><li>EXCLUSION CRITERIA </li></ul></ul><ul><ul><li>< 10 LNN </li></ul></ul><ul><ul><li>T4 </li></ul></ul><ul><ul><li>angioinvasion </li></ul></ul><ul><ul><li>colon perforation at presentation </li></ul></ul><ul><ul><li>obstruction at presentation </li></ul></ul>conventional H&E staining (all sections LNN 1 – 10) no macrometastasis (pN0) NO IHC staining H&E and IHC staining of all SLNs (max 3) detection of micrometastasis
  30. 30. PATHOLOGY PROTOCOL <ul><li>MICROMETASTATIC DISEASE </li></ul><ul><ul><li>definitions used in EnRoute  </li></ul></ul><ul><ul><li>- isolated tumor cells (ITC) </li></ul></ul><ul><ul><li>- micrometastasis (MM) </li></ul></ul>
  31. 31. PATHOLOGY PROTOCOL <ul><li>DEFINITIONS USED IN EnROUTE  </li></ul>Definitions used in the En Route  study Isolated Tumor Cells (ITCs) Micrometastases (MMs) size < 0.2 mm 0.2 – 2 mm localization no defined no defined detection method HES and/or IHC HES and/or IHC formal designation (present vs absent) pN0 i+ vs pN0 i - pN0 mi+ vs pN0 mi - EnRoute  if present pN0 micro+ pN0 micro+
  32. 32. <ul><li>PATHOLOGY PROTOCOL </li></ul><ul><li>pathology flow diagram available </li></ul><ul><li>pathology (e)CRF / PALGA </li></ul><ul><li>financial compensation </li></ul><ul><ul><li>€ 100,- per patient (all registered patients) </li></ul></ul><ul><li>protocol discussion “Pathologendagen ” </li></ul>PATHOLOGY PROTOCOL
  33. 33. <ul><li>ACKNOWLEDGEMENTS </li></ul><ul><li>Steering pathologists </li></ul><ul><ul><li>H. J. (Hans) van de Linden (JBZ) </li></ul></ul><ul><ul><li>P (Peet) Nooijen (JBZ) </li></ul></ul><ul><ul><li>V.T.H.B.M. (Vincent) Smit (LUMC) </li></ul></ul><ul><li>Educational Grant: </li></ul>PATHOLOGY PROTOCOL

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