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W. Douglas Wong, M.D. Chief,Colorectal Service Memorial Sloan Kettering Cancer Center Professor of Surgery Cornell Univ

Ultra-Low Sphincter Saving Procedures - Re-defining the inferior resection limit. 4 th East – West Colorectal Days Hungary Oct. 16-18, 2008. W. Douglas Wong, M.D. Chief,Colorectal Service Memorial Sloan Kettering Cancer Center Professor of Surgery Cornell University Medical School.

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W. Douglas Wong, M.D. Chief,Colorectal Service Memorial Sloan Kettering Cancer Center Professor of Surgery Cornell Univ

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  1. Ultra-Low Sphincter Saving Procedures - Re-defining the inferior resection limit 4th East – West Colorectal Days Hungary Oct. 16-18, 2008 W. Douglas Wong, M.D. Chief,Colorectal Service Memorial Sloan Kettering Cancer Center Professor of Surgery Cornell University Medical School

  2. Sphincter preserving surgery should be considered the standard for the majority of low rectal cancers

  3. How much distal margin do you need? • 5 cm rule* • 2 cm rule** • “end of the 2 cm rule” *Williams et al. Reappraisal of the 5cm rule of distal excision for carcinoma of the rectum. Br. J Surg. 1983;70:150-154. **Pollett et al. The relationship between the extent of distal clearance and survival and local recurrence rates after curative anterior resection for carcinoma of the rectum. Ann Surg. 1983;198:159-163

  4. What is an adequate distal margin for sphincter sparing rectal resection? MSKCC Studies Whole Mount Pathologic Analysis ( Annals of Surgery 2007) Distal Margin Analysis Study ( Unpublished 2008 ) Coloanal / Intersphincteric Study ( Submitted 2008 )

  5. Study # 1 A Prospective Pathologic Analysis Using Whole-Mount Sections of Rectal Cancer Following Preoperative Combined Modality TherapyImplications for Sphincter Preservation Jose Guillem, David Chessin, Jinru Shia, Arief Suriawinata, Elyn Riedel, Harvey Moore, Bruce Minsky, and W. Douglas Wong Annals of Surgery 2007;245(1):88-93

  6. Aims of the Study • To use whole mount pathologic analysis to characterize microscopic patterns of residual disease • Circumferential margins • Distal resection margins • To identify clinicopathologic factors associated with residual disease

  7. Methodology • 109 patients prospectively accrued with ERUS staged locally advanced rectal cancer (T2-T4 and /or N1) • Median distance of 7 cm. from anal verge • Preoperative chemoradiation followed by TME based resection • Comprehensive whole mount pathologic analysis was performed

  8. Results • Sphincter preserving resection was feasible in 87 patients (80%) • Distal margins negative in all 109 pts • Median 2.1 cm; range 0.4 – 10 cm • Intramural extension beyond gross mucosal edge of residual tumor was only in 2 patients (1.8 %) • Both < .95 cm • No positive circumferential margins although 6 were less that 1 mm • Median 10 mm; range 1 - 28 mm • On multivariate analysis, residual disease was observed more frequently in distally located tumors < 5 cm from the anal verge (p=.03)

  9. Distal Margin Rectal Cancer Impact of distal margin • MSK1: Whole mount analysis of 87 locally advanced RC after neoadjuvant CMT and LAR • No positive margins • 2.2% had intramural extension beyond mucosal edge of tumor 9.5mm 3mm 1. Guillem JG, Ann Surg. 2007 Jan;245(1):88-93

  10. Conclusions • Following preoperative chemoradiation and TME, distal margins of 1 cm seems adequate • Occult tumor beneath the mucosal edge was rare and when present was limited to less that 1 cm • These results extend the indications for sphincter preservation as distal resection margins of only 1 cm may be acceptable for locally advanced rectal cancer treated with preoperative chemoradiation

  11. Study # 2 Distal Margin Analysis Nash G, Paty P, Guillem J, Temple L, Weiser M, and Wong D ( Unpublished Data 2008 )

  12. Distal margin rectal cancer Study Hypotheses • Margin of less than 8mm is associated with higher risk of local recurrence (LR) • Mucosal recurrence (MR) is the mechanism of higher LR

  13. Distal margin rectal cancer Study Cohort 627 patients with primary rectal cancer Study period: 1991-2004 Curative resection No involvement of adjacent organs Low anterior resection Stapled anastomosis Hand-sewn coloanal anastomosis (HSCAA) Median follow up 5.8 years

  14. Distal margin rectal cancer Patient and Tumor Characteristics - LAR

  15. Distal margin rectal cancer Local recurrence DM = 20-60mm DM = 8-19mm DM < 8mm * * P = 0.008 103 95 78 45 23 13 5 230 217 167 99 47 21 9 294 281 220 133 71 35 15

  16. Distal margin rectal cancer Mucosal recurrence DM = 20-60mm DM = 8-19mm DM < 8mm * * P = 0.001 103 97 81 46 25 13 5 230 222 170 99 47 21 9 294 283 222 134 71 35 16

  17. Distal margin rectal cancer Pelvic recurrence (excludes iMR) DM = 20-60mm DM = 8-19mm DM < 8mm P = 0.62 103 95 78 45 23 13 5 230 217 167 99 47 21 9 294 281 220 133 71 35 15

  18. Distal margin rectal cancer Changes over time: 1991-1997 and 1998-2004

  19. Distal margin rectal cancer Variation of LR

  20. Distal margin rectal cancer Variation of LR Use of adjuvant therapy

  21. Distal margin rectal cancer Conclusions Sphincter sparing techniques do not compromise local control or survival Careful surveillance for MR is warranted in patients with close DM Salvage is feasible for most MR

  22. Rationale for ultralow LAR/CAA

  23. Ultralow LAR/CAA with Intersphincteric Dissection • We need less distal margin than we once thought • Internal sphincter is an extension of the rectal wall Weiser et al. Adenocarcinoma of the Colon and Rectum. In Shackelford’s Surgery of the Alimentary Tract6th ed, 2007

  24. Oncologic Outcome of Coloanal Anastomosis *literature review

  25. Study # 3 Sphincter Preservation in low rectal cancer is facilitated by preoperative chemoradiation and intersphincteric dissection Weiser M, Quah HM, Shia J, Guillem J, Paty P, Temple L, Goodman K, Minsky B and Wong D ( Submitted paper 2008 )

  26. Aim of the Study • To evaluate oncologic outcome in patients with locally advanced distal rectal cancer treated with preoperative chemoradiation followed by: • LAR with stapled coloanal anastomosis • LAR with intersphincteric dissection and hand sewn coloanal anastomosis • APR

  27. Background Data • From a cohort of 601 consecutive patients from 1998 – 2004 : • 148 patients were identified with Stage II and III rectal cancers (ERUS Staged uT3-4 and/or N1) at or below 6 cm from the anal verge • All treated with preoperative long course chemoradiation and TME

  28. Median Distal Margin Median Distal Margin • LAR Stapled Coloanal 1.1 cm ( 0.9 – 1.3 cm) • LAR Handsewn Intersphincteric 1.0 cm ( 0.9 – 1.3 cm) • APR 4.0 cm ( 3.5 – 4.6 cm)

  29. Oncologic Outcome (MSKCC data) MSKCC 2008

  30. Oncologic Outcome (MSKCC data) MSKCC 2008

  31. Oncologic Outcome of Coloanal Anastomosis N=149 MSKCC 2008

  32. Conclusions • In low rectal cancer, sphincter preservation is facilitated by significant response to chemoradiation and intersphincteric dissection without oncologic compromise • APR is more likely required in those patients with lesser response to neoadjuvant therapy and is associated with poorer outcome

  33. Functional outcome of ultralow LAR with coloanal anastomosis

  34. Functional Outcome after LAR/CAA • 81 patients • Median 2 BM / day • Continence complete 51% incontinent gas 21% minor leak 23% significant leak 5% • 56% excellent or good composite function (continence, evacuation, #BMs) • 74% of patients were satisfied Paty et al. Long-term functional results of coloanal anastomosis for rectal cancer. Am J Surg. 1994;167:90-95.

  35. QOL: Anal Sphincter Preservation or Sacrifice • Despite LAR patients suffering defecation problems, they had better QOL than APR patient • Bowel function did not significantly impact on overall QOL • Stoma patients • More limited everyday work and hobby activities (role functioning) • More disrupted social and family life (social functioning) • Less able to get about and look after themselves (physical functioning) • Felt less attractive (body image) • These changes persisted over time (4 years) • LAR scores improved with time while APR did not. • Greatest improvement in QOL was when temporary stomas were reversed. Engel et al. Quality of life in Rectal Cancer Patients. Ann Surg 2003;238:203-213.

  36. LAR vs APR Quality of Life:Stoma vs Sphincter Preservation • “Meta-analysis” • Validated instruments • Studies including APR and LAR • Study included data from 11 studies • 1443 patients • 486 patients with APR • All retrospective • Validated instruments • 4 SF-36, 7 EORTC 30, 8 EORTC – CRC38 Cornish et al. Ann Surg Onc, 2007; 14: 2056-2068

  37. QOL: SPS vs APR Overall when comparing APR to LAR, no differences in general QOL were identified Cornish et al. Ann Surg Onc, 2007; 14: 2056-2068

  38. Conclusions • A 1 cm distal margin is acceptable in patients undergoing neoadjuvant tx • Ultra-low LAR/COLOANAL is oncologically sound • Restores body image • Majority of patients are satisfied with their QOL

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