COLORECTAL CANCER

State-of-the-art: Standard(s) of surgical practicefor resectable colorectal cancer (special issueson rectal cancer...)

Valencia, 17th May 2019

Carlos Vaz, M.D.Director of the Robotic Surgery UnitDirector of the Colorectal Cancer Unit and CUF Oncology Institute

VALENCIA, SPAIN

ESMO PRECEPTORSHIP

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Standards of surgical practice forresectable colorectal cancer

DISCLOSURE OF INTEREST

Consultant to Intuitive Surgical Inc.: clinical advisory & receiptof honoraria

Consultant to Cambridge Medical Robotics: clinical advisory & receipt of honoraria

Consultant to Medtronic: clinical advisory & receipt ofhonoraria

Standards of surgical practice forresectable colorectal cancer

COLON CANCER

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Standards of surgical practice forresectable colon cancer

- cT1 (?); NBI/chromoendoscopy – Kudo V- N0- < 30% of circumference- Histology grade 1 or 2- No linfovascular invasion- No perineural invasion

One piece (no fragmentation) AND Haggitt 1-3 pediculate or sm1 (invasion sm < 1000 µm) sessile AND Hist grade 1-2 AND No linfovascular invasion AND Margin - (≥ 1 mm)

EXCISED POLYP WITH ADC

ENDOSCOPIC LOCAL EXCISION: ESD (endoscopic submucosal dissection); if adc in pediculatedpolyp, consider EMR (endoscopic mucosal ressection)

All other cases, if resectable

COLECTOMY, WITH LINFADENECTOMY (≥ 12 LN);If available, laparoscopic or robotic; ?consider CME?

Standards of surgical practice forresectable colon cancer

COLECTOMY: OPEN VERSUS LAPAROSCOPIC

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Standards of surgical practice forresectable colon cancer

Lancet 2002; 359:2224-2229Laparoscopy-assisted colectomy versus open colectomyfor treatment of non-metastatic colon cancer: a randomised trial Antonio M Lacy, Juan C García-Valdecasas, Salvadora Delgado, Antoni Castells, Pilar Taurá, Josep M Piqué, Josep Visa

N = 442

Longer operative time

Reduced blood loss

Earlier recovery of bowel movements

Earlier tolerance to oral diet

Shorter LOS

Less complication rate: 12% lap - 31% open (wound infection / ileus / hernia)

Longer cancer related survival (recurrence 17% lap - 27% open)

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Standards of surgical practice forresectable colon cancer

Lancet 2002; 359:2224-2229Laparoscopy-assisted colectomy versus open colectomyfor treatment of non-metastatic colon cancer: a randomised trialAntonio M Lacy, Juan C García-Valdecasas, Salvadora Delgado, Antoni Castells, Pilar Taura, Josep M Piqué, JosepVisa

“There is evidence that surgical stress impairs immunity23,24 and that this feature is more intense in open surgery than in laparoscopic surgery.25,26 Immunity has a critical role in tumor progression and metastatic spread.27–29 This association could explain our findings…”

“In summary, our results show that LAC should be preferred to OC in patients withcolon cancer because it reduces perioperative morbidity, shortens hospital stay, andprolongs cancer-related survival. “

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Standards of surgical practice forresectable colon cancer

N Engl J Med 2004; 350:2050-2059A Comparison of Laparoscopically Assisted and Open Colectomy for ColonCancerThe Clinical Outcomes of Surgical Therapy Study GroupMulticentric / Mayo Clinic

“…decreased duration of hospitalization and decreased narcotic use…”

“Our findings suggest that it is safe to proceed with laparoscopically assistedcolectomy in patients with cancer.”

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Standards of surgical practice forresectable colon cancer

J Parenter Enter Nutr 2012; 36: 389-398Jonathan E. Rhoads Lecture 2011: Insulin Resistance and Enhanced RecoveryAfter Surgery (ERAS) Olle Ljungqvist

“... the surgical technique makes a major difference since laparoscopictechniques render minimal (insulin)resistance, whereas the same proceduredone using open techniques results in a 50% fall in sensitivity.”

“...insulin resistance is an independent predictor of length of stay. Along withthe type of surgery and blood loss during surgery, this parameter explains morethan 70% of the variation in length of stay.”

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Standards of surgical practice forresectable colon cancer

World J Surg 2013; 37:259–284Guidelines for Perioperative Care in Elective Colonic Surgery: EnhancedRecovery After Surgery (ERAS®) Society RecommendationsU. O. Gustafsson, M. J. Scott, W. Schwenk, N. Demartines, D. Roulin, N. Francis, C. E. McNaught, J. MacFie, A. S. Liberman, M. Soop, A. Hill, R. H. Kennedy, D. N. Lobo, K. Fearon, O. Ljungqvist

“Summary and recommendation: Laparoscopic surgery for colonic resections is recommended if the expertise is available.”

“Evidence level: Oncology: High.Morbidity: Low (inconsistency).Recovery/LOSH: Moderate (inconsistency).”

“Recommendation grade:Strong”

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Standards of surgical practice forresectable colon cancer

LAPAROSCOPIC RESSECTION FOR COLON CANCERProven to be better, even for oncological outcomes; should be recommended!

Standards of surgical practice forresectable colon cancer

COLECTOMY: LAPAROSCOPIC VERSUS ROBOTIC

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Standards of surgical practice forresectable colon cancer

Potential advantages for robotic approach

• Easier intracorporal anastomosis- ability to mobilize the bowel under vision without extending traction on the mesentery

especially in patients with a high body mass index- reduced manipulation of the bowel- smaller incisions- freedom to choose the extraction site

• Increase adoption of MI colorectal surgery among surgeons

• CME / Extended lymphadenectomy for right colon cancer

• Double use of ICG- guided lymphadenectomy- assessment bowel vascularization before anastomosis

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Standards of surgical practice forresectable colon cancer

We confirmed the clinical advantages of RRC with IA over LRC withEA in postoperative recovery outcomes and complication rate.

Furthermore, our preliminary analysis in a cohort of 30 TRRC shows promising results.

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Standards of surgical practice forresectable colon cancer

...in obese and other technically challenging patients, RIA facilitatesresection of a longer, consistent specimen with less mesenterytrauma that can be extracted through smaller incisions.

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Standards of surgical practice forresectable colon cancer

In conclusion, RRC and LRC are comparable in terms of functionalpostoperative outcomes and length of hospital stay.

RRC requires longer operative time, but the number of lymphnodes harvested may be higher.

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Standards of surgical practice forresectable colon cancer

Our results show that the majority of colectomies in the United States are still performed open...

The role of robotics is still being defined, in light of higher cost, lack of clinical benefit...

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Standards of surgical practice forresectable colon cancer

Minimally invasive approaches... lower mortality and morbiditycompared to an open...

...no significant difference in the morbidity between minimally invasiveapproaches, robotic surgery had a significantly lower conversion rate compared to laparoscopic approach.

Total hospital charges are significantly higher in robotic surgery...

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Standards of surgical practice forresectable colon cancer

...use of robot for right-sided CME is feasible and appears to provideremarkably a high number of harvested lymph nodes with goodspecimen quality.

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Standards of surgical practice forresectable colon cancer

Both approaches for right colectomy with CME were safe andfeasible and resulted in excellent survival.

Robotic assistance was beneficial for performing intracorporealanastomosis and dissection as evidenced by the lower conversionrates.

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Standards of surgical practice forresectable colon cancer

Robotic double ICG technique for robotic right hemicolectomy enables improved lymphadenectomy and warrants the extent of intestinal resection…

...thus, becoming a strong candidate for gold standard in robotic resections of the right colon for CRC.

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Standards of surgical practice forresectable colon cancer

In 11.2 % of the sample, the site of the anastomosis has been changed after ICG-test.

Moreover, when the ICG perfusion test has been performed no leakage occurred.

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Standards of surgical practice forresectable colon cancer

…a fluorescent mapping of draining lymph nodes, was visualized in all the 20 patients.

In 7 patients (35%), lymph nodes outside the standard lymphatic basin were identified and removed.

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Standards of surgical practice forresectable colon cancer

... comparable to lap... in terms of overall hospital charges andshort-term clinical outcomes, including length of stay andconversion rates...

...shorter learning curves and wider availability, robotic approachoffers a safe and economically feasible minimally invasive platformfor complex colorectal resections.

Standards of surgical practice forresectable colorectal cancer

RECTAL CANCER

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Standards of surgical practice forresectable rectal cancer

- cT1 (?); NBI/chromoendoscopy – Kudo V- N0- < 30% of circumference- Mobile (when reachable DRE)- Below peritoneal reflection (?)- Histology grade 1 or 2- No linfovascular invasion- No perineural invasion

One piece (no fragmentation) AND Haggitt 1-3 pediculate or sm1 (invasion sm < 1000 µm) sessile AND Hist grade 1-2 AND No linfovascular invasion AND Margin - (≥ 1 mm)

EXCISED POLYP WITH ADC

ENDOSCOPIC LOCAL EXCISION: ESD (endoscopic submucosal dissection); if adc in pediculatedpolyp, consider EMR (endoscopic mucosal ressection)

All other cases, if resectable

TME (≥ 12 LN, if no preop RT); upper 1/3 consider partial ME; lower 1/3 with sphincter or levator ani invasion, ELAPE;open, laparoscopic or robotic; taTME

Standards of surgical practice forresectable rectal cancer

TME: OPEN VERSUS LAPAROSCOPIC

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Standards of surgical practice forresectable rectal cancer

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Standards of surgical practice forresectable rectal cancer

Multicenter RCTsLaparoscopic vs. Open (rectal cancer)

1. MRC-CLASICC (UK)

2. COLOR II (International)

3. COREAN (Korea)

4. ALaCaRT (Australasian Laparoscopic Cancer Rectum Trial)

5. ACOSAG Z6051 (Am Coll Surg Oncology Group, USA)

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Standards of surgical practice forresectable rectal cancer

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Standards of surgical practice forresectable rectal cancer

Conversion rate 34% in rectal cancer subgroup

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Standards of surgical practice forresectable rectal cancer

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Standards of surgical practice forresectable rectal cancer

Disease-Free Survival in converted vs. open group

Worse both in colon cancer (HR 2.20, 1.31-3.67, p=0.007) and in rectal cancer (p=0.025)

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Standards of surgical practice forresectable rectal cancer

Lancet Oncology 2013 Mar;14(3):210-8

COLOR II Trial

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Standards of surgical practice forresectable rectal cancer

Bladder/sexual function was not reported in this short-term data paper.

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Standards of surgical practice forresectable rectal cancer

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Standards of surgical practice forresectable rectal cancer

Seoul National University & National Cancer Center, South Korea

COREAN Trial, Korea

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Standards of surgical practice forresectable rectal cancer

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Standards of surgical practice forresectable rectal cancer

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Standards of surgical practice forresectable rectal cancer

JAMA October 6, 2015 Volume 314, Number 13

ACOSOG Trial

Overall surgical success, measured by a nega- tive distal andcircumferential radial margin result and com- plete total mesorectalexcision, was higher in the open resec- tion arm (86.9%) vs laparoscopicresection arm (81.7%).

Conversion rate 11% in rectal cancer subgroup

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Standards of surgical practice forresectable rectal cancer

JAMA October 6, 2015 Volume 314, Number 13

ACOSOG Trial

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Standards of surgical practice forresectable rectal cancer

JAMA October 6, 2015 Volume 314, Number 13

ALaCaRT Trial

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Standards of surgical practice forresectable rectal cancer

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Standards of surgical practice forresectable rectal cancer

Bladder function worse in laparoscopic group

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Standards of surgical practice forresectable rectal cancer

Male sexual function worse in laparoscopic group

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Standards of surgical practice forresectable rectal cancer

Current Evidence on Rectal Cancer

1. Short-term benefits proven2. Mid- and long-term oncological equivalence not

inferior, but not strongly proven3. Bladder/sexual function still questionable4. Outcomes including survival worse in converted

patients

Summary: Laparoscopy vs. Open

Standards of surgical practice forresectable rectal cancer

TME: LAPAROSCOPIC VERSUS ROBOTIC

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Standards of surgical practice forresectable rectal cancer

WHAT IS ROBOTIC SURGERY?

Currently, “robotic surgery” could be described as:Video-endoscopic minimally invasive surgery using a non automated –master-slave - digital interface platform, interposed between the patientand the surgeon.

Current robotic surgery is an advanced form of minimally invasive video-endoscopic surgery.

The interposition of a digital interface between the patient and the surgeon opens a world of new possibilities and different perspectives.

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Standards of surgical practice forresectable rectal cancer

Robotic surgery concept: DIGITAL SURGERY

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Standards of surgical practice forresectable rectal cancer

Robotic surgery concept: DIGITAL SURGERY

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Standards of surgical practice forresectable rectal cancer

ROBOTIC SURGERYSELF-EVIDENT ADVANTAGES (OVER LAPAROSCOPY)

better visualization: high definition / 3D / 100% stable / surgeondriven

enhanced dexterity: the tip of the instruments (intuitively)replicates the human wrist motion (endowrist)

digital filtering of the natural shaking with increased precision

the relative location between the surgeon, the workspace, the fieldof vision and the surgical instruments - ergonomics – is potentiallyperfect

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Standards of surgical practice forresectable rectal cancer

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Standards of surgical practice forresectable rectal cancer

ROBOTIC SURGERYSELF-EVIDENT ADVANTAGES (OVER LAPAROSCOPY)

the arms of the robot move around a fixed point (pivot) at theabdominal wall, thus reducing the traumatic strain

surgeon directly controls three instruments

________________________

tissue dissection is easier, and anatomical planes clearer andbetter defined

manual sutures are easier, more accurate and safer

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Standards of surgical practice forresectable rectal cancer

ROBOTIC SURGERYADDITIONAL SELF-EVIDENT ADVANTAGES IN THE SUPER-OBESE

torqueing forces of the abdominal wall are overcomeby the strong robotic hardware

accuracy of control does not change with the lengthof the instruments and it’s always maximum

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Standards of surgical practice forresectable rectal cancer

Questions

1. What is the current evidence of laparoscopic rectal cancer resection?

2. What is the role of robotics beyond laparoscopy on rectal cancer surgery?

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Standards of surgical practice forresectable rectal cancer

Current Evidence on Rectal Cancer

1. Short-term benefits proven2. Mid- and long-term oncological equivalence not

inferior, but not strongly proven3. Bladder/sexual function still questionable4. Outcomes including survival worse in converted

patients

Summary: Laparoscopy vs. Open

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Standards of surgical practice forresectable rectal cancer

Q: ROBOTIC TME…

? Improves nerve function

? Decreases conversion

Ann Surg Oncol 2012;19:2095

Decreased conversion in robotic proctectomy

Early recovery of voiding/sexual function in robotic TME

Prospectively designed Lap TME (n=39) vs. Robotic TME (n=30) IPSS, IIEF score

Kim JY, et al. Ann Surg Oncol 2012;19:2485

“Early recovery of voiding function to normal level in robotic vs. laparoscopic group”

“Early recovery of sexual function to normal levelin robotic vs. laparoscopic group”

Better urinary/sexual function after robotic TME

• D’Annibale A. Surg Endos2013;27:1887

• Park SY, Surg Endos 2013;27:48

Dissection of the Anterior Rectum

Posterior to Denonvillier’s fascia Anterior to Denonvillier’s fascia

Video removed for web publishing Video removed for web publishing

ROBOTIC TME – anterior dissection

Video removed for web publishing

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Standards of surgical practice forresectable rectal cancer

Nova Medical School, 2nd May 2019

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Standards of surgical practice forresectable rectal cancer

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Standards of surgical practice forresectable rectal cancer

Systematic review: 2013 update

Obese Male Preoperative

radiotherapy Tumors in the lower 2/3

IMA high ligation with nerve preservation

Video removed for web publishing

Standards of surgical practice forresectable rectal cancer

taTME

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Standards of surgical practice forresectable rectal cancer

• Transanal TME has beenintroduced in 2010 to improvethe quality of TME procedurescompared to laparoscopicsurgery of rectal cancer

• Resection of mid and low rectal cancer remainschallenging due to the anatomy of the narrow pelvis

• Increased risk of recurrence

• Rectum is dissected transanally according to theTME principles

• Cohort series have demonstrated potentialbenefits of TaTME for rectal cancer:

• Low rate of involved circumferential resectionmargins, low morbidity rate

• High rate of sphincter saving procedures

• Single port surgery incl. a transanal and anabdominal port

• Considered as a new treatment (trend) andpotential benefits haven‘t been confirmed in aclinical trial yet

– COLOR III Trial study start May 2016• Transanal vs. Lap TME• Estimated Primary Completion

Date May 2020

• Described as an expert procedure with asteep learning curve

– High complication rate expected whenperformed without supervision

– Complications that have not beendocumented for the conventional lowanterior resection

• Urethra injury• Pelvic side wall injury with bleeding and

nerve damage

• Products used in procedure are differentto ones used in Lap TME

• Different anal port needed• Ideally need a longer Circular stapler• No Endocutter used for distal transection

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Standards of surgical practice forresectable rectal cancer

taTME Video | Sam Atallah, MD

Video removed for web publishing

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Standards of surgical practice forresectable rectal cancer

Standards of surgical practice forresectable rectal cancer

RECTAL CANCER OF THE LOWER THIRD:SPECIAL SITUATIONS

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Standards of surgical practice forresectable rectal cancer

T2 or T3 for ELAPE – consider W&W strategy

Possible low or ultralow (ISR) resection with anastomosis but functional anorectal preop workup shows bad function – consider permanent stoma

Any indication for ELAPE but patient refuses permanent stoma – try W&W strategy with or without local excision

Patient fully refuses permanent OR TEMPORARY stoma – accepts risk of non protected anastomosis? W&W strategy with or without local excision?

Standards of surgical practice forresectable colorectal cancer

THOUGHTS ON THE AVAILABLE EVIDENCE IN SURGERY...(learning from the past)

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Standards of surgical practice forresectable colorectal cancer

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Standards of surgical practice forresectable colorectal cancer

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Standards of surgical practice forresectable colorectal cancer

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Standards of surgical practice forresectable colorectal cancer

OBRIGADO.