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John H Marks MD Chief Section of Colon and Rectal Surgery Main Line Health System Minimally Invasive Surgery for Rectal Cancer Long Term Results.

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Presentation on theme: "John H Marks MD Chief Section of Colon and Rectal Surgery Main Line Health System Minimally Invasive Surgery for Rectal Cancer Long Term Results."— Presentation transcript:

1 John H Marks MD Chief Section of Colon and Rectal Surgery Main Line Health System Minimally Invasive Surgery for Rectal Cancer Long Term Results

2 Speakers Disclosures Covideon-educational grant support, consultant, speakers bureau Wolfe- consultant, speakers bureau Stryker- consultant, speakers bureau Glaxo Smith Kline-consultant Zassi- consultant, honoraria Surgiquest- Scientific Advisory Board Adolor- speakers bureau

3 Section of Colon and Rectal Surgery Main Line Health System Lankenau Hospital and Lankenau Institute For Medical Research Wynnewood, PA

4 The Learning Curve- Laparoscopic Colorectal Surgery

5 Morris Franklin MD-  Franklin ME Jr. LAPAROSCOPIC COLON RESECTION (LETTER). Surgical Laparoscopy, Endoscopy &Percutaneous Techniques. 1992; 2(2):183  Phillips EH, Franklin ME, Carrol BJ, Fallas MJ, Ramos R, Rosenthal D: LAPAROSCOPIC COLECTOMY. Annals of Surgery Dec 216(6):

6 Advocates for Open Colon Surgery

7 Rectal Cancer TME Surgery?

8

9 Can we do Lap TME?

10 Top Questions Rectal Cancer Therapy Radiation Chemotherapy Surgery r Not Needed? Preop? Post-op? Selective? High Dose? Short Course Radiation? Bolus? Agents? TME Laparoscopy????

11 TME TME

12 Laparoscopic Rectal Cancer Med-Line Review articles 2.3 randomized controlled trials (individual) N=17 vs. 17 (Leung 2000) N=203 vs. 200 (Leung 2004) N=82 vs. 89 (Zhou 2004) 3.1 meta-analysis 4.1 Cochrane analysis CLASICC Trial- waiting

13 Laparoscopic Rectal Cancer Med-Line Review articles (10 Review articles: 20%) articles 7 original series 4 review articles (36%) CLASICC Trial- waiting No New Prospective Studies

14 Laparoscopic Rectal Cancer 0 Level 1A Evidence =

15 Laparoscopic Rectal Cancer Will we ever have Level I A evidence? Is it needed? How address hierarchy of questions for rectal cancer?

16 Lap Rectal Cancer Studies AuthorResectionYearDesignLapOpen Mean F/U (mo) TsangLAR2006PNR KimLAR/APR2006PNR MorinoLAR/APR2005PNR /49.7 BarlehnerLAR/APR2005PNR DulcucqLAR2005PNR CLASICCLAR/APR2005PR /3 BretagnolLAR2005PNR LeungLAR2004PR /49.2 ZhouLAR2004PR BreukinkLAR/APR2005PNR25 -- WuLAR/APR2003PNR18 -- LeroyLAR2003PNR MorinoLAR2003PNR ZhouLAR2002PR82--

17 APR RATES Guillou PJ et al. Lancet 2005;365: MRC CLASICC Trial OpenLaparoscopic 27%25%

18 Conversion Rates Guillou PJ et al. Lancet 2005;365: MRC CLASICC Trial Laparoscopic Conversion Rate Overall 34% Year 1-38% Year 6-16%

19 R-0 Resection Rates Guillou PJ et al. Lancet 2005;365: MRC CLASICC Trial Positive Circumferential Margins Open-14% Laparoscopic-16%

20 Laparoscopic vs. Open Total Mesorectal Excision for Rectal Cancer (Cochrane Review) Breukink S, Pierie J, Wiggers T; The Cochrane Collaboration 2007

21 Type of Studies 1.Grade 1b (individual randomised trial) – 3 2.Grade 2b (individual cohort study) – 12 3.Grade 3b (individual case-control study) – 5 4.Grade 4 (case-series) – 28 Breukink S, Pierie J, Wiggers T; The Cochrane Collaboration 2007

22 Mortality Level 1b evidence (3 studies) –Mortality 0-2% –No difference between lap vs. open Level 2b evidence (13 studies) –Mortality 0-2.5% Level 3b evidence (2 studies) –Mortality 0% in both groups Level 4 evidence (19 studies) –Mortality 0-25%; 25% due to one study with only 4 patients of whom 1 patient died Breukink S, Pierie J, Wiggers T; 2007; The Cochrane Collaboration No Difference

23 Morbidity level 1b evidence (3 studies) –6.1% to 29% for the lap group and 12.4% to 35% for the open group –1 study found significant difference between lap and open group (6.1% vs. 12.4%; p=0.016) Level 2b evidence (9 studies) –20% to 37.6% morbidity –1 study did not find any significant difference between the two groups (p=0.26) Level 3b evidence (1 study) –No significant difference between lap vs. open (p=0.26) Level 4 evidence (3 studies) –2 of the studies found significantly less morbidity in the lap group and 1 did not find a difference Breukink S, Pierie J, Wiggers T; 2007; The Cochrane Collaboration No Difference

24 Blood Loss Level 1b evidence (3 studies) –2 of the studies found significantly less blood loss in the open group compared to the lap group Level 2b evidence (3 studies) –56 to 436 ml blood loss in the lap group Level 3b evidence (1 study) –Found less blood in lap group compared to open group (250 vs. 1000ml; p<0.001) Level 4 evidence (3 studies) –2 of the studies found significantly less blood loss in the lap group Breukink S, Pierie J, Wiggers T; The Cochrane Collaboration 2007 Less in Laparoscopy No Transfusion Difference

25 Pathology 1.Distal Margins 2.R-0 Resections 3.Lymph Nodes Lap group = Open group Breukink S, Pierie J, Wiggers T; The Cochrane Collaboration 2007

26 3-Year and 5-Year Disease-Free Survival Rates level 1b evidence (1 study) –5-year disease-free survival rate of 75.3% in the lap group and 78.3% in the open group level 2b evidence (5 studies) –3 studies reported 67-88% survival rate of 5 years in lap –2 studies reported 63-75% survival rate of 5 years in lap level 3b evidence (1 study) –92% survival rate of 3 years in both lap and open group level 4 evidence (2 studies) – % survival rate of 5 years in lap Breukink S, Pierie J, Wiggers T; The Cochrane Collaboration 2007 No Difference

27 Local Recurrence level 1b evidence (1 study) –6.6% local recurrence rate in the lap group and 4.1% in the open group with a follow-up of 52.7 vs months level 2b evidence (8 studies) –3.75% to 6.8% local recurrence reported between 16 and 45.7 months level 3b evidence (4 studies) –0% to 6% local recurrence; no significant difference level 4 evidence (17 studies) –0% to 24.1% local recurrence –5 studies compared recurrence rate between the two groups and found no significant difference Breukink S, Pierie J, Wiggers T; The Cochrane Collaboration 2007 No Difference

28 Postoperative Course 1.The postoperative period of laparoscopic surgery offers the most benefits compared to open surgery 2.There is evidence that laparoscopy results in an earlier return of normal diet, less pain, less narcotic use, and shorter hospital stay

29 Conclusion 1.No immediate differences in oncological outcomes 2.Less blood loss with laparoscopy 3.Clinically measurable short-term advantages in lap group vs. open group Breukink S, Pierie J, Wiggers T; The Cochrane Collaboration 2007

30 Long-term outcomes of patients undergoing curative laparoscopic surgery for mid and low rectal cancer Dis Colon Rectum Jul;52(7): N=185 total Lap Rectal N=103 mid to low cancers Hand-assisted lap surg 58 (56.3%) Lap surg 45 (43.7%) Milsom JWMilsom JW, de Oliveira O Jr, Trencheva KI, Pandey S, Lee SW, Sonoda Tde Oliveira O JrTrencheva KIPandey SLee SWSonoda T

31 Results Mean follow-up time 42.1 months Conversion rate was 2.9% R0 resection rate= 100% The anastomotic leak rate was 7.8% (n = 8). No 30-day mortality LR= 5% at five years. Overall survival was 91% Disease-free survival was 73.1% Milsom JWMilsom JW, de Oliveira O Jr, Trencheva KI, Pandey S, Lee SW, Sonoda Tde Oliveira O JrTrencheva KIPandey SLee SWSonoda T

32 CONCLUSION: Laparoscopic surgical techniques for mid and low rectal cancer seem safe and feasible with acceptable oncologic and long-term outcomes. Further studies, comparing laparoscopic and open methods, are warranted. Milsom JWMilsom JW, de Oliveira O Jr, Trencheva KI, Pandey S, Lee SW, Sonoda Tde Oliveira O JrTrencheva KIPandey SLee SWSonoda T

33 Laparoscopic versus open surgery for rectal cancer: long-term oncologic results Ann Surg Jul;250(1):54-61 Assess long-term oncologic outcome after laparoscopic versus open surgery for rectal cancer and to evaluate the impact of conversion Two Periods of time: – = OpenN= 233 – = LapN= 238 Laurent CLaurent C, Leblanc F, Wütrich P, Scheffler M, Rullier ELeblanc FWütrich PScheffler MRullier E

34 Results: LapOpenPvalue Mortality 0.8% 2.6%; 0.17 Morbidity 22.7% 20.2%; 0.51 R0 Resection92.0% 94.8% 0.22 Laurent CLaurent C, Leblanc F, Wütrich P, Scheffler M, Rullier ELeblanc FWütrich PScheffler MRullier E

35 Results: LapOpenPvalue At 5 years: Local recurrence 3.9% 5.5%0.371 Cancer-free survival 82% 79%0.52 Conversion=15% no negative impact mortality, local recurrence, and survival Laurent CLaurent C, Leblanc F, Wütrich P, Scheffler M, Rullier ELeblanc FWütrich PScheffler MRullier E

36 CONCLUSIONS The efficacy of laparoscopic surgery in a team specialized in rectal excision for cancer (open and laparoscopic surgery) is suggested with similar long-term local control and cancer-free survival than open surgery Moreover, conversion had no negative impact on survival. Laurent CLaurent C, Leblanc F, Wütrich P, Scheffler M, Rullier ELeblanc FWütrich PScheffler MRullier E

37 Laparoscopic TATA Transanal-Abdominal-Transanal Radical Proctosigmoidectomy with Coloanal Anastomosis Transanal-Abdominal-Transanal Radical Proctosigmoidectomy with Coloanal Anastomosis after Chemoradiation Therapy For Rectal Cancer Distal 3cm John Marks, Gerald Marks, Ben Mizrahi Section of Colorectal Surgery The Lankenau Hospital and Institute for Medical Research Wynnewood, PA

38 Goals Rectal Cancer Management Reduce local recurrence Increase survival Maintain normal function – Avoiding a permanent colostomy

39 Materials & Methods Prospective rectal cancer database since 1976 Prospective laparoscopic database since 1996 (N=1089) 102 patients treated with laparoscopic TATA All TME Inclusion criteria: – Curative surgery – Mobile tumors in the distal 3cm following neoadjuvant therapy 79 patients for study Methods

40 Pretreatment Tumor Characteristics Level in rectum from anorectal ring: < 3.0 cm = 100% Mean = 1.2cm( cm) <1cm: 30% Methods N=79

41 Laparoscopic TME Completion Rate Conversion to Open = 2.5% N=2 N=79 Results Surg Endo: Accepted for Publication

42 Morbidity and Mortality No Mortalities Minor Morbidities 18.9% Major Morbidities 11% Immediate: – 2 failed anastomosis requiring stoma Delayed – 4 full-thickness rectal prolapse with repair – 1 ischemic neorectum with successful reanastomosis – 2 bowel obstructions N=79 Results

43 Operative Data Mean EBL: 367cc Positive distal margin: N=1 (1.2%) BMI: 26.5 ( ) # of Trocars: 3: 9 (11%) 4:47 (60%) 5: 19 (24%) 6: 2 (3%) Results N=79

44 TATA: Transanal Portion

45

46

47 Stoma Rate Lifetime normal sphincter function: 90% Neorectal loss due to: – 2 + margins – 2 failed anastomosis – 2 were not reversed due to comorbidities – 1 stoma secondary to bowel obstruction – 1 recurrence Results *All had temporary diverting ostomy following TATA N=79

48 Oncologic Outcomes Local Recurrence: 2.5% KM5YAS: 97% Distant Metastasis: 10.1% N=79 Results Surg Endo: Accepted for Publication

49 Comparison of outcome of open and laparoscopic resection for stage II and stage III rectal cancer Ann Surg Oncol Jun;16(6): Epub 2009 Mar 17 Law WL, Poon JT, Fan JK, Lo SH. Department of Surgery, University of Hong Kong Medical Centre Law WLPoon JTFan JKLo SH Compare survival of patients laparoscopic and open resection for stage II and III rectal cancer Open resection: n = 310 Laparoscopic resection: n = 111 June 2000 to December 2006

50 Results: No Diferrence: –Age, gender, medical morbidities, ASA class, type of operation, morbidity, mortality, pathologic staging Lap Better: –Blood loss, length of stay Law WLLaw WL, Poon JT, Fan JK, Lo SH. Department of Surgery, University of Hong Kong Medical CentrePoon JTFan JKLo SH

51 Cancer Results: Median follow-up = 34 months No difference in local recurrence rates 5-year actuarial survivals were: 71.1% in the laparoscopic 59.3% open groups (P =.029) Law WLLaw WL, Poon JT, Fan JK, Lo SH. Department of Surgery, University of Hong Kong Medical CentrePoon JTFan JKLo SH

52 Cancer Results: Multivariate analysis : Better survival: laparoscopic resection (P =.03, hazards ratio: 0.558, 95% confidence interval: ). Poor prognostic factors: 1.Lymph node metastasis 2.poor differentiation 3.perineural invasion 4.postop complications 5.no chemotherapy Law WLLaw WL, Poon JT, Fan JK, Lo SH. Department of Surgery, University of Hong Kong Medical CentrePoon JTFan JKLo SH

53 CONCLUSIONS: Laparoscopic resection for locally advanced rectal cancer is associated with more favorable overall survival when compared with open resection Law WLLaw WL, Poon JT, Fan JK, Lo SH. Department of Surgery, University of Hong Kong Medical CentrePoon JTFan JKLo SH

54 Future Prospective trials and long-term follow-up are needed COLOR II Randomized Clinical Trial Comparing Laparoscopic and Open Surgery For Rectal Cancer

55 Future Prospective trials and long-term follow-up are needed

56 ACOSOG Z6051- Lap vs Open Rectal Resection

57 Accrual Goal= 480 –240 each arm Endpoints: –Circumferential margins > 1mm –Distal margin > 2cm,> 1 cm distal rectum –Complete TME

58 “If there is no struggle, there is no progress!” Frederick Douglas ( )

59 Airplane Problem or Pilot Problem???

60 Conclusions: ACOSOG trial will put this question to rest Technically can certainly be done No reports show anything worse laparoscopically Better short term outcomes: –Pain –EBL


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