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Warren E. Enker, M.D., F.A.C.S.

TME as Standardized Surgery in Rectal Cancer. Total Mesorectal Excision: Standardization of Curative Surgery for Rectal Cancer The Prevention of Pelvic Recurrence, Sphincter-Preservation, Preservation of Autonomic Functions, and Cure. Warren E. Enker, M.D., F.A.C.S.

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Warren E. Enker, M.D., F.A.C.S.

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  1. TME as Standardized Surgery in Rectal Cancer Total Mesorectal Excision: Standardization of Curative Surgery for Rectal Cancer The Prevention of Pelvic Recurrence, Sphincter-Preservation, Preservation of Autonomic Functions, and Cure Warren E. Enker, M.D., F.A.C.S. Chief, Colorectal Surgery and Vice Chairman, Department of Surgery Beth Israel Medical Center Director of Surgical Oncology and Associate Director Continuum Cancer Centers of New York

  2. Total Mesorectal Excision in Rectal Cancer Rectal Cancer is a Disease of Major Impact • Cure or Survival • Pelvic Recurrence or Surgical Failure • Utilization of Medical Resources • OR time, RT time, Chemo suite and infusion devices, Stoma appliances, etc. • Function impairment • Organ and function preservation • Body and emotional image • Social and economic issues • Time lost from work • Social withdrawal

  3. Salvage Surgery: Regional Recurrent Colorectal Cancer 48/744 R0 Resection (6.5%) 24/48 Survived NED (3.2%) Bowne, et al. Dis Colon Rectum 2005

  4. Total Mesorectal Excision in Rectal Cancer TME Background:The Clinical Problem • Worldwide, the typical operation for a primary rectal cancer is performed without regard for either the natural history of cancer or for pelvic anatomy. • Blunt, often blind, traumatic dissections ( no defined planes) produce arbitrary or violated specimens that are not standardized from case to case. Frequently the circumferential margins of the peri-rectal fat are involved by cancer or torn, leaving behind residual pelvic cancer. • Permanent colostomy and the needless sacrifice of sexual and urinary functions are common.

  5. Total Mesorectal Excision in Rectal Cancer Conventional Surgery: The Clinical Outcomes • The worldwide results of such conventional surgery (1960’s-1990’s) include: • Local recurrence rates of 30-40% • 5-year survival rates of 35-45% in patients with involved nodes • Disseminated disease affecting 60-65% of node positive patients • Sphincter-preservation in only 45% of patients with cancers from 0-15 cm from the anal verge* • Impotence in 50-85% of male patients • *Evans, et al. JACS 1994

  6. Total Mesorectal Excision in Rectal Cancer TME Background:The Clinical Problem In most other area of the body, e.g., Thoracic, Head and Neck, Upper GI, GU, etc., cancer surgery involves meticulous sharp dissection along known anatomic planes or pathways, to resect a primary tumor, its possible direct extensions, and its region of potential nodal spread with negative or uninvolved surgical margins. The result is an anatomically and pathologically reproducible specimen, with predictable clinical outcomes, and with function and organ preservation where possible.

  7. Total Mesorectal Excision in Rectal Cancer The Clinical Problem: Rectal Cancer is a Regional Disease • Up to 85% of patients present with either full-thickness • penetration of the bowel wall (T3/4) or with involvement • of regional mesorectal lymph nodes i.e., N1-N2 disease. • Operations for rectal cancer should be based upon • the premise that the surgeon will resect the primary tumor • as well as all regional disease (R0) with an intact, unviolated • mesorectum, anduninvolved circumferential resection • margins (CRM-).

  8. Blunt dissection fails to clear the pelvis of mesorectal disease Havenga, et al.

  9. 1. The recto-sacral fascia does not yield to blunt dissection and leads to violation of the Mesorectum. 2. AP Resection Havenga, et al.

  10. Total Mesorectal Excision in Rectal Cancer Outcomes of Blunt Dissection (CRM+) • 52 surgical specimens of “curative operations” studied by transverse whole-mount cross sections. • 14 of the 52 (27%) specimens demonstrated unsuspected involvement of the circumferential margins and violation of the mesorectum, etc. • 12/14 patients (85%) developed local pelvic recurrence. Extended to >500 cases by Adam, et al. • Conclusion: Inadequate circumferential margins of resection are responsible for local recurrence. • Quirke, et al. Lancet, 1986

  11. Total Mesorectal Excision in Rectal Cancer In Many Countries These Surgical Problems Have Been Addressed: • In Norway, the surgery for rectal cancer has been removed from the training programs in General Surgery after a nationwide study of local recurrence rates. (Norstein, et al) • In the Netherlands, the concept of a standardized resection for rectal cancer was introduced by a nationwide clinical trial of TME with or without Radiation Therapy.(Kapiteijn, et al ) • In the United Kingdom, the development of Specialty Services, and workshops including cadaver resections have helped to alter attitudes and NHS referrals. (Heald, et al) BIMC ‘04

  12. Total Mesorectal Excision in Rectal Cancer In the United States, the Surgical Problem Persists Because: 1.Nationwide, the average general surgeon in practice (rural and urban) performs only 6-8 colon cases/year. 2. Many active surgeons have been taught to remove any palpable cancer of the rectum by Abdomino-Perineal Resection with permanent colostomy. 3. After residency, there is little likelihood of altering technique or developing expertise. 4. Fear of malpractice reinforces the practice of conventional, bluntly performed surgery. 5. Limited experience perpetuates conventional outcomes. BIMC ‘04

  13. Total Mesorectal Excision in Rectal Cancer Goals of Surgery for Rectal Cancer • Cure • Prevention of Local Recurrence • Reduction of Treatment-Related Morbidity • 1. Sphincter-preservation wherever possible • 2. Preservation of ano-rectal function • 3. Preservation of sexual and urinary functions Roma ‘03

  14. J. K. Gilchrist 1935

  15. Internal Iliac Lymph Node Distribution in Rectal Cancer Wide Anatomic Resection and Internal Iliac Lymphadenectomy in 52 Patients A meticulous sharp anatomical dissection Coller, Kay, and McIntyre; Annals of Surgery 1941

  16. Middle rectal artery (lateral ligament) and internal iliac lymph node distribution

  17. George E. Block, MD 1925-1993

  18. Total Mesorectal Excision in Rectal Cancer Consequences of Internal Iliac Lymphadenectomy b 1. A low yield of involved lymph nodes. Lateral spread observed in only 6/52 patients (10-15%) with anecdotal benefit. 2. Significant Incidence of both Impotence and Urinary dysfunction due to pelvic autonomic nerve injury. Roma ‘03

  19. John F. Lee, MD Virginia Maurer, MD

  20. Pelvic Autonomic Nervous System Lee, Maurer And Block Arch Surg 1973

  21. Roma ‘03

  22. Parietal Visceral Waldeyer’s dissections of pelvic fasciae

  23. Other Surgical Observations Walsh and Tsuchiya: Described the Autonomic Nerve-preserving Radical Pelvic Operations. Implication: The same plane separating the autonomic nerves from the intact VLPF should also exist within the posterior visceral compartment of the pelvis surrounding the rectum and mesorectum. UChicago ‘03

  24. Parietal Visceral Resection of an Intact Mesorectum

  25. Medial Segment of the Lateral Ligament (Satoh, et al) TME with Pelvic Autonomic Nerve Preservation

  26. Total Mesorectal Excision in Rectal Cancer Definitions of Total Mesorectal Excision (TME) • Heald: Complete excision of the rectum and the mesorectum • Including the most distal portion of the mesorectum down • to the anal hiatus • Enker: Complete excision of the rectum and mesorectum • to a distance of 5 cm of mesorectum distal to the lowest • palpable edge of the primary tumor. An intact VLPF, with • uninvolved circumferential margins (R0, CRM-). • A standardized operation resulting in a reproducible specimen. • Sharp dissection under direct vision between the visceral and the parietal layers of the pelvic fascia, i.e. PANP. Tokyo ‘01

  27. TME for Rectal Cancer Outcomes of TME in 171 “High Risk” Patients * *Absence of stage-related data Exclusion of “Locally Advanced” lesions MacFarlane, Ryall, and Heald, Lancet 1993

  28. Total Mesorectal Excision in Rectal Cancer Current Status of TME: 1979-1998( Rectal Cancers0-12 cm from the Anal Verge) • Current No. of patients (6/2003) 744 • No. of patients through 12/1998* 5441 • Total No. of patients in 1995 467 • “High Risk” patients in 1995 2462 • Median age 61 years (26-93) • Male 319 (59%) Female 225 (41%) * Minimum five year follow-up 1. Murthy, WE, et al Seminars Surg Oncol 2002 2. Enker, WE, et al. J. Amer Coll Surg 1995

  29. Total Mesorectal Excision in Rectal Cancer Current Status of TME: 1979-1998 • Median follow-up 5.2 years • Five year survival(DOD) in 537/544 patients 74.4% • Local recurrence-free survival 94.8% • Local recurrences 23/537 patients Actuarial 5.2% Observed 4.3% Murthy, Seminars Surg Oncol 2002

  30. Total Mesorectal Excision in Rectal Cancer Current Status of TME: 1979-1998 Survival By Stage of Disease ( N=544) STAGE No. Survival %* T1-2N0M0 162 94.6 T3N0M0 114 87.3 TanyN1-2M0 170 66.3 T3N1M0 72 74.4 T3N2M0 42 61.2 T4N0M0 9 87.5 * Compared to SEER data. Murthy, Seminars Surg Oncol 2002

  31. Current Status of TME: 1979-1998 Local Recurrence-Free Survival By Stage of Disease (N=544) STAGE No. Percent (Rate) T1-2N0M0 162 97.6 (2.4%) T3N0M0 114 97.5 (2.5%) TanyN1-2M0 170 89.5 (10.5%)* T3N1M0 72 95.1 (4.9%) T3N2M0 42 89.0 (11%)* T3N1-2M0 115 93.1 (6.9%) *T4 or N2 Disease Murthy, Seminars Surg Oncol 2002

  32. Total Mesorectal Excision in Rectal Cancer Current Status of TME for Rectal Cancers (0-12 cm): 1979-1998 Low Anterior Resection N=378 Primary Lesion to Anal Verge 0-5cm 8 6-10 cm 328 11-12 cm 42 Overall Survival 73.2% Cancer-Free Survival 76.1% Local Recurrence-Free Survival 95.7% Murthy, Seminars Surg Oncol 2002

  33. Current Status of TME: 1979-1998 Low Anterior Resection vs. AP Resection: Percent Five Year Survival (>T3N0) STAGE LAR(378) APR(166) OVERALL 76.1 60.1 p=<.001 T3N0M0 87.9 77.2 T3N1M0 69.6 58.0 T3N2M0 63.1 50.0 T3N1-2M0 67.2 56.9 TanyN1-2M0 66.9 44.0 T4, N2 Disease and < 5 cm Murthy: Sem Surg Oncol 2002

  34. Current Status of TME: 1979-1998 Low Anterior Resection vs. AP Resection Percent Local Recurrence-Free Survival (>T3N0) LAR(378) APR(166) OVERALL 95.7 92.8 n.s. T3N0M0 98.0 96.2 T3N1M0 88.5 77.3 T3N2M0 100 86.3 T3N1-2M0 93.6 92.4 TanyN1-2M0 91.7 85.0 Murthy: Sem Surg Oncol 2002

  35. Dukes A Dukes B Dukes C

  36. TME in Rectal Cancer Proper resection of regional disease influences both dissemination and survival • Conventional Surgery • 60-65% overall recurrence1 • 40-55% metastatic disease1 • TME • 23-35% overall recurrence2 • 15-25% metastatic disease (50% lung)3 • 1. NCCTG 1991 • 2. MacFarlane, Ryall and Heald: Lancet, 1993 • 3. Enker: J Amer Coll Surg, 1995 • Murthy: Sem Surg Oncol, 2002

  37. TME Standardized Operations for rectal Cancer In the light of these results, why are there recurrences? THE Three “E’s” Exposure (Surgical) Education (Peer-to-Peer) Evaluation (Pathological)

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