Innovative Surgical Management in the Treatment of Rectal Cancer: MIS, Robotic, and Beyond

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1 Innovative Surgical Management in the Treatment of Rectal Cancer: MIS, Robotic, and Beyond Jonathan E. Efron, MD, FACS, FASCRS The Mark M Ravitch, MD Endowed Professorship in Surgery Chief of the Ravitch Division Associate Professor of Surgery Johns Hopkins University

2 Disclosures None

3 Overview Current Standard of Care Staging Neoadjuvant Therapy Technique MIS techniques TEM/TAMMIS Robotic Approach Watch and Wait

4 Staging Determine extent of local disease History and physical exam pain Digital rectal examination Vaginal examination Endoscopy Imaging Studies

5 Imaging of Body CT Abdomen/Pelvis/Chest CXR MRI US? PET scan

6 Current Neoadjuvant Recommendations in United States T3, NO or any T, N1 or 2 Middle or Distal Rectum Circumferential Margin Long Course Therapy Surgery 8-10 weeks Possibly 12 weeks

7 TME Radial Margin

8 TME Anatomy

9 Total Mesorectal Excision (TME)

10 TME: Heald s Data Outcome 5 year 10 year All Patients(519) Cancer Specific Survival 68% 66% Local Recurrence 6% 8% Curative Only(405) Local Recurrence 3% 4% Disease Free Survival 80% 78% (Heald et al, Arch Surg 1998)

11 Open TME Series: Local Recurrence Author # series # patients Local recurrence rates Wibe et al (NCR*) N/A %LAR; 8.2% APR Ridgeway/Darzi % Colquoun et al. 7 5%-9% * Norwegian Cancer Registry (Gordon and Nivatvongs. Principles and Practice of Surgery for the Colon, Rectum, and Anus 3 rd ed. 2007: 695.)

12 Definitions: MIS Surgery Laparoscopic assisted proctectomy with TME Laparoscopic colonic mobilization with open proctectomy Laparoscopic colonic and rectal resection with laparoscopic TME and double stapled coloanal Laparoscopic colonic and rectal resection with TME and intersphincteric dissection and hand sewn coloanal anastamosis. Laparoscopic Abdominoperineal resection SILS Robotic Hand assisted proctectomy with TME

13 Measures of Quality and Outcome Short Term Complications Mortality Morbidity Pathological Assessment TME specimen, circumferential margins Lymph nodes Long Term Complications Recurrence Survival

14 Laparoscopic Colon Cancer Prospective Trials Group Technique Convert Morbidity Mortality Rec Year n % % % % Lacey Lap (2002) Open COST Lap <1 16 (2004) Open COLOR Lap N/A (2005) Open N/A CLASSIC Lap N/A (2005) Open N/A

15 S/P Resection

16 MIS Surgery for Rectal Cancer Is MIS Total Mesorectal Excision possible? How does the physiology of pnuemoperitoneum and laparoscopic surgery effect the tumor biology? It Doesn t

17 CLASSIC TRIAL: Rectal Data Variable Open Laparoscopic Intention to treat Actual treatment Conversion rate N/A 82 (57%) Complications 18 (14%) 45 (18%) + CRM* for AR** 14 (14%) 30 (16%) + CRM* for APR 7 (26%) 10 (20%) *Circumferential Resection Margin; **Anterior Resection (Guillou et al. Lancet 2005;365: )

18 CLASSIC Trial: Long Term Outcomes 3 year results 794 patients (526 laparoscopic; 268 open) NO difference in 3 year survival Differences in Survival Overall survival: 1.8% Disease free Survival: -1.4% Local recurrence: -0.8% (Jayne et al. J Clin Oncol 2007;25(21):3061-8)

19 Randomized trial comparing lap and open surgery in patients with Rectal cancer 204 patients Mid and low rectal cancers Stage II and III 103 laparoscopic 101 open Blood loss: > for open surgery Return of GI function and discharge: Quicker in lap group Complications and circumferential margins: no difference Number of lymph nodes > in lap group NO difference: Local recurrence Overall survival Disease free survival (Valero et al. Br J Surg 2009;96(9): 982-9)

20 Cochrane Review: Laparoscopic versus open total mesorectal excision for rectal cancer Search from Jan 1990-Dec studies total; 48 included 4224 patients 3 grade 1b studies (individual randomized trials) 12 grade 2b studies (individual cohort studies) 5 grade 3b studies (case control studies) 28 grade 4 studies (case series) Only one randomized control trial with 3 and 5 year follow up. (Breukink et al Cochrane Database System Rev (4):CD005200)

21 Laparoscopic Resection of Rectosigmoid Cancer Prospective randomized study year follow up 403 patients randomized Conversion rate 23.2% (Leung et al. Lancet 2004;363: )

22 Laparoscopic Resection of Rectosigmoid Cancer Laparoscopic Open Patients, n Direct Cost ($) Lymph nodes (#) Distal Margin (cm) OP time (min) EBL (cc) Complications, n Incisional hernia, n 8 4 (Leung et al. Lancet 2004;363: )

23 Laparoscopic Resection of Rectosigmoid Cancer Laparoscopic Open Patients, n year survival 76.1% 72.9% 5 year disease free 75.3% 78.3% (Leung et al. Lancet 2004;363: )

24 Cochrane Review: Laparoscopic versus open total mesorectal excision for rectal cancer Three and five year survival (17 studies): No difference (5 year survival: 63% to 92.1%) Local recurrence (31 studies): No difference (3.75% to 6.8%) Mortality (37 studies):no difference (0-2%) Morbidity (36 studies):no difference (6-37.6%) Anastomotic leak:no difference (0.5-37%) (Breukink et al Cochrane Database System Rev (4):CD005200)

25 Cochrane Review: Laparoscopic versus open total mesorectal excision for rectal cancer Laparoscopic TME had significant benefit in: Blood loss GI recovery rate Post operative pain score Postoperative analgesia Immunological response Length of stay (Breukink et al Cochrane Database System Rev (4):CD005200)

26 Cochrane Review: Laparoscopic versus open total mesorectal excision for rectal cancer Open TME had significant benefit in: Duration of surgery Cost (only one study) (Breukink et al Cochrane Database System Rev (4):CD005200)

27 Port Placement

28 Evisceration and resection

29 Lap TME Specimen

30 Questions How do we deal with the distal and mid rectum? Is it safe to leave the mesorectum?

31 Laparoscopic TATA: Laparoscopic Transanal Transabdominal Approach 79/102 patients Excluded: Stage IV Tumors 3 cm from the anorectal ring No neoadjuvant therapy Mean follow up: 34.2 months Conversion ratel: 2.5% Morbidity: Major: 11% Minor:19% Local Recurrence: 2.5% Distant Recurrence: 10.1% (Marks J et al. Surg Endosc 2010 Nov 24(11):2700-7)

32 Transanal Endoscopic Microsurgery/TAMIS Trans anal excision TEM superior to standard? TAMIS Equivalent Risk of lymph node metastasis Recurrence T stage T1 lesions T2 lesions T2 after neoadjuvant therapy

33 Transanal Endoscopic Microsurgery vs. Laparoscopic Total Mesorectal Excision for T2N0 Rectal Cancer. 78 patients T2N0 tumors Median follow up 70 months Morbidity less in TEM (p=0.001 TEM TEM+RT Laparoscopic n Recurrence 26% 0% 9% ( Allax ME et al. J Gastrointest Surg 2012 Oct 16 epub)

34 TAMIS: Feasibility of transanal minimally invasive surgery for mid-rectal lesions. 16 patients 3 T1 8 S/P neoadjuvant therapy 4 neuroendocrine 1 mucocele TAMIS technique 7.5 cm from the anal verge (4-10cm) No morbidity or mortality LOS: 3 days (Lim SB et al. Surg Endosc Nov 2012;26(11): )

35 Robots =

36 Positioning, Tucking, Securing

37 Port Placement 5-12 mm lap port 8 mm robot port 5 mm lap port

38 Port Placement Fee t Hea d

39 Short term Outcomes: Proctectomy Retrospective study patients robotic proctectomy Low and Mid rectal cancer except T4-22 LAR - 11 inter-sphincteric - 6 APR Complications - 0% mortality % morbidity % anastomotic leak Median OR time 285 minutes Conversion rate 2.6 % Median hospital stay 4 days All negative circumferential margin Median 13 LN removed No local recurrence: median follow-up 13 months (Pigazzi et al. Ann Surg Oncology 2007.)

40 Robotic Proctectomy: 3 Year Follow Up 64 patients (Stage l lll) Mean OR time: 270 min Conversion rate: 9.4% Anastamotic leak: 4/52 (7.7%) Median lymph nodes: 14.5 Median distal margin: 3.4 cm Circumferential margins: - Recurrence: Local: 2/64 (3%) Overall: 6/64 (9%) 3 year overall survival: 96.2% 3 year disease free survival: 73.7% (Baek et al. Ann Surg 2010 May: 251(5):882-6)

41 Robot-Assisted Laparoscopic Surgery of the Colon and Rectum Review of Literature for Robotic colon and rectal surgery 39 studies 13 ileocecal resections 220 right colectomies 190 left colectomies/sigmoid resection 440 anterior resections 149 APR/intersphincteric resections 11 subtotal colectomies (Stavros et al. Surg Endosc :1-11)

42 New da Vinci Technology for Colorectal Surgery EndoWrist One Vessel Sealer EndoWrist Stapler* EndoWrist Suction Irrigator Firefly Fluorescence Imaging Seal & cut up to 7mm diameter vessels Compact snakewrist architecture Full control from the surgeon console Articulation: 60º pitch, 25ºyaw 45mm jaw (white, green & blue re-loads) 13mm diameter instrument Full control from the surgeon console Multi-purpose instrument: -Suction, Irrigation, - Ideal 3 rd arm instrument Articulating tip Full control from the surgeon console or bedside assistant Intra-operative fluorescence visualization Indocyanine green Vasculature identification and soft tissue perfusion PN Rev C 06/12 * 510K application is pending

43 Robotic Rectal Publications Population Complication Rate Conversion Rate LOS (days) CRM Positive Margin Baik SH (2009) % 0.0% % Bianchi (2010) % 0.0% % Park (2010) % 0.0% % Patriti (2009) % 0.0% % Pigazzi (2010) % 7.3% % Choi GS (2010) % 0.0% % Pigazzi (2007) % 2.6% % Pigazzi, Luca (2010) % 4.9% % Kim SH (2009) % 0.0% % Prasad LM (2010) % 3.9% % Robotic (weighted average) % 2.5% % PN Rev C 06/12

44 Robot-Assisted Laparoscopic Surgery of the Colon and Rectum Conversion rate Morbidity Right 1.1% 13.4% Left 3.8% 15.1% Anterior resection 0.4% 9.7% (Stavros et al. Surg Endosc :1-11)

45 HYBRID LAPAROSCOPIC ROBOTIC PROCTOCOLECTOMY

46 SILS Minimal data Retrospective small series and case reports No definitive benefit over other MIS techniques Most data on Right colectomies for colon cancer

47 TABLE 1 Feasibility and Safety of Single-Incision Laparoscopic Colectomy: A Systematic Review. Makino, Tomoki; MD, PhD; Milsom, Jeffrey; Lee, Sang Annals of Surgery. 255(4): , April DOI: /SLA.0b013e31823fbae7 TABLE 1 -a. Perioperative Parameters of Single-Incision Laparoscopic Colorectal Surgery: Included Studies 2012 Lippincott Williams & Wilkins, Inc. Published by Lippincott Williams & Wilkins, Inc. 2

48 TABLE 3 TABLE 3. Postoperative Recovery of Single-Incision Laparoscopic Colectomy Feasibility and Safety of Single-Incision Laparoscopic Colectomy: A Systematic Review. Makino, Tomoki; MD, PhD; Milsom, Jeffrey; Lee, Sang Annals of Surgery. 255(4): , April DOI: /SLA.0b013e31823fbae Lippincott Williams & Wilkins, Inc. Published by Lippincott Williams & Wilkins, Inc. 2

49 The Future To boldly go where no man has gone before Captain James T. Kirk Steel isn t the answer to a systemic biological disease Gershon Efron MD

50 NOTES:Mini-laparoscopy-assisted transrectal low anterior resection (LAR): a preliminary study. 3 patients One 10 mm port, one 5 mm port, one 2mm port Transanal TME Double purse string stapled anastamosis. LOS: 5 days 1 patient readmitted for dehydration (Lacy A et al. Surg Endosc 2012 Jul 18, E pub)

51 Incisionless: No Surgery Predictors of complete response Tumor markers Inflammatory markers Treatment regimine Adequate post treatment assessment: determine cpr MRI PET/CT Endoscopy

52 Watch and Wait: Habr-Gama Evaluation and Treatment T2/T3 lesions Chemo Radiation therapy 12 week observation Assessment of ccr Physical Exam Endoscopy CEA CT scan Excisional Biospy MRI Every month Follow up Rigid proctoscopy Digital exam CEA CT scan Every 6 weeks to 6 Months PET/CT MRI

53 Watch and Wait: Habr-Gama Year n T2 FU months Chem ccr LR yes 36 FU/FA 30.5% 27% FU/FA 26.8% 3% FU/FA 27.3% 3% FU/FA 27.4% 5% FU based 38.7% 4.6% (Glynne-Jones R et al. BJS 2012;99: )

54 Watch and Wait: Others Author, year n Radiation Chem ccr LR Rossi, Gy FU/FA 38% 83% Nagakawa, Gy FU/FA 19% NS Lim, Gy 5-FU 56% 23% Hughes, Gy FU/FA 17% 60% Seshadri, Gy 5-FU/mmc - 43% Dalton, Gy Capecit 24% 50% Yu, Gy Capecit None 41% Maas, Gy Capecit 10.9% 5% Total % (Glynne-Jones R et al. BJS 2012;99: )

55 Where we stand Some evidence to suggest similar oncological results when comparing MIS to open TME. Evidence to show benefits seen with other MIS colectomy procedures. Guidelines for laparoscopic colectomies for cancer should be extrapolated Possibly avoid in obese patients or those with large bulky tumors. Requires advance laparoscopic and colorectal experience Preliminary Data on Watch and Wait Needs Replication

56 Where are we going? Need randomized trials to confirm suspicions. Japan: JCOG 0404 Randomized trial comparing lap and open colon and rectal cancer Color II International randomized trial comparing lap and open rectal cancer US ACOSOG funded trial 500 patient randomized trial comparing lap and open rectal resections Multicenter Prospective Data Base on Watch and Wait Patients Robotic Prospective Trials International/Korea

57 Johns Hopkins Hospital Opened 1883 Johns Hopkins Hospital: New Clinical Buildings Opened April 30, 2012 December 19,

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