Innovations in Rectal Cancer Surgery
A. D’Hoore MD PhD, EBSQ-CR, (hon)FASCRSA. Wolthuis MD PhD, EBSQ-CR, FACS
G. Bislenghi MD
Departement of Abdominal SurgeryUniversity Hospitals Leuven, Belgium
No related disclosures
Local recurrence: persistent problem1984-1993 : 99 pts – low/mid rectal cancer
Intraoperative tumor break : 12 (13%) : LRR 45% despite postop RT
APR SSO
LRRat 1 yr 13% 5%at 5 yr 27% 21%
5 yr Survival 61% 67%
Leuven – dataD’Hoore A.
TME - concept
DRM : distal resection margin
CRM : circumferential resection margin
TN
Ejaculation
Erectile dysfunction
Urinary problems
TME quality: standardised method
Quality grading of surgery
Mesorectal plane
Intra-mesocolic plane
Muscularis proproa plane
Correlates with local recurrence and survival
TME implementation rsulted in a significant decrease in APR rate in Belgium
(significant differences remain for distal rectal cancer))
1995 – 1997
50 %2006 – 2009
22 %
Rectal carcinoma
Clinical staging (CT-scan)
Surgeryp staging
Adjuvant chemo - radiotherapy
MRI(DW-MRI)
patient
MD strategy
Radical SurgeryTME +/- proctectomy
Actual treatment in rectal cancer
Early rectal cancer(T1,T2,N0)
Advanced rectal cancer≥ T3, TxN1
Neoadjuvant(chemo)radiotherapy
TEM/TAETAMIS
T1sm1,(sm2)
cCR
“wait and see”organ sparing
MRI good
1
2
Evolution in SurgeryOpen surgery
Laparoscopic surgeryRobotic surgery
SSLNOSE
TAMIS
NOTEStime
EMREndoscopic polypectomy
Endoscopic biopsyDiagnostic endoscopy
inva
sive
ness
recent evidence
disruptiveincremental
Development of laparoscopic surgery
major disruptive change
first CCD-camera
Minimally Invasive surgery in evolution
IBD 2009
Hand-assisted + Pfannenstiehl Total Laparoscopic
COLOR II trial (non-inferiority phase III) 2004-2010
1044 patients randomised (2:1) 699 in laparoscopic surgery group345 in open surgery group
Locoregional recurrence rate at 3 years : 5.0% in both groups
DFS: 74.8% (laparoscopic) and 70.8% (open)
OS : 86.7% (laparoscopic) and 83.6% (open)
N Engl J Med 2015
Disease free survival Overall survival
Factors affecting suitability for lap TME
BMIPelvic anatomy
Previous surgeryCo-morbidity
Preference
T size, fixity, levelAnastomotic level
ExperienceQuality
Assurance
Colorectal Disease 2006; 8 (s3): 30-2
Conversion to laparotomyremains substantial
%
Grafiek1
ROLLAR
COLOR II
CLASSIC
conversions
10.2
17
30
Blad1
CRM positivity
CLASSIC16
COLOR II10.2
ROLLAR5.2
conversions
ROLLAR10.2
COLOR II17
CLASSIC30
Blad1
CRM positivity
conversions
Can robotics reduce conversions ?
Primary endpoint – conversion to open surgery
Lap(n=230)
Robotic(n=236)
Total (n=466)
Difference in rates(95% CI)
Conversion 28 (12.2%) 19 (8.1%) 47 (10.1%) 4.1% (-1.4%, 9.6%)
Overall conversion rate: 10.1%
Lap (n=28) Robotic (n=19)Reasons for intra-op conversion to open*Adhesions 1 (3.6%) 0 (0.0%)Advanced cancer 3 (10.7%) 4 (21.1%)Anaesthetic complication 0 (0.0%) 1 (5.3%)Completion of rectal/pelvic dissection 11 (39.3%) 9 (47.4%)Difficult colonic mobilisation 3 (10.7%) 2 (10.5%)Haemorrhage 3 (10.7%) 3 (15.8%)Obesity 6 (21.4%) 0 (0.0%)Robotic collisions 0 (0.0%) 1 (5.3%)Visceral injury 1 (3.6%) 2 (10.5%)
Pigazzi et al. ASCRS 2015 Boston
becoming more proficient : CRM positivity (%)
Robotic versus laparoscopic TME
Laparoscopic versus open TME
Laparoscopic versus open colon and rectum
Grafiek1
CLASSIC
COLOR II
ROLLAR
CRM positivity
16
10.2
5.2
Blad1
CRM positivity
CLASSIC16
COLOR II10.2
ROLLAR5.2
Blad1
CRM positivity
Understanding the shortcomings oflaparoscopic TME
- Difficult exposure deepest part pelvic dissection- Troublesome distal rectal transection- Uncontrolled distal margin
persistent high conversion to laparotomyIntracorporeal rectal stapling following laparoscopic totalmesorectal excision: overcoming a challenge.Brannigan AE, De Buck S, Suetens P, Penninckx F, D'Hoore A.Surg Endosc. 2006
https://www.ncbi.nlm.nih.gov/pubmed/16738989
Full laparoscopic dissection and transanal specimen extraction (TATA)
……a laparoscopic transanal abdominal transanalradical proctosigmoidectomy and a descending coloanalhandsewn anastomosis (TATA).
Laparoscopic low anterior resection and transanal pull-through for low rectal cancer: a Natural Orifice Specimen Extraction (NOSE) technique.D'Hoore A, Wolthuis AM. Colorectal Dis. 2011 Nov;13 Suppl 7:28-31
.Marks JH, Salem JF.Tech Coloproctol. 2016 Aug;20(8):513-5.
From TATA to notes, how taTME fits into the evolutionary surgical tree
https://www.ncbi.nlm.nih.gov/pubmed/22098514
Transanal Endoscopic Microsurgery( TEM)
Buess G et al. Surg Endosc 1988; 2: 245- 250
A new transanal platform
Endoluminal TAMIS
TEM TAMIS
Transanal TME (taTME)
Conceptual advantage taTMEvisual control of the distal margin
Human Pathol 2016; 52:164-172 distal spread beyond macroscopic tumor edge
Transanal natural orifice transluminal endoscopic surgery(NOTES) rectal resection: ‘‘down-to-up’’ total mesorectalexcision(TME)—short-term outcomes in the first 20 casesAntonio M. Lacy et al. Surg Endoscopy 2013
prostate
S3
R hypogastric nerve
Hybrid, laparoscopic procedure
New technologies
Expanding the applicability of the platform
- no
Transanal endoscopic proctectomyinnovative procedure for difficult resection of rectal tumorsin men with narrow pelvis (n=30, jan 2009- june 2011)
Laparoscopic assisted (splenic flexure)
Main causes for TAEP---
narrow pelvisfatty mesorectumlarge anterior tumor
231422
Morbidityurethral Injuries (n=2,reoperation (n=2, 7%)
7%)
Hospitalization 14d (19-25)Rouanet Ph et al. Dis Colon and Rectum 2013
The bulbar urethra ‘at risk’
Understanding the operative force vectors
Atalah S et al. Techn Coloproctology 2017
Operative vectors, anatomic distortion, fluid dynamics and theinherent effects of pneumatic insufflation encountered duringtransanal total mesorectal excision
Slide courtesy of John Monson
TA-TME Learning Curve - CUSUM
5 urethral injuries2 bladder injuries
1 vaginal perforation1 hypogastric nerve resection
2 macroscopic rectal tube perforations
Ann Surg. 2017; 266(1):111-117
2017
5 urethral injuries2 bladder injuries
1 vaginal perforation1 hypogastric nerve resection
2 macroscopic rectal tube perforations
20182018
1836 cases18.0%
Improved insufflation system in 80% 27% proctored
14 Urethral injuries2 bladder injuries
5 vaginal perforations11 rectal tube perforations
0.6% 0.9%
Incidence Anastomotic FailuretaTME Registry – International database
1594 patients
Overall anastomotic failure rate = 15.7% (and probably underreported)
- early leak rate 7.8%- delayed leak 2.0%
Independent risk factors- male sex - tumorbulk- obesity - intraoperative blood loss- smoking - manual anastomosis- diabetes mellitus - prolonged perineal operative time
Risk for a definitive stoma
11 % 26%
Risk factors : age > 65 yrspreoperative radiotherapyanastomotic morbidity and abscess
Celerier B. et al. Colorectal Dis 2015; 18
2017
Cancer patients (n=634)Quality TME specimen, n(%)
Intact 503 (85%)
Minor defects 65 (11%)
Majors defects 24 (4.1%)
Rectal tube perforations 12 (2%)
Distal Margin (mm)
Mean +/- SD 19 +/- 14.3
Median (range) 15 (0-97)
Positive DRM 2 (0.3%)
Circumferential Resection Margin (mm)
Mean +/- SD 9.2 +/- 8.6
Median (range) 8 (0-90)
Positive CRM 14 (2.4%)
Composite Optimal Pathological Outcome
CRM –, DM –, good specimen
92.6%
2017
20172017
PatientNone
TumourTumour height
Tumour locationmT stage
+ CRM MRIM+
nRCT
TechnicalSimultaneous operating
AR vs APEConversion
Blood loss > 1LExtent post abd dissection
Total operative time
Risk Factors for poor histological outcome after TaTMEUnivariate Analysis
4 Hospitals - 110 TaTME procedrues (2015-2017)
Local recurrences : > 9.5%
median time to recurrence 11 months
rapid, multifocal growth in the pelvis and side walls
Br J surg 2019
Rutgers M et al. (in preparation)
• Dutch Colorectal Audit Database• Mandatory audit• Limited core dataset
• Jan 2015 – dec 2018
• MIS procedure
• Primary low rectal Cancer -> (0-5 cm ARJ)
N= 3466• Lap : 2845• TaTME : 448 • Robot : 173
Patient/Tumour/Tx data
Primary outcome : R1
Secondary outcome- Peri-op morbidity- Conversion- Restorative procedure
ESCP Masterclass Cardiff | November 2019
Rutgers M et al. (in preparation)
0
10
20
30
40
50
60
Lap-LAR LAp-APE TA-LAR TA-APE R-LAR R-APE
complictions< 90 days
0 5 10 15 20 25
Lap-LAR
LAp-APE
TA-LAR
TA-APE
R-LAR
R-APE
anastomotic leakage
Rutgers M et al. (in preparation)
0123456789
Lap-LAR LAp-APE TA-LAR TA-APE R-LAR R-APE
CRM
CRM positivity : APR at risk
APE : optimizing surgical technique“cylindrical APE”
Tissue morphometry
Local recurrence after TaTME – 6 centres*
* Submitted Ann of Surg
• Consecutive TaTME cases from start (2013-2018)• Early adopters – Tertiary referral centres• Prospective kept databases
Oncologic Outcomes – Intermediate term• 2-3 yr LR-free• 2-3 yr DFS• 2-3 yr OS
Local recurrence after TaTME – 6 centres*
N = 767Baseline characteristics N (%)Male gender 72%
BMI >30 20%
Tumor height ARJ, median [IQR]≤ 1 cm
3 [1-5]28%
Anterior tumor 56%
mrCRM positive 41%
Neo-adjuvant therapy
mrTRG 1-2mrTRG 3-5
69%
47%53%
Variable, N (%) N=767
pT-stage ≥ 3 54%
pN-stage ≥ 1 31%
R1Only DRM+Only CRM+DRM+ & CRM+
8%0.7%6.3%
1%
TME quality CompleteNear-complete
Incomplete
81%12%7%
Rectal perforation 1%
Composite optimal pathology* 86%
*Composite optimal pathology: R0 and (near-) complete TME specimen and no perforations
Outcomes (1)
Local recurrence - free
LR 2y : 3.3%LR 3y : 4.4%
Median time to LR: 14 months
LR 2yACOSOG & ALACART:• Lap 4.6% and 5.4%• Open 4.5% and 3.1%
* submitted
Median FU: 25 months
Disease-free survival Overall survival
DFS 3y : 78% OS 3y : 93%
Predicted risk for pCRM+
Case selection learning curveIntensified neo-adjuvant therapyExtended TME / Beyond TME
cT1-3-stage cT4-stage
EMVI on MRI CRM on MRI Tumor >1cm ARJ Tumor ≤1cm ARJ Tumor >1cm ARJ Tumor ≤1cm ARJ
2% 3% 3% 5% 3% 5% 6% 10% 3% 4% 6% 9% 5% 9% 11% 17% 3% 5% 6% 10% 5% 9% 12% 18% 5% 8% 10% 16% 9% 15% 19% 28% not Anterior Anterior not Anterior Anterior not Anterior Anterior not Anterior Anterior
Surgical decision making in rectal cancer = complex
1. Type and extent of primary tumor
2. Response to chemo-radiation
3. Perceived ability to clear all tumor (adequate margins)DRM / CRM
4. Patient related factors (functional status, comorbidity)
5. Patients preferenceacceptance suboptimal functional outcome
Male patient: 75 yrs.Moderate operative risk, ASA 2well differentiated adenocarcinoma,juxta-anal (Rullier II) cT2 (3a) N?, M0
70
Functional outcome and QoL afterTME surgery
Battersby et al, Dis Colon Rectum 2016
Low rectal cancer & Radiotherapy:60% bowel-related QoL Impairment
Intentional organ preservationChemoradiation
Incidental organ preservationChemoradiation +TME = standard
Early, small Advanced tumors
Organ Preservation
> 50% 10-25%
Maas et al , Lancet Oncol 2010
Pre CRT 12 w post CRT
wait and follow upIncomplete response at 12 weeks
11 m 35 m Expand the Interval
local excision
radical surgery (TME)
From… MRI based (static process)
MDT decision on neoadjuvant treatment
Predefined surgery at 6-8 weeks interval
MRI plays pivotal role in defininga dynamic treatment process
- Upfront surgery
- Neoadjuvant chemo/radiation MR – response assessment
non-operative
cCR
resTumour specific Surgery
(flexible interval)
Call for centers of excellence in rectalcancer treatement
1. Complexity multidisciplinary decision making
2. Imaging, neoadjuvant treatment (none to TNT)
3. Complexity of minimally invasive TME surgery
Impact Hospital Volume (HV) and Surgeon Volume (SV) on QI in rectal cancer surgery
Hospital Volume Surgeon Volume
30 day mortality + +
Postopcomplications
+ -
Anastomotic leak + ++
LRR - +
5 yr survival - ++
J Gastrointest Oncol 2017; 8:534-546
Conclusion
The flexible transanal platform is the next step in MIS to rectal cancer
MR response assessment after neoadjuvant treatment first step in a dynamic process to define tailored surgical treatement
We should guide our patients through this dynamic process and take into account their preferences and expectations
Slide Number 1Slide Number 2Local recurrence: persistent problem�1984-1993 : 99 pts – low/mid rectal cancerTME - conceptSlide Number 5Slide Number 6Quality grading of surgeryTME implementation rsulted in a �significant decrease in APR rate in Belgium�(significant differences remain for distal rectal cancer))Rectal carcinoma�Actual treatment in rectal cancerSlide Number 11Slide Number 12Minimally Invasive surgery in evolutionCOLOR II trial (non-inferiority phase III) 2004-2010Slide Number 15Slide Number 16Slide Number 17Conversion to laparotomy�remains substantialCan robotics reduce conversions ?Primary endpoint – conversion to open surgery�becoming more proficient : CRM positivity (%) �Understanding the shortcomings of�laparoscopic TMESlide Number 23Slide Number 24Transanal Endoscopic Microsurgery( TEM)Slide Number 26Slide Number 27Transanal TME (taTME)Slide Number 29Slide Number 30Slide Number 31Slide Number 32Slide Number 33Slide Number 34Slide Number 35New technologiesSlide Number 37Slide Number 38Expanding the applicability of the platformSlide Number 40Slide Number 41The bulbar urethra ‘at risk’Understanding the operative force vectorsSlide Number 44Slide Number 45Slide Number 46Slide Number 47Slide Number 48Risk for a definitive stomaSlide Number 50Slide Number 51Slide Number 52Slide Number 53Slide Number 54Slide Number 55APE : optimizing surgical technique�“cylindrical APE”Slide Number 57Local recurrence after TaTME – 6 centres*Local recurrence after TaTME – 6 centres*Slide Number 60Slide Number 61Slide Number 62Slide Number 63Predicted risk for pCRM+Surgical decision making �in rectal cancer = complexMale patient: 75 yrs.�Moderate operative risk, ASA 2�well differentiated adenocarcinoma,juxta-anal (Rullier II) cT2 (3a) N?, M0�Slide Number 70Functional outcome and QoL after TME surgeryEarly, smallAdvanced tumorswait and follow upFrom… MRI based (static process) �MRI plays pivotal role in defining �a dynamic treatment processCall for centers of excellence in rectal cancer treatement�Impact Hospital Volume (HV) and Surgeon Volume (SV) �on QI in rectal cancer surgeryConclusion