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Role of Lap surgery in
colorectal cancer
DEPARTMENT OF SURGICAL GASTROENTEROLOGY
KING GEORGE’S MEDICAL UNIVERSITY
LUCKNOW, INDIA
History
• First reports of LAP for colon CA in 1990
• First series : Jacobs – 1991 of 20 colonic resection
• Technically difficult and challenging
• Time consuming
• Has led to resistance among surgeons to learn the technique
• Short-term benefits (pain, ileus, hospitalization) have not been
pronounced compared to open surgery
Port Site Recurrence
• 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
Port Site Recurrence Rates
Mid 1990’s
Study Year Recurrences Operations Percent
Ramos 1994 3 208 1.4
Jacquet 1995 7 445 1.6
Lumley 1996 1 103 1.0
Kwok 1996 1 100 1.0
Fleshman 1996 4 372 1.1
Franklin 1996 0 191 0
Vukasin 1996 5 480 1.1
Huscher 1996 0 146 0
Total 21 2045 1.0 %
*Series greater than 100 patients
Hughes ’83, Reilley ’96 : Incisional recurrence 0.6 – 0.8 % in open surgery
Port Site Recurrence Rates
Study Year
Operation
s
Recurrenc
es
Percent
Milsom 1998 55 0 0
Schiede
c
1999 399 1 0.25
Regadas 1999 470 2 0.4
Lechaux 2002 206 1 0.5
Lumley 2002 181 1 0.6
Lacy 2002 106 1 0.1
COST 2004 435 2 0.5
Total 1852 8 0.4%
First Randomized Colectomy Trial
Preliminary Report
• Cleveland Clinic Foundation
• n=109 (55 LAP vs. 54 Open)
• Median FU: 17 months (range 1.5 –46)
• No port site recurrences
• Similar number of cancer-related deaths
*Milsom, JACS 1998
Cleveland Clinic Trial
• Less narcotic use *
• Earlier return of flatus (3.0 vs. 4.0 days) *
• Earlier return of FEV1 and FVC to 80% of pre-op
(3.0 vs. 6.0 days) *
Short term advantages to LAP
* p < 0.05
The Barcelona Trial
• Lacy et al, 1993 – 1998
• Single institution, two surgeons
• All non-metastatic colon cancer
• n=219 (111 LAP vs. 108 Open)
• Intention to treat analysis
• Median FU: 43 months (range 27 - 85)
Tumor recurrence
Time to recurrence (mo)
Overall mortality
Cancer-related mortality *
18 (17%)
15 (14)
19 (18%)
10 (9%)
28 (27%)
17 (12)
27 (26%)
21 (21%)
LAP Open
Lacy AM, Lancet 2002
Tumor Recurrence and Mortality
: p < 0.05*
COST* Study Group
Randomized Prospective Study
• Nelson, et al.
• Non-inferiority randomized trial
• 48 institutions, USA and Canada
• n=872 (1994 – 2001)
• Median FU: 4.4 years
• Primary endpoint: Time to tumor recurrence
*Clinical Outcomes of Surgical Therapy Study Group
Nelson, NEJM, May 2004
Survival and Recurrence
Cost Trial
LAP (n=435)
Open
(n=428)
P
value
Tumor recurrence 76 (17 %) 84 (19 %) NS*
Overall survival 79% 78% NS*
Disease-free
survival
73% 73% NS*
Time to recurrence NS*
Wound recurrences 2 (0.5 %) 1 (0.2 %) NS
* True for any stage
Short Term Results
Cost Trial
LAP Open P value
Hospital stay (days) 5 6 <0.001
IV narcotics (days) 3 4 <0.001
Oral narcotics (days) 1 2 <0.001
OR time (min) 150 95 <0.001
Incision length (cm) 6 18 <0.001
Overall complications (%) 92 (21) 85 (20) 0.64
Intraop complications (%) 16 (4) 8 (2) 0.10
Surgical margins, # of LN’s similar
COST Trial Conclusions
• LAP is not oncologically inferior to Open
• Marginal short term benefits seen with LAP in post-
operative recovery
• Similar complications rates (LAP vs. Open)
• “… it is safe to proceed with laparoscopically
assisted colectomy in patients with cancer.”
Results
• COST trial results substantiate results found in other trials
• LAP for colon CA is oncologically safe
• Small benefits are seen in post-operative recovery with LAP
• With good surgical technique, the rate of port site recurrences is minimal
COLOR Trial
• 1997-2003, 29 centers in Europe
• Over 600 patients in each group
• Less pain, blood loss, earlier recovery of bowel
function and shorter hospital stay in Lx group
• 17 % conversion rates
• Equivalent morbidity and mortality
Lancet 2005
CLASICC Trial
• 1996-2002, 27 UK centers
• 794 patients
• Less pain and shorter hospital stay in Lx group
• 29 % conversion rates
• Equivalent morbidity and mortality
• Increase positive radial margins in LX group
• Converted patients had raised complication rates
Lancet 2005
Evidence for rectal Cancer
MRC CLASSIC TRIAL
Short-term endpoints of conventional versus laparoscopicassisted surgery in patients with
colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial
Guillou P J et al. Lancet 2005; 365: 1718–26
MRC CLASSIC – long term results
Long-term follow-up of the Medical Research Council CLASICC trial of conventional versus
laparoscopically assisted resection in colorectal cancer.
B L Green, H C Marshall, F. Collinson, P Quirke, P Guillou, D G Jayne and J M Brown
British Journal of Surgery 2013; 100: 75–82
COREAN Trial
Open versus laparoscopic surgery for mid-rectal or low-rectal cancer after
neoadjuvant chemoradiotherapy (COREAN trial): survival outcomes of an open-
label, non-inferiority, randomised controlled trial
Jeong S Y et al, The Lancet Oncology, Volume 15, Issue 7, Pages 767 - 774, June
2014
Laparoscopic resection for locally advanced rectal cancer after preop CRT
-similar outcomes for disease-free survival as open resection
- comparable short term and long term outcomes
- similar oncological resections
Open versus laparoscopic surgery for mid or low rectal cancer after neoadjuvant
chemoradiotherapy (COREAN trial): short-term outcomes of an open-label randomised
controlled trial.
Kang SB et al, The lancet Oncology, 2010 Jul;11(7):637-45
COLOR II TRIAL
Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes
of a randomised, phase 3 trial
Martijn H G M et al. Lancet Oncol 2013; 14: 210–18
… Concerns
• Impact of Conversion ?
• CRM Positivity
• Bladder/ Sexual Functions
CRM Positivity
Sexual functions
• CLASSIC - males : 41%(Lap) vs 23 % ( open)
females: 28%(Lap) vs 17 %(open)
COLOR II – QLQCR 38 – similar quality of life
COREAN – less micturition problems in lap
“ no distinct advantage”
Emerging dilemma!
• ACOSOG Z6051 trial
• ALaCaRT Trial
• A novel combined score of distal margin, CRM, and LN status
• Both unable to claim non inferiority of laparoscopy over open surgery for rectal cancer
• Ultimately, surrogate markers of quality only become relevant if they indeed predict long-term oncological
outcomes.
JAMA, 2015. 314(13): p. 1346-55
JAMA, 2015. 314(13): p. 1356-63
Lap vs open surgery in rectal cancer
Robotic surgery
Evolution
• FDA approval in 2000
• da Vinci models -modified regularly.
• The current model, da Vinci Xi - 2014
• easier docking
• a wider range of motion
• smaller thinner arms
• better access to different anatomical regions.
• da Vinci Table Motion
• As of December 2017, the number of installed da Vinci series was
4409 throughout the world, including 579 in Asia
Learning curve
• cumulative sum method
• RALS for rectal cancer- 15–44
• the learning curve of laparoscopic rectal surgery -40–90 cases
History
• Weber - first robotic‐assisted colectomy for benign disease in 2001.
• Pigazzi- reported the first robotic‐assisted TME in 2006.
COST
• As high as three times than that of laparoscopic surgery
• A comparative cost-effective study by Ramji et al.
• Robot>open>lap
• cost-effectiveness of robotic surgery for colorectal cancer has not
been demonstrated
current evidence
obese patients (body mass index of ≥30 kg/m2) and male patients with a
narrow pelvis
• lower conversion rates to OS
• a shorter operative time
• less blood loss
• shorter length of hospital stay.
…. NEW CONCEPTS
Laparoscopic intersphincteric dissection (ISR)
• Sphincter-preserving for T1
T2 low rectal cancers
• Acceptable oncologic and
functional results
• APR Vs CRT  ISR in
selected patients
Weiser et al, 2009
Satoshi Nagayama et al, 2008
ST-
ISRT-ISR
P-ISR
Intersphincteric
space
Resection
line
Resection
line
…. NEW CONCEPTS
Laparoscopic extralevator APR (eLAPE)
Less CRM involvement and IOP
West NP et al 2010
↓ local recurrence but not distant mets
Decrease general QoL
↑rate of perineal wound complications
Genitourinary functions often impaired
Welsch T etal 2013
Thank you

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Role of lap surgery in colorectal cancer treatment

  • 1. Role of Lap surgery in colorectal cancer DEPARTMENT OF SURGICAL GASTROENTEROLOGY KING GEORGE’S MEDICAL UNIVERSITY LUCKNOW, INDIA
  • 2. History • First reports of LAP for colon CA in 1990 • First series : Jacobs – 1991 of 20 colonic resection • Technically difficult and challenging • Time consuming • Has led to resistance among surgeons to learn the technique • Short-term benefits (pain, ileus, hospitalization) have not been pronounced compared to open surgery
  • 3. Port Site Recurrence • 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
  • 4. Port Site Recurrence Rates Mid 1990’s Study Year Recurrences Operations Percent Ramos 1994 3 208 1.4 Jacquet 1995 7 445 1.6 Lumley 1996 1 103 1.0 Kwok 1996 1 100 1.0 Fleshman 1996 4 372 1.1 Franklin 1996 0 191 0 Vukasin 1996 5 480 1.1 Huscher 1996 0 146 0 Total 21 2045 1.0 % *Series greater than 100 patients Hughes ’83, Reilley ’96 : Incisional recurrence 0.6 – 0.8 % in open surgery
  • 5. Port Site Recurrence Rates Study Year Operation s Recurrenc es Percent Milsom 1998 55 0 0 Schiede c 1999 399 1 0.25 Regadas 1999 470 2 0.4 Lechaux 2002 206 1 0.5 Lumley 2002 181 1 0.6 Lacy 2002 106 1 0.1 COST 2004 435 2 0.5 Total 1852 8 0.4%
  • 6. First Randomized Colectomy Trial Preliminary Report • Cleveland Clinic Foundation • n=109 (55 LAP vs. 54 Open) • Median FU: 17 months (range 1.5 –46) • No port site recurrences • Similar number of cancer-related deaths *Milsom, JACS 1998
  • 7. Cleveland Clinic Trial • Less narcotic use * • Earlier return of flatus (3.0 vs. 4.0 days) * • Earlier return of FEV1 and FVC to 80% of pre-op (3.0 vs. 6.0 days) * Short term advantages to LAP * p < 0.05
  • 8. The Barcelona Trial • Lacy et al, 1993 – 1998 • Single institution, two surgeons • All non-metastatic colon cancer • n=219 (111 LAP vs. 108 Open) • Intention to treat analysis • Median FU: 43 months (range 27 - 85)
  • 9. Tumor recurrence Time to recurrence (mo) Overall mortality Cancer-related mortality * 18 (17%) 15 (14) 19 (18%) 10 (9%) 28 (27%) 17 (12) 27 (26%) 21 (21%) LAP Open Lacy AM, Lancet 2002 Tumor Recurrence and Mortality : p < 0.05*
  • 10. COST* Study Group Randomized Prospective Study • Nelson, et al. • Non-inferiority randomized trial • 48 institutions, USA and Canada • n=872 (1994 – 2001) • Median FU: 4.4 years • Primary endpoint: Time to tumor recurrence *Clinical Outcomes of Surgical Therapy Study Group Nelson, NEJM, May 2004
  • 11. Survival and Recurrence Cost Trial LAP (n=435) Open (n=428) P value Tumor recurrence 76 (17 %) 84 (19 %) NS* Overall survival 79% 78% NS* Disease-free survival 73% 73% NS* Time to recurrence NS* Wound recurrences 2 (0.5 %) 1 (0.2 %) NS * True for any stage
  • 12. Short Term Results Cost Trial LAP Open P value Hospital stay (days) 5 6 <0.001 IV narcotics (days) 3 4 <0.001 Oral narcotics (days) 1 2 <0.001 OR time (min) 150 95 <0.001 Incision length (cm) 6 18 <0.001 Overall complications (%) 92 (21) 85 (20) 0.64 Intraop complications (%) 16 (4) 8 (2) 0.10 Surgical margins, # of LN’s similar
  • 13. COST Trial Conclusions • LAP is not oncologically inferior to Open • Marginal short term benefits seen with LAP in post- operative recovery • Similar complications rates (LAP vs. Open) • “… it is safe to proceed with laparoscopically assisted colectomy in patients with cancer.”
  • 14. Results • COST trial results substantiate results found in other trials • LAP for colon CA is oncologically safe • Small benefits are seen in post-operative recovery with LAP • With good surgical technique, the rate of port site recurrences is minimal
  • 15. COLOR Trial • 1997-2003, 29 centers in Europe • Over 600 patients in each group • Less pain, blood loss, earlier recovery of bowel function and shorter hospital stay in Lx group • 17 % conversion rates • Equivalent morbidity and mortality Lancet 2005
  • 16. CLASICC Trial • 1996-2002, 27 UK centers • 794 patients • Less pain and shorter hospital stay in Lx group • 29 % conversion rates • Equivalent morbidity and mortality • Increase positive radial margins in LX group • Converted patients had raised complication rates Lancet 2005
  • 17.
  • 19. MRC CLASSIC TRIAL Short-term endpoints of conventional versus laparoscopicassisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial Guillou P J et al. Lancet 2005; 365: 1718–26
  • 20. MRC CLASSIC – long term results Long-term follow-up of the Medical Research Council CLASICC trial of conventional versus laparoscopically assisted resection in colorectal cancer. B L Green, H C Marshall, F. Collinson, P Quirke, P Guillou, D G Jayne and J M Brown British Journal of Surgery 2013; 100: 75–82
  • 21. COREAN Trial Open versus laparoscopic surgery for mid-rectal or low-rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): survival outcomes of an open- label, non-inferiority, randomised controlled trial Jeong S Y et al, The Lancet Oncology, Volume 15, Issue 7, Pages 767 - 774, June 2014 Laparoscopic resection for locally advanced rectal cancer after preop CRT -similar outcomes for disease-free survival as open resection - comparable short term and long term outcomes - similar oncological resections Open versus laparoscopic surgery for mid or low rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): short-term outcomes of an open-label randomised controlled trial. Kang SB et al, The lancet Oncology, 2010 Jul;11(7):637-45
  • 22. COLOR II TRIAL Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial Martijn H G M et al. Lancet Oncol 2013; 14: 210–18
  • 23.
  • 24. … Concerns • Impact of Conversion ? • CRM Positivity • Bladder/ Sexual Functions
  • 26. Sexual functions • CLASSIC - males : 41%(Lap) vs 23 % ( open) females: 28%(Lap) vs 17 %(open) COLOR II – QLQCR 38 – similar quality of life COREAN – less micturition problems in lap “ no distinct advantage”
  • 27. Emerging dilemma! • ACOSOG Z6051 trial • ALaCaRT Trial • A novel combined score of distal margin, CRM, and LN status • Both unable to claim non inferiority of laparoscopy over open surgery for rectal cancer • Ultimately, surrogate markers of quality only become relevant if they indeed predict long-term oncological outcomes. JAMA, 2015. 314(13): p. 1346-55 JAMA, 2015. 314(13): p. 1356-63
  • 28. Lap vs open surgery in rectal cancer
  • 30. Evolution • FDA approval in 2000 • da Vinci models -modified regularly. • The current model, da Vinci Xi - 2014 • easier docking • a wider range of motion • smaller thinner arms • better access to different anatomical regions. • da Vinci Table Motion • As of December 2017, the number of installed da Vinci series was 4409 throughout the world, including 579 in Asia
  • 31. Learning curve • cumulative sum method • RALS for rectal cancer- 15–44 • the learning curve of laparoscopic rectal surgery -40–90 cases
  • 32. History • Weber - first robotic‐assisted colectomy for benign disease in 2001. • Pigazzi- reported the first robotic‐assisted TME in 2006.
  • 33. COST • As high as three times than that of laparoscopic surgery • A comparative cost-effective study by Ramji et al. • Robot>open>lap • cost-effectiveness of robotic surgery for colorectal cancer has not been demonstrated
  • 34.
  • 35.
  • 36.
  • 37. current evidence obese patients (body mass index of ≥30 kg/m2) and male patients with a narrow pelvis • lower conversion rates to OS • a shorter operative time • less blood loss • shorter length of hospital stay.
  • 38. …. NEW CONCEPTS Laparoscopic intersphincteric dissection (ISR) • Sphincter-preserving for T1 T2 low rectal cancers • Acceptable oncologic and functional results • APR Vs CRT  ISR in selected patients Weiser et al, 2009 Satoshi Nagayama et al, 2008 ST- ISRT-ISR P-ISR Intersphincteric space Resection line Resection line
  • 39. …. NEW CONCEPTS Laparoscopic extralevator APR (eLAPE) Less CRM involvement and IOP West NP et al 2010 ↓ local recurrence but not distant mets Decrease general QoL ↑rate of perineal wound complications Genitourinary functions often impaired Welsch T etal 2013

Notas do Editor

  1. Controversy however has risen due to the publication of the ACOSOG Z6051 and ALaCaRT Trials suggesting that a novel combined score of distal margin, CRM, and LN status may indeed be worse than open surgery
  2. Three types based on distal resection line of the internal anal sphincter (IAS) : At the dentate line (DL) (1) in partial ISR Between the DL and the intersphincteric groove (ISG) (2) in subtotal ISR, and At the ISG (3) in total ISR. Coloanal anastomosis is performed using a transanal handsewn technique. An ultralow, anterior resection of the rectum using a double-stapling technique is not regarded as an ISR.