Konkurrierende Verfahren bei kolorektalem Karzinom: Laparoskopie inklusive TaTME

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1 Konkurrierende Verfahren bei kolorektalem Karzinom: Laparoskopie inklusive TaTME Prof. Dr. Michel Adamina, MSc, EMBA HSG Klinik für Viszeral- und Thoraxchirurgie Kantonsspital Winterthur & University of Basel Switzerland

2 Incidence Colorectal cancer is on the rise second to male and female Shift towards younger age In Switzerland, about new colorectal cancer yearly Prognosis shift: rectum cancer better than colon cancer? Why better (neo)adjuvant ttt? screening? surgery? surgeons? 2

3 Landmarks in rectal cancer surgery Neoadjuvant RCT Miles APR Dixon Anterior resection Heald RJ Mesorectum pelvic recurrence M. Jacobs Laparoscopic TME & APR 3

4 Rationale The interdisciplinary management of rectal cancer is evolving Neodjuvant approaches Watch and Wait New surgical approches Tailored adjuvant therapy Introduction of transanal total mesorectal excision (tatme) Sylla Surg Endosc 2010, Lacy JACS 2015 St.Gallen Consensus on 4

5 Why should minimally invasive surgery be better Intuitively, ask yourself what would you want to have 5

6 Why should minimally invasive surgery be better Evidence Recovery LOS incl. opioid, ileus, back to work, resources Adhesions Surgical side infections - and its consequences 6

7 Patients (%) Gastrointestinal recovery In hospital resources Recovery of BM & tolerance of solid food Hospital discharge Postoperative day Aufwand in Minuten ,28 416, Tag des Aufenthaltes ERP Durchschnitt ERP Konventionell Durchschnitt Konventionell Kehlet Lancet 2003 Delaney AJS 2006 Adamina Surgery 2011; Ann Surg

8 Laparoscopic colorectal surgery Bowel function, resumption of diet, and length of stay 2 days shorter to ~ 5 days Estimated blood loss halved Morbidity largely reduced to 15% ~ 35% postoperative pain and opioids consumption skilled nursing facility utilization quality of life and recovery Kiran RP ArchSurg 2004 Kuhry E Cochrane Database Syst Review 2009 Klarenbeek BR AnnSurg 2009 Delaney CP Ann Surg

9 Beyond short-term outcomes Short-term outcomes clearly in favour of laparoscopy Let s talk about cancer outcomes 9

10 Current treatment of rectal cancer Early rectal cancer (T1,T2,N0) Advanced rectal cancer T3, TxN1 T1sm1 (sm2) good MRI poor Neoadjuvant chemoradiotherapy TAE/TEM TAMIS Radical Surgery TME +/- proctectomy open - laparoscopic robotic - transanal Organ preservation wait & watch protocol 10

11 Laparoscopic TME Laparoscopic TME is the standard of care in skilled hands? CLASSIC, COLOR II, COREAN, ACOSOG, alacart, etc Not totally free of controvery! Meta-analysis of 14 RCT, 4034 patients:.rr of near-complete/incomplete TME 1.31 ( ) Convert timely to avoid bad outcomes Long-term results awaited to assess whether these.pathologic results affect disease-free and overall survival 2-year DFS and OS NOT different (ACOSOG, alacart) Martinez-Perez JAMA Surg 2017 Stevenson AnnSurg 2018 Fleshman AnnSurg

12 Unsolved issues in TME surgery 1. Anatomy: male, obese, narrow pelvis, radiation 2. Sphincter preserving rate poor oncology outcome of APE 3. Distal stapling cross stapling, #reloads, reach, avoid CAA 4. Margins CRM, distal margin visualized 5. Adequate TME really total mesorectal Best possible oncological and functional outcomes Surgeon as a risk factor training & mentoring 12

13 Unsolved issues CRM and conversion rates 13

14 Rationale Transanal total mesorectal resection as an alternative to conventional TME Sylla 2009 for low to mid rectal cancer to achieve clear distal and circumferential margins to improve quality of the mesorectal specimens in particular in the obese / narrow pelvis / bulky tumor COLOR III Surg Endosc

15 Minimally invasive surgery transanal TME Most obvious benefit in male, obese, low resections better visualization, avoids multiple staplers, safer / better? unseen major morbidity, unneeded TME, steep learning tatme registry 115 centres, 34 countries, > 2000 cases RCT in years COLOR III, GRECCAR 11 starting 2017 St.Gallen Consensus on Safe Implementation of transanal TME guidance on patient selection, indication, technique highlighting challenges, benefits, and dangers of tatme Penna Ann Surg 2016 Adamina Surg Endosc

16 Aim of the St.Gallen Consensus on Safe Implementation of tatme TaTME may address the limitations created by the narrow pelvis, a bulky tumor, and a fatty mesorectum However, guidance is required to ensure safe implementation avoid major morbidity encountered by the early adopters Broad international consensus statement 37 surgeons, pathologist, radiologist, oncologist 20 countries, 5 continents 16

17 Methods Invited group of international experts based on clinical and academic achievements in the field of tatme Delphi methodology 2 first rounds: web based, anonymous Third round: dedicated expert meeting during the European Colorectal Congress held in St Gallen on November 30 th 2016 with face to face open discussion & finalisation of the consensus Consensus was defined as agreement by 80% of the experts 80 statements generated 17

18 St.Gallen Colorectal Consensus Expert Group Michel Adamina Felix Aigner Matthew Albert Stephen Bell Willem Bemelman Luigi Boni Carl J. Brown Gina Brown Nicolas C. Buchs Felix Grieder Ulrich Güller Roel Hompes André d'hoore Cristiano Huscher Masaaki Ito Werner Kneist Joep Knol Antonio Lacy Justin Maykel Arend Merrie Jae Hwan Oh Yves Panis Marta Penna Rodrigo O. Perez Frank Pfeffer Philip Quirke Philippe Rouanet Eric Rullier Gerald Seitinger Colin Sietses Antonino Spinelli A. R.L. Stevenson Patricia Sylla Paris Tekkis Jean-Jacques Tuech Jurriaan Tuynman J. Warusavitarne Mark Whiteford Des Winter Albert Wolthuis. 18

19 Results Participation of the first 2 web-based Delphi rounds was 100% 30/37 (81.1%) colorectal surgeons attended the third round live Remaining 7 televoted achieving 100% participation Agreement on 1. Patient selection and surgical indications 2. Peri-operative management 3. Patient positioning and operative room set-up 4. Devices and instruments 5. Pelvic anatomy revisited: the transanal perspective 6. Learning tatme 7. Outcomes analysis 19

20 Patient selection and indications Especially for difficult cases (male, obesity, BMI) For low rectal cancer Can be used for APE or ELAPE, if enough experience Can be used for IBD (proctectomy) Can be used for redo surgery (advancement procedure) 20

21 Perioperative management Should follow enhanced recovery pathways Mechanical bowel preparation Pelvic drain according to surgeon s preference Urinary catheter to be removed at POD1 Perioperative antibiotic prophylaxis 21

22 Position and set-up Lithotomy position Rectal washout Two-team approach is favoured, whenever possible 22

23 Devices and instruments 30 degree scope (3D if available) GelPoint path access (Applied medical), but exists alternatives Lone star anal retractor (CooperSurgical) Airseal system (Conmed) Monopolar cautery Wound protector 23

24 Pelvis anatomy Novel anatomy the world up side down CAVE Too anterior: vagina and prostate, urethra Too lateral dissection: ureters and pelvic side wall) Too posterior: presacral fascia and veins 24

25 Learning tatme / technique Participation to dedicated courses (hands-on, cadavers) Case observation & hospital visit (one complete theatre team) Proctoring (1-5 cases) Annual centre volume: 10 cases Learning curse >20 cases Standardized technique: step by step approach, ileostomy Hand-sewn coloanal or purse-string colorectal anastomosis Transanal or mini-pfannenstiel extraction 25

26 Structured training pathway advised 26

27 Prospective outcome monitoring Oncologic outcomes & function - Pathology report - Survival International benchmarking Quality of life EORTC QLQ-C30 & EQ-5D - Urologic function ICSmaleSF - Sexual function IIEF-5, FSFI-6 - Bowel function LARS 27

28 tatme the technique 28

29 Operation room setup 29

30 Transanal instrumentarium 30

31 tatme 2-team approach: starting the case Laparoscopy - Standard 4 port - Sigmoid occlusion Transanal - Insertion of the platform - Marking of distal resection - Purse string (Prolene 2-0) 31

32 tatme 2-team approach: key steps Laparoscopy - Exclude carcinomatosis - Rectosigmoid mobilisation - Preservation of hypogastric nerves and left ureter - Oncologic control of mesenteric vessels - Take down splenic flexure Transanal - Circular full thickness rectotomy - Posterior, then anterior dissection presacral venous plexus membranous uretra, nerves - Lateral dissection nerves and «big» vessels - Colorectal anastomosis 32

33 Study the MRI and plan dissection 33

34 Tricks for transanal mesorectal excision Halo effect leads to tempting, yet bad planes tatme: dissection tips using «O»`s and «triangles» Bernardi & Hompes Tech Coloproctol (2016) 34

35 Mid rectal cancer mrt3c N2 CRM 10mm 9cm from AV mr T3c N2 Clear margins Neoadj RChT 35

36 Platform insertion - pneumorectum 36

37 Transanal purse string Transanal - Rectal washout Betadine - Insertion of the platform - Marking of distal resection - Pursestring (Prolene 2-0) avoids pneumocolon minimizes spillage 37

38 Mid rectal cancer mrt3c N2 CRM 10mm 38

39 Mid rectal cancer mrt3c N2 CRM EEA mm long pin Mercury grade 1, Quirke grade 3, CRM 4mm, distal margin 2cm TRG 2, ypt3 ypn1b (2/24) L0 V0 Pn0 R0 39

40 Own data - Demographics 97 patients operated on between Jan 2015 and December 2018 N / Median Interquartile range (IQR) / total range / % Male : Female 71 : 26 71% : 29% BMI Age Tumor Location (cm, anal verge) Neoadjuvant Chemoradiation , % Routine Ileostomy % 40

41 Own data - Results N / Median IQR Surgery Time (min) Conversion to lap. TME 1 1.3% 1 Team (n=39) 406 * Team (n=58) 326 * CRM (mm) no CRM Lymph nodes (35 N+) T stage M stage (liver/lung) 5 - Quirke 3 - Mercury 1 89 (92%) - * saves 80 min. / 20% OR time (p=0.009) 41

42 Own data - Results 90-day complications N % Anastomotic leak 10 10,3 - endosponge : reoperation 7 : 3 8 : 3 Superficial wound infection 3 5 Urinary retention 6 10 Dindo-Clavien Classification Grade I Grade II Grade III Grade IV Grade V (exitus) Hospital length of stay (d) 10 IQR day readmission rate 9 9,3 42

43 Benefits Similis et al. Colorect Dis 2016 Penna et al. Ann Surg studies reporting 510 patients Age: years, BMI k Distance to the anal verge 4 to 9.7 cm. OR time min, EBL ml Morbidity rate 35%, mortality 0.2% Leak rate 6.1%, reoperation 3.7% Mean LOS days. Quirke 3: 88% cases, Q2: 6%, Q1: 6%. CRM neg. 95%, distal m neg. 99.7% 720 patients, 634 with rectal cancer 67% males, mean BMI 26.5 kg/m2 Conversion 6% OR time 277 min Morbidity 32.6% 0.5% Leak rate 6.7% Mean LOS 8 days Quirke 3: 85%, Q2: 11%, Q1: 4% R1: 2.7%. 43

44 Risk factors for poor pathology multivariate analysis of registry Rate (%) Adjusted Odds Ratio Tumor distance from anorectal junction > 2 cm % CI P < 2 cm Positive CRM on MRI > 1 mm 4.4 < 1 mm Depth pelvic dissection from abdominal approach > 4cm 3.1 < 4 cm Penna et al. Ann Surg 2016, n=634 44

45 tatme registry anastomoses, for rectal cancer Median anastomosis height: 3 +/- 2 cm, 66% stapled Overall anastomotic failure rate: 15.7% early leak: 7.8%, late leak: 2%, pelvic abscess/fistula: 6.4% anastomotic stricture: 3.6% Failure risk factor in mutivariate analysis male, BMI > 30, diabetes, tumor > 2.5cm, manual anastomosis, EBL > 500ml, ta OR time > 1.5 h Median LOS: 8 days (range 2-94 days) 30-day morbidity: 35.4% - mortality: 2.8% 45

46 Benefits & pitfalls: tatme complications Pitfalls encountered so far Going too deep: presacral fascia Going too lateral (pelvic side wall): bleeding & nerve lesions Going too boldly (antero-lateral): iliac vein Going too big (stapler): rectal lesion distal to the anastomosis Pitfalls heard of Membranous uretra: registry 1.9% (5/720) Vaginal effraction up to rectovaginal fistula CO2 embolism 46

47 Rationale, indications, and benefits of tatme Low to mid rectal cancer refrain from unneeded total mesorectal excision high rectal cancer best by laparoscopic TME No gender, BMI, or tumor size / height limitation start own series with easier cases (e.g. non irradiated, slim female) Appropriate training & mentoring required and adviseable Prospective outcomes monitoring, incl. function participation to RCT: COLOR III, GRECCAR 11 47

48 tatme in 2019 in our view Pro - Customized resection height - Superior visualization - No cross staple fighting - Single stapling - 2 teams speed up OR time - In obese male with low lying cancer intuitively superior Con - Time & resource intensive - Learning curve & case volume - Specific, major complications - Unproven oncologic superiority - Unproven functional results - When feeling unsafe, do convert to lap/open TME! 48

49 Thank you 49