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Rectal cancer  surgery trials
Rectal cancer surgery trials
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Colorectal updates

  2. 2. PROF.S.SUBBIAH Prof. Subbiah Shanmugam M.Ch Professor and HOD Dept of Surgical Oncology Government Royapettah Hospital
  6. 6. PROF.S.SUBBIAH Introduction • Treatment options for colorectal cancer are evolutionally changing, even in the last few years • Screening • Surgical advances • Chemotherapy - targetted therapy • Chemoprevention? • Radiation updates
  11. 11. PROF.S.SUBBIAH What is new in colonoscopy? • The third most common form of cancer worldwide — relies heavily on colonoscopies. • Traditional colonoscopies are expensive, painful and require high levels of skills. • New approaches – magnetic probes precisely controlled by a robotic arm, which allows for complex movement inside the body. – Still complicated and requires high level training.
  12. 12. PROF.S.SUBBIAH Semi-automated robotic system • James Martin, Bruno Scaglioni • Simple movement commands from the user. • The probe moves using machine intelligence and image analysis to automatically guide itself along the colon.
  13. 13. PROF.S.SUBBIAH
  14. 14. PROF.S.SUBBIAH Sensors and scopies
  15. 15. PROF.S.SUBBIAH
  16. 16. PROF.S.SUBBIAH History • First reports of LAP for colon CA in 1990 - JACOBS • Short-term benefits (pain, ileus, hospitalization) have not been then pronounced compared to open surgery • PSR has led to resistance among surgeons to learn the technique
  17. 17. PROF.S.SUBBIAH Port site Recurrence • Definition: 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
  18. 18. PROF.S.SUBBIAH
  19. 19. PROF.S.SUBBIAH Results • LC took significantly longer Operating time (median 145 vs. 115 min; p-0.0001) • Significantly less blood loss (median 100 vs. 175 mL; P-0.0001). • Conversion rate was 17%, mainly due to bulky tumors and extensive adhesions. • Postoperative length of stay was 1.1 days shorter after LC (mean 8.2 vs. 9.3 days; p0.0001).
  20. 20. PROF.S.SUBBIAH • Pathological outcomes- no difference between the two groups. • Long-term oncologic evaluation revealed no significant differences in DFS, OS, and recurrence. • Low volume centers and High volume centers • Similar to Barcelona and COST trials
  21. 21. PROF.S.SUBBIAH Robotic vs lap colectomy.? ● Only observational cohort studies. ● In general, the robotic approach ● longer operating times and is more expensive ● Less blood loss, shorter time to recovery of bowel function, shorter hospital stays, and lower rates of complications and infections.
  22. 22. PROF.S.SUBBIAH CME - Concept of improved resections? ● Hohenberger- Complete Mesocolic Excision- Germany ● Dissection within embryological planes of dorsal mesentery yields a scatheless specimen. ● Analogous toTME concept by Heald et al. ● Mesocolon = dorsal mestentery. ● Visceral and parietal peritoneum covers the colon like a sheath ● Submesothelial connective tissue and interlobular septations.
  23. 23. PROF.S.SUBBIAH Surgical Colonic Interfaces ● Extra fascial plane between the mesocolon and retroperitoneum = “Toldt’s Fascia”. ● (I) “Colo-fascial interface” - confluence of colonic surface and “Toldt’s Fascia” ● (II) “Meso-fascial interface” confluence of mesocolon and “Toldt’s Fascia” ● (III) “Retro-fascial interface” confluence of retroperitoneum and “Toldt’s Fascia”
  24. 24. PROF.S.SUBBIAH
  25. 25. PROF.S.SUBBIAH CME vs Non CME colectomy? ● Japan (D3 lymphadnectomy) and Germany (CME + CVL). ● Complete mesocolic excision (CME) with central vascular ligation resulted in greater mesentery and lymph node yields than the Japanese D3 high tie surgery. ● Disadvantages - Differences in outcomes were not reported.
  26. 26. PROF.S.SUBBIAH Other supportive evidences for CME with CVL ● A retrospective, population based study in Denmark also supports the benefit of a CME approach in patients with stage I–III colon cancer, with a significant difference in 4-year DFS (P = .001) between those undergoing CME resection (85.8%; 95% CI, 81.4–90.1) and those undergoing conventional resection (75.9%, 95% CI, 72.2–79.7). ● A systematic review found that 4 of 9 prospective studies reported improved lymph node harvest and survival with CME compared with non-CME colectomy; the other studies reported improved specimen quality.
  27. 27. PROF.S.SUBBIAH CME- LAP or Open?
  28. 28. PROF.S.SUBBIAH
  29. 29. PROF.S.SUBBIAH To drain or not to drain colorectal anastamosis?
  30. 30. PROF.S.SUBBIAH Stenting in Obstructed colon? • Left sided colonic carcinoma. • ESCO trial • In medically inoperable or metastatic patients.
  31. 31. PROF.S.SUBBIAH RECTAL CANCER- Evolving trends
  32. 32. PROF.S.SUBBIAH
  33. 33. PROF.S.SUBBIAH Rectal cancer- where do we stand? • Revolutionary last thirty years. • Previously, local relapses in the pelvis in 30% LARC. • 1st step to improve local control = Total mesorectal excision (Reducing local relapses to less than 5%). • 2nd step = Preoperative radiation (short course Vs long course with CCRT).
  34. 34. PROF.S.SUBBIAH Rectal cancer- what is known now? • Magnetic resonance imaging = useful tool for locoregional staging and for properly selecting patients for preoperative treatment (Mercury trial). • Nowadays, we know that preoperative Total neoadjuvant (TNT) with chemotherapy also provides better control of systemic relapses(RAPIDO and Rect 03 trial). • Moreover, surgery can be avoided in 25% of patients and the “watch and wait strategy” is considered safe and curative (Habr Gama).
  35. 35. PROF.S.SUBBIAH
  36. 36. PROF.S.SUBBIAH EVOLUTION • The recurrence rate of rectal cancer varied between 4 to 50% • The main cause remained unproven in patients with curative resection.
  37. 37. PROF.S.SUBBIAH (1) Recognition of mobility between tissues of different embryological origins (2) Sharp dissection under direct vision in a good light (3) Gentle opening of the plane by continuous traction with no actual tearing.  DEFINE AN OPTIMAL DISSECTION PLANE around the cancer which must clear all forms of extension and circumscribe predictably uninvolved tissues. ‘  “the whole rectum and mesorectum are one distinct lymphovascular entity”
  38. 38. PROF.S.SUBBIAH • Circumferential resection margin (CRM) is the closest distance between the radial resection margin and the tumor tissue by either direct tumor spread, areas of neural or vascular invasion, or the nearest involved lymph node.
  39. 39. PROF.S.SUBBIAH Total Mesorectal Excision
  40. 40. PROF.S.SUBBIAH Total Mesorectal Excision • The intramural spread of cancer downward is very rare, but extramural spread appears both in distal and anterior directions. • Anatomically three spaces can be distinguished around the rectum. • The inner space is surrounded by a visceral fascia on the posterior side, and Denonvillier’s fascia on the front of the rectum. – Laterally they unite and are related to nerve plexus • Intermediate space is limited by the parietal pelvis fascia on the posterior side and the internal iliac arteries and their branches on both lateral sides, and on the front.
  41. 41. PROF.S.SUBBIAH
  42. 42. PROF.S.SUBBIAH
  43. 43. PROF.S.SUBBIAH • The outer space is localized outside the internal iliac arteries and their branches • TME = Removal of the internal space with the visceral fasciation and Denon-Villiers fascia whilst preserving the pelvis nerve plexus on both lateral sides.
  44. 44. PROF.S.SUBBIAH Total Mesorectal Excision- Mercury Criteria
  45. 45. PROF.S.SUBBIAH
  46. 46. PROF.S.SUBBIAH • TME should be performed to a level of 5 cm below the distal margin of the primary tumour in the upper rectum or to the pelvic floor (complete TME) for tumours in the lower or middle rectum. • A minimum negative proximal margin of 5 cm is required • The minimum acceptable negative distal margin is 2 cm for cancers located above the distal meso-rectal margin. For cancers located at or below the distal meso-rectal margin, a 1 cm negative distal margin is acceptable. What remains the gold standard in surgery?
  47. 47. PROF.S.SUBBIAH High TIE Surgery
  48. 48. PROF.S.SUBBIAH 42 and 147 patients were ligated at the origin of the IMA (high tie) and just below the origin of the LCA combined with LND around the origin of the IMA (low tie with LND), respectively. No significant differences were observed in the complication rate and OS and RFS rates between high tie and low tie groups.
  49. 49. PROF.S.SUBBIAH
  50. 50. PROF.S.SUBBIAH Transanal excision/ Transanal endoscopic surgery (TES) • Radical surgery for stage I and II rectal cancer can expect excellent long- term results which approach 5-year local recurrence rates of 4.5 % and 90% 5-year disease free survival (DFS) rates • Morbidity is high (30-68%) with a mortality that approaches 7% in certain pooled studies Journal of Gastro intestinal Oncology 2015
  51. 51. PROF.S.SUBBIAH Criteria for Local rectal excision ? Physical examination:  tumor <3cm  tumor <30% of bowel circumference  tumor within 15cm of dentate line  tumor freely mobile Imaging (ERUS/MRI)  Tumor limited to submucosa(T1)  Lymphnode involvement(N0) Histology:  Well to moderately differentiated  Absence of LVI or PNI  No mucinous or signet ring cell component Journal of Gastro intestinal Oncology 2015
  52. 52. PROF.S.SUBBIAH
  53. 53. PROF.S.SUBBIAH • Local recurrence rates tend to be higher for both T1 (8.2-23%) and T2 adenocarcinomas (13-30%) undergoing LE when compared to radical surgery for T1-T2 disease (3-7.2%). • No significant difference in DFS when compared to radical surgery.
  54. 54. PROF.S.SUBBIAH Postoperative complications of TAE are • Rectal bleeding which is the most common (6%), • Rectal stenosis (5.5%), • urinary retention (1.5%), • fecal incontinence (0.5%), and • rectovaginal fistula (<1%) The most common complications TEM reported are • hemorrhage (27%), • urinary tract infection (21%), and • suture line dehiscence (14%) and • 4.3% conversion to radical procedures Complications following the TAMIS procedure are infrequent with an overall rate of 7.4% with conversion rate of 4%
  55. 55. PROF.S.SUBBIAH NON OPERATIVE MANAGEMENT IN DISTAL RECTAL CANCER • Brazil • Five-year overall and disease-free survival rates were 88% and 83%, respectively, in Resection Group and 100% and 92% in Observation Group • NCCN 2021: • “ In select patients achieving complete clinical response as demonstrated by clinical examination, imaging and endoscopy following neoadjuvant chemo radiotherapy may be advised observation with strict serial monitoring after multidisciplinary team discussion in select high volume centres”
  56. 56. PROF.S.SUBBIAH
  57. 57. PROF.S.SUBBIAH Laparoscopic Vs Open rectal surgeries • Two previous large RCT and several meta- analyses showed similar pathological and oncological outcomes between laparoscopic and open approaches for rectal cancer • The laparoscopic approach was regarded as a standardized alternative to the open approach
  58. 58. PROF.S.SUBBIAH
  59. 59. PROF.S.SUBBIAH • Robotic assistance has the potential to overcome limitations of laparoscopic surgery • Meta analysis - failed to show superiority of robotic assisted over conventional laparoscopic surgery • Safety, efficacy , short and long term outcomes were analysed ( 2017)
  60. 60. PROF.S.SUBBIAH • The primary outcome - conversion to open laparotomy. • Rate of urinary retention was significantly lower in the robotic group than in the laparoscopic group (2.5% vs 7.5%, P = .018). • 28 of 230 patients (12.2%) in the conventional laparoscopic and 19 of 236 patients (8.1%) in the robotic assisted laparoscopic group
  61. 61. PROF.S.SUBBIAH • 701 patients were randomized to the ME with LLND (n = 351) and ME alone (n = 350) groups. ( 2017 Fujita et al ) • The 5-year relapse-free survival in the ME with LLND and ME alone groups were 73.4% and 73.3%, respectively • The 5-year overall survival, and 5-year local-recurrence-free survival in the ME with LLND and ME alone groups were 92.6% and 90.2%, and 87.7% and 82.4%, respectively. • The numbers of patients with local recurrence were 26 (7.4%) and 44 (12.6%) in the ME with LLND and ME alone groups, respectively
  62. 62. PROF.S.SUBBIAH • Ishihara et al reported that the incidence of LLN metastasis was estimated to be 8.1% (18/222) even after preoperative CRT. • Kusters et al reported that the lateral local recurrence rate was significantly higher in patients with LLN larger than 10 mm in pre treatment imaging. • The safety and feasibility of laparoscopic versus open LLND showed similar oncological outcomes between the groups. • Establishment of criteria to accurately predict LLN status as well as standardization of the technique of LLND is necessary in the future
  63. 63. PROF.S.SUBBIAH 228 patients with low rectal cancer <5cm from anal verge between 1996 to 2004 were enrolled 86% successful 24% morbidity and 0.4% mortality Five year overall survival 91.9% and 83.4% DFS Curability with intersphincteric resection was verified histologically, and acceptable oncologic and functional outcomes were obtained by using these procedures in patients with very low rectal cancer.
  64. 64. PROF.S.SUBBIAH
  65. 65. PROF.S.SUBBIAH Liquid biopsy - biopsing your DNA content. • Liquid biopsies are a promising new approach • To detect, analyze, and track DNA, cells, and other substances shed from tumors into bodily fluids, such as blood and urine. • COBRA trial which studies how well circulating tumor DNA (ctDNA) testing in the blood works • To identify patients with stage IIA colon cancer who might benefit from additional treatment with chemotherapy after surgery.
  66. 66. PROF.S.SUBBIAH Aspirin • Recent studies have shown that daily low-dose aspirin may prevent colorectal cancer. • However, there are potential harms, particularly the risk of gastrointestinal bleeding. • Aspirin is currently recommended by the US Preventive Services Task Force (USPSTF)Exit Disclaimer to prevent colorectal cancer and cardiovascular disease in some individuals age 50 to 69.
  67. 67. PROF.S.SUBBIAH Immunotherapy for patients with Lynch syndrome • >5% of CRC • Immune checkpoint inhibitors nivolumab (Opdivo), ipilimumab (Yervoy), and pembrolizumab (Keytruda) have been approved for the treatment of metastatic CRC in patients with Lynch syndrome. • They also have been approved for metastatic CRC in patients with microsatellite instability-high cancer (MSI-H).
  68. 68. PROF.S.SUBBIAH Take home points ● Routine use of minimally invasive colon resection is generally not recommended for tumors that are acutely obstructed or perforated or tumors that are clearly locally invasive into surrounding structures (ie, T4) ● Laparoscopic vs Open colectomy has advantages of laparoscopic interventions with preserved oncologic outcomes. ● CME +CVL is better than High tie surgery ● Lap CME is better than Open CME. ● ERAS protocol for colonic resections- intrinsic advantages to return to near normal life.
  69. 69. PROF.S.SUBBIAH • T1N0 – select patients with low risk features – Local Excision • Other T1,T2 – Radical Abdominal surgery with TME • T3, T4 N+ - Neoadjuvant chemo RT  Surgery • Operable Early rectal cancer – NACRT- not useful due to significant toxicity • LAP > OPEN Radical Rectal Surgery • Evolving – Robotic Surgery , Lateral Node dissections
  70. 70. PROF.S.SUBBIAH • Thank you

Notas do Editor

  • which includes all vascular and lymphatic pathways and lymph nodes.

    HC shows that lymphatic channels within the mesocolon are densely present in both
  • MRI from patients showing locally advanced rectal cancer with high-risk features. (A) Upper
    third rectal cancer with peritoneal reflection invasion (cT4a). (B) Same patient showing extra-mural
    vascular invasion. (C) Lower third rectal cancer in a male with invasion of the anterior part of the
    mesorectal fascia (cT3d) and multiple large size peritumoral lymph nodes (N2) (D).