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D igestive D isease C enter Department of Colorectal Surgery Cleveland Clinic

Laparoscopy in Colorectal cancer: Where are we now?. D igestive D isease C enter Department of Colorectal Surgery Cleveland Clinic. Feza H. Remzi MD, FACS, FASCRS. Conclusions. Safe for colon cancer Return of earlier bowel function Less postoperative pain

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D igestive D isease C enter Department of Colorectal Surgery Cleveland Clinic

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  1. Laparoscopy in Colorectal cancer: Where are we now? Digestive Disease CenterDepartment of Colorectal SurgeryCleveland Clinic Feza H. Remzi MD, FACS, FASCRS

  2. Conclusions • Safe for colon cancer • Return of earlier bowel function • Less postoperative pain • Better pulmonary postoperative function • Shorter hospital stay • Smaller incision • Its application in rectal cancer needs to be determined

  3. Conclusions • Selection • Early conversion • Do not compromise for the sake smaller incision • No short cuts and do not change your routine • Patients come first

  4. Issues and Questions • Does the method of access (LAP vs. Open) in the resection of colon CA affect outcome? • Short term recovery • Long term oncologic outcome • Is there enough data say LAP is safe? • What will be the role of laparoscopy in the treatment of colorectal CA in 2007?

  5. Colon

  6. History • First reports of LAP for colon CA in 1990 • Technically difficult and challenging • Time consuming • Short-term benefits (pain, ileus, hospitalization) have not been pronounced compared to open surgery Has led to resistance among surgeons to learn the technique

  7. Port Site Recurrence • Recurrence of tumor in a trocar wound without advanced abdominal disease • First report in 1993 • Initially reported rates: 0 - 21%* • NOT necessarily with advanced cancer • Cast a dark shadow over laparoscopic surgery for malignancy *Berends, Lancet 1994

  8. Port Site RecurrenceProposed Mechanisms • Direct seeding of exfoliated cells at port sites • Aerosolized cancer cells with pneumoperitoneum • CO2 enhances tumor growth* • Local conditions at port sites favor implantation • Poor surgical technique (spillage of tumor cells at operation) Jones et al. Dis Colon Rectum 1995;38:1182-8. Wu JS. Surgery 1997;122:1-7. Jacobi et al. Surgery 1997;121:72-78. Bouvy et al. Annal Surg 1996;224:694-701. Nduka et al. Surg Endosc 1998;12:515. Mathew et al. Br J Surg. 1996;83:1087-1090. Watson et al. Arch Surg. 1997;132:166-168. Neuhaus et al. Surg Endosc 1998;12(5):516. Nduka et al. Surg Endosc 1998;12(5):515. Jacobi et al. Surg Endosc 1998;12(5):513. *

  9. Port Site Recurrence RatesMid 1990’s Study Year Recurrences Operations Percent Ramos 1994 3 208 1.4 Jacquet 1995 7 445 1.6 Lumley 1996 1 103 1.0 Kwok 1996 1 100 1.0 Fleshman 1996 4 372 1.1 Franklin 1996 0 191 0 Vukasin 1996 5 480 1.1 Huscher 1996 0 146 0 Total 21 2045 1.0 % *Series greater than 100 patients Hughes ’83, Reilley ’96 : Incisional recurrence 0.6 – 0.8 % in open surgery

  10. Port Site Recurrence RatesRecent Series

  11. Port Site Recurrence • In experienced hands, the rates of PSR are acceptable • High rates of PSR in earlier reports must have been due to poor surgical technique • Animal models suggesting increased tumor growth with CO2 pneumo did not replicate “real-life” conditions

  12. Background: LAP for Colon CA • Our team started in 1991: • Animals • Cadavers • Limited benign diseases • Indications expanded in 1993: • Malignancies

  13. Background: Feasibility Studies Phase I Studies – Cadavers • 1993 - Rt. Hemicolectomy (Bohm et. al) • 1993 - Proctosigmoidectomy (Milsom et. al) • 1993 - Abdominoperineal Resection (Decanini et. al)

  14. LAP Surgery for Colorectal CAEarly Large Prospective Series • Franklin et al (‘96): 191 LAP / 224 OPEN • At 3 yrs: No disadvantages, no port site mets, faster recovery • COST Group (‘96): 372 pts LAP • No early mets, no port site mets • Poulin et al (‘99): 117 pts LAP • 54% survival in stage III at 48 months *No obvious early disadvantages

  15. Adequacy of ResectionRandomized Colectomy Trials Study LAP vs. Open Nelson* NSD + Milsom ** NSD Lacy*** NSD *N.C.I. / C.O.S.T. Trial, 1996 ** Cleveland Clinic Trial, 1996 *** Barcelona Trial, 1995 + NSD= no significant difference Bowel margins, # of lymph nodes similar

  16. First Randomized Colectomy TrialPreliminary Report • Cleveland Clinic Foundation • n=109 (55 LAP vs. 54 Open) • Median FU: 17 months (range 1.5 –46) • No port site recurrences • Similar number of cancer-related deaths *Milsom, JACS 1998

  17. Cleveland Clinic Trial Short term advantages to LAP • Less narcotic use * • Earlier return of flatus (3.0 vs. 4.0 days) * • Earlier return of FEV1 and FVC to 80% of pre-op (3.0 vs. 6.0 days) * * p < 0.05

  18. The Barcelona Trial • Lacy et al, 1993 – 1998 • Single institution, two surgeons • All non-metastatic colon cancer • n=219 (111 LAP vs. 108 Open) • Intention to treat analysis • Median FU: 43 months (range 27 - 85)

  19. : p < 0.05 * Tumor Recurrence and Mortality LAP Open Tumor recurrence Time to recurrence (mo) Overall mortality Cancer-related mortality * 18 (17%) 15 (14) 19 (18%) 10 (9%) 28 (27%) 17 (12) 27 (26%) 21 (21%) Lacy AM, Lancet2002

  20. COST* Study GroupRandomized Prospective Study • Nelson, et al. • Non-inferiority randomized trial • 48 institutions, USA and Canada • n=872 (1994 – 2001) • Median FU: 4.4 years • Primary endpoint: Time to tumor recurrence *Clinical Outcomes of Surgical Therapy Study Group Nelson, NEJM, May 2004

  21. Inclusion Criteria • > Age 18 • Adenocarcinoma of the colon Exclusion Criteria • Prohibitive abdominal incisions • Advanced or metastatic disease • Transverse colon or rectal cancer • Acute obstruction or perforation • Severe medical illness

  22. Credentialing • 66 surgeons at 48 institutions • > 20 LAP colectomies • Video to review oncologic technique • Random audit of videotapes* • Assessment of bowel margins* * Reviewed by external monitoring committee

  23. Randomization Stratification variables • Tumor site • Right, left, sigmoid • ASA classification • I, II, or III • Surgeon

  24. Survival and RecurrenceCost Trial * True for any stage

  25. Short Term ResultsCost Trial Surgical margins, # of LN’s similar

  26. COST Trial Conclusions • LAP is not oncologically inferior to Open • Marginal short term benefits seen with LAP in post-operative recovery • Similar complications rates (LAP vs. Open) • “… it is safe to proceed with laparoscopically assisted colectomy in patients with cancer.”

  27. Results • COST trial results substantiate results found in other trials • LAP for colon CA is oncologically safe • Small benefits are seen in post-operative recovery with LAP • With good surgical technique, the rate of port site recurrences is minimal

  28. Summary • Whether LAP is oncologically superior to open surgery is still controversial… • In 2007: LAP is here to stay • Patients will demand it.. • Anticipate more and more cases of colon CA will be resected laparoscopically

  29. Cleveland Clinic Trial Longterm Results • It is the only prospectively randomized study with 10 year or more follow -up • There were no differences between the Lap versus open groups stage by stage in cancer specific survival or recurrence Geissler ASCRS Seattle 2006

  30. COLOR Trial • 1997-2003, 29 centers in Europe • Over 600 patients in each group • Less pain, blood loss, earlier recovery of bowel function and shorter hospital stay in Lx group • 17 % conversion rates • Equivalent morbidity and mortality Lancet 2005

  31. CLASICC Trial • 1996-2002, 27 UK centers • 794 patients • Less pain and shorter hospital stay in Lx group • 29 % conversion rates • Equivalent morbidity and mortality • Increase positive radial margins in LX group • Converted patients had raised complication rates Lancet 2005

  32. Summary • Surgeons participating in the COST study were experienced in LAP colectomies • The results of the COST trial is not a license to start LAP colectomies for malignancy • “Proceed with caution…” We owe it to our patients to exercise good oncologic technique and COMMON SENSE to avoid unwanted results!!!

  33. Rectum

  34. Laparoscopic Learning Curve • 461 cases among 3 surgeons • Operative time evaluated • Conclusion: • 30 case learning curve Schlachta – DC&R 2001

  35. Discussion • Biases of self-designated interests • Better technique • Better approach to patients • Better follow-up • Superior psychological support

  36. Surgeon Procedure Volume and Outcome • 2815 rectal cancers • 30 day mortality not influenced by doing more that 21 cases • 2 year mortality was very significantly influenced (34 vs 24% mortality) Schrag-Ann Surg 2002

  37. Surgeon’s Influence • The surgeon is the most significant variable we can influence in the treatment of patients with colorectal cancer • Breast • Cardiac • Pancreas • Esophagus • ? Lung

  38. We must accept the fact that surgical technique is important to outcome and that change in technique cannot be accepted without validation.

  39. CLASICC TrialGuillou Lancet 2005 LAR Radial Margin Positive Open = 4/64 (6%) Laparoscopic = 16/129 (12%) NS Converted = 29% • Increased TME achieved with laparoscopy • Concern raised about the risk of increased local recurrence

  40. Laparoscopic vs Open Surgery for Rectal Cancer: a meta-analysis • 20 studies • 2071 patients; 909 LX, versus 1162 open • Short term outcomes may be improved • Laparoscopic rectal cancer surgery results in an earlier postoperative recovery and a resected specimen that is oncologically comparable to open surgery Aziz 2006 Ann Surg Oncol

  41. Laparoscopic and Open Anterior Resection for Upper and Mid Rectal Cancer • 265 patients • Stage I, II similar 3 yr survival • Open = 89.8% • Lap = 88.6% • Stage III 3 yr survival of concern • Open = 65.6% • Lap = 55.5% Law-DC&R 2006

  42. There is no short term advantage that can outweigh increased long term cancer recurrence

  43. Laparoscopic vs. Open total Mesorectal Excision for Rectal CancerCochrane Database 2006 80 studies identified • 48 met inclusion, 4224 patients • Methodological quality of most of the included studies was poor. • There is evidence that LX TME results in less blood loss, quicker return to normal diet, less pain, less narcotic use and less immune response. It seems likely that LX TME is associated with longer operative time and higher costs. No results of quality of life were reported.

  44. Ethical Issues • Offering experimental ? surgery outside of a research environment • A Marketing tool

  45. Conclusion • Surgical technique is important • New techniques must be validated • Laparoscopic LAR has increased CRM • Laparoscopic proctectomy remains unproven and certainly not the standard

  46. Conclusions • Safe • Return of early bowel function • Less postoperative pain • Better pulmonary postoperative function • Shorter hospital stay • Smaller incision • Its application in rectal cancer needs to be determined

  47. Conclusions • Selection • Early conversion • Do not compromise for the sake smaller incision • No short cuts and do not change your routine • Patients come first

  48. Preoperative Rectal Cancer Staging

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