Bridging Techniques. What s between EMR and Traditional Surgery? Elisabeth C. McLemore, MD, FACS, FASCRS

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1 Bridging Techniques What s between EMR and Traditional Surgery? Elisabeth C. McLemore, MD, FACS, FASCRS Associate Professor of Surgery Assistant Program Director, General Surgery Residency

2 Disclosures Applied Medical Ethicon Endo-Surgery Intuitive Surgical Novadaq Cubist Covidien

3 Evolution in Management of Rectal Polypoid Lesions TES TEM, TEO, TAMIS Open MIS Endoscopyassisted Laparoscopy Laparoscopyassisted Endoscopy Transanal Excision Endoscopic (EMR/ESD)

4 Endoluminal Management of Rectal Polypoid Lesions TEM, TEO, TAMIS Endoscopic Transanal Excision Transanal Endoscopic Surgery Mucosal Resection Submucosal Resection

5 Bridging Techniques ESD for Colorectal Neoplasia. 1) Can we do it? 2) Should we do it?

6 Rectal Adenoma Learning from the Evolution of Local Excision for Rectal Neoplasia No Way! Way!

7 This image cannot currently be displayed. TEM: Historical Perspective Instrumentation developed 1980 s Dr. Gerhard Buess University of Tubingen Germany Richard Wolf One of the first complex endoscopic surgical procedures Widespread usage in Europe

8 2000 Rebirth of Enthusiasm for TEM in US Shockingly Increased local recurrence rates following transanal resection of favorable, early rectal cancers Increased advanced laparoscopic surgical training NOTES Portal

9 Advantages of TEM: Improved Visualization Trans-anal Excision TEM

10 VARIETY OF TA ACCESS DEVICES 10

11 TEM vs. Trans Anal Excision Reduced Local Recurrence Rate after Resection Rectal Adenomas TAE 4 30% TEM 3 16% 1 st MIS Procedure in CRS that demonstrated improved, immediate surgical outcomes compared to traditional technique Mahmoud DCR 2001, Moore DCR 2007, Guerriere Surg Endo 2009, Cataldo DCR 2009

12 TEM Technically Superior to TAE TEM Technique: More likely to result in the removal of an Intact, Non-Fragmented Specimen with Clear Resection Margins Lower Recurrence Rates Following Resection TEM TAE Mahmoud DCR 2001, Moore DCR 2007, Guerriere Surg Endo 2009, Cataldo DCR 2009

13 TEM for Adenomas: Overall Recurrence Rates Barendse et al, Endoscopy, 2011;23:941 Pooled analysis of 38 TEM series with recurrence data for pts with rectal adenomas ( ) weighed mean polyp size 37 mm (3 182) pooled estimate of early adenomas recurrence (within 3 months): 5.4% (4 7.3%) late adenoma recurrence 3% ( %)

14 Rectal Cancer Local Excision??? Are You Mental? Shaw! As If!

15 Minimally Invasive Surgical Approaches for Rectal Cancer Radical Resection - Laparoscopic TME - Robotic TME - Transanal TME Local Endoluminal Resection - Transanal Excision (TAE) - Endoscopic: EMR / ESD - Transanal Endoscopic Surgery (TES) TEM: Transanal Endoscopic Microsurgery TEO: Transanal Endoscopic Operation TAMIS: Transanal Minimally Invasive Surgery

16 Minimally Invasive Radical Proctectomy Low Anterior Resection Open Incision Laparoscopic Incisions Robotic Incisions

17 Total Mesorectal Excision (TME) Department of Surgery Confidential Peer Review

18 Radical Surgery for Rectal Cancer Mortality: 2-8% Morbidity 30-50% (increased with preoperative radiation) Urinary dysfunction 5-12% Sexual dysfunction 10-35% Fecal incontinence 20-30% Temporary ileostomy Wound complications SIL LAR LAR Robotic LAR Tough sell for a T1

19 Rectal Cancer Local Endoluminal Excision

20 TEM vs. Trans Anal Excision Local Recurrence Rate after Resection Early Rectal Cancer TAE 0 32% TEM 5 15% Mahmoud DCR 2001, Moore DCR 2007, Guerriere Surg Endo 2009, Cataldo DCR 2009

21 Rectal Cancer: Local Excision is NOT a TME LN Harvest Rate of associated LN metastasis 6-12% 7-22% 30-66% Survival rate 40-55% 22-30% 5%

22 Local Excision Inferior to Standard Resection for T1/T2 Rectal Cancer Moore et al. Surg Clin N Am 2002;82: T1 LR 5 18%, OS 72 87% T2 LR 28 67%, OS 33 75% You, et al. Ann Surg 2007; 245: (National Cancer Database) 5-year LR rate 12.5% vs. 6.9% (LE vs. SR)

23 TEM for Select T1 Rectal Cancer Only one RCT comparing outcome of TEM to AR in pts with T1 rectal lesions Tumor characteristics favoring local tx Mobile 50 pts with T1 lesions randomized to TEM 4 cm (24) in diameter or AR (26) (excluded lesions poorly differentiated, with lymphovascular Well to moderately invasion differentiated and positive resection margins) No vascular/lymphatic invasion < Sm3 level at 40 months, 5-yr survival rate (96%) and local recurrence rate (4.2%) similar in both groups TEM associated with significantly lower LOS, OR time, EBL, analgesic use, complication rates Winde, Dis Colon Rectum 1996;39:969-76

24 Bridging Techniques ESD for Colorectal Neoplasia. 1) Can we do it? 2) Should we do it?

25 Endocrab Video 25

26 Depth of Invasion Matters Haggitt Level Kikuchi Level sm1 sm2 sm3

27 Depth of Invasion Matters 1 Haggitt Level Risk of Lymph Node Mets Level 1 3: 0/44 cases (0%) Level 4: 4/13 cases (31%) +/- Difficult to Use In Practice - Specimen fragmentation - Suboptimal tissue orientation - Ex: 6/24 Haggitt level 3 Lesions with LN+ disease Haggitt et al Gastroenterology 1985

28 Depth of Invasion Matters Risk of Lymph Node Mets sm1: 2% sm2: 8% sm3: 23% Lower Rectum Increased LN+ Kikuchi Level sm1 +/- Difficult to Use In Practice - Specimen fragmentation - Suboptimal tissue orientation Nascimbeni et al DCR 2002 Mayo Clinic Rochester: n~350 sm2 sm3

29 Depth & Width of Invasion Matters Risk of Lymph Node Mets Depth < 2,000 um: 4% Depth > 2,000 um: 17% Width < 4,000 um: 3% Width > 4,000 um: 18% Ueno et al 2004 Japan, Gastroenterology

30 Intact Specimen & Margins Matter TEM Technique: More likely to result in the removal of an Intact, Non-Fragmented Specimen with Clear Resection Margins Lower Recurrence Rates Following Resection Mahmoud DCR 2001, Moore DCR 2007, Guerriere Surg Endo 2009, Cataldo DCR 2009

31 Pathology Matters Incomplete excision, indication of increased risk of residual disease (A) Lymphovascular invasion (B) Poor grade of histological differentiation (C)Tumor budding (D) Cribiform Pattern Ueno et al 2004 Japan, Gastroenterology

32 Bridging Techniques ESD for Colorectal Neoplasia. Can / Should we do it? Yes, but select patients wisely. Improved technology needed for widespread adoption.

33 The ESD Dream Team 1. Skilled Endoscopist 2. Pathologist who believes and can perform sm evaluation and high risk evaluation 3. Physician for Surveillance Coordination

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