Transanal Surgery for Large Rectal Polyps and Early Rectal Cancer

Transanal Surgery for Large Rectal Polyps and Early Rectal Cancer AB Harikrishnan Consultant Colorectal Surgeon, Sheffield Honorary Clinical Senior Lecturer, Sheffield University Associate TPD General Surgery, Yorkshire Deanery ACPGBI Yorkshire Chapter Representative

Clinicopathologic assessment What is it? TVA / HGD / T1 / T2 How does it look? Size, sessile, flat, stalk, residual scar from previous surgery or EMR Where is it? Rectum / rectosigmoid / peritoneal reflection Distance from anal verge Rectal folds Lateral orientation Circumference

Options Colonoscopic EMR / ESD Transanal Surgery Transanal excision (Parks) / TART TEMS / TEO TAMIS TASER RATS Radical surgery Contact radiotherapy Follow up

Surgery Transanal excision/tart Lower rectum < 5 cm from verge Posterior lesions full thickness excision Lloyd Davies, prone or lateral position Kit Parks anal retractor, diathermy Local infiltration to lift excise - direct closure of defect 1 cm margin Anterior lesions injury to vagina, prostate or urethra

Transanal excision limitations Views Retraction Distance from anal verge Transanal excision results

Options Colonoscopic EMR / ESD Transanal Surgery Transanal excision (Parks) / TART TEMS / TEO TAMIS TASER RATS Radical surgery Contact radiotherapy Follow up

Transanal Endoscopic Microsurgery - TEM Prof Gerhard Buess, Germany 1983 Proctoscope (fixed, beveled), camera, light source, working channels, suction irrigation (Richard Wolff) 180 deg -210 deg view Target lesion is inferior (lower) to working channels Patient position n=383, 4% recurrence, 10% complications (Buess, 1985)

TEMS World J Surg Proced. Mar 28, 2015; 5(1): 1-13

TEMS Van Vledder et al, Seminars in Colon and Rectal Surgery 26(2015)9 14

TEMS World J Surg Proced. Mar 28, 2015; 5(1): 1-13

TEMS and TEO

TEMS vs TA Excision Systematic review Moore et al, DCR 2008 55 case series + 3 comparative studies Negative margins 90% vs 71% Non-fragmented specimens 94% vs 65% Local recurrence 5% vs 27%

TEMS vs Transanal Excision SR and MA, Clancy et al, DCR 2015 6 comparative series, No RCT, n=927 Post op complications OR 1.018 p=0.937 Negative margins OR 5.281 p<0.001 Fragmented specimens OR 0.096 p<0.001 Local recurrence OR 0.248 p<0.001

TEMS and peritoneal perforation n= 481, 13 rectal cancers Perforation = 28 (5.8%) Conversion to abdominal procedure = 3/28 (10%) 2 lap, 1 open Morbidity 1/28 (3.8%) rectovesical fistula - APER Mortality Nil Perforation group Longer op time (120 vs 60 min) p<0.001 Longer hospital stay (6 vs 4 days) p=0.003 Multivariate analysis distance from verge >7cm (p=0.010) Overall survival/distant mets no difference Morino et al. Surg Endosc (2013) 27:181 188

TEMS and anorectal function Resting and squeeze pressures fall in first 3 months Return to baseline in 6 12 months Rectal sensitivity thresholds reduced at 3 months Urgency Increase Wexner score Return to normal in 1 year QOL scores at 1 year and 5 years are high Longterm QOL scores are better than TME group Allaix et al. Surg Endosc (2016) 30:4841 4852

TEMS vs radical resection T1/T2 n=942, 10 trials, TEMS 445, RR 438 systematic review and meta-analysis TEMS RR OR Local recurrence 48 13 2.78 Overall recurrence 62 31 2.01 Distant recurrence 14 16 0.87 Overall survival 190 193 0.80 Mortality 14 17 0.7 TEMS shorter op time & LoS, reduced complications Sajid et al. Colorectal Dis. 2014 Jan;16(1):2-14.

TEMS vs ESD SR and MA n=2077, 11 ESD and 10 TEM series ESD TEM En bloc resection rate * 88% 99% R0 resection rate * 75% 88% Complication rate 8% 8% Recurrence rate * 2.6% 5.2% Post trt abd resection rate * 8.4% 1.8% The ESD procedure appears to be a safe technique, but TEM achieves a higher R0 resection rate when performed in full-thickness fashion, significantly reducing the need for further abdominal treatment. Arezzo et al. Surg Endosc (2014) 28:427 438

Recurrence after TEMS Restage and reassess the patient Locoregional / distant Redo TEMS benign, HGD, fitness Malignant lesion Anterior resection / APER/ TaTME Ext Radiotherapy locoregional control Contact radiotherapy Distant disease Chemotherapy

TEMS Complications Operative mortality <1% Major complications <2% Rectal wound dehiscence Bleeding reactionary and delayed Rectal pain Perirectal abscess and fistula Rectovaginal fistula Rectal stricture Minor complications <10% Urinary retention Mucus discharge Minor bleeding Functional outcomes QOL preserved at 1 year and 5 years QOL and sexual function impaired for post RTX group

TEMS for rectal Ca new perspectives Lymph node staging Endoscopic posterior mesorectal excision (EPMR). Tarantino et al, 2008. Safe, low morbidity, comparable oncological data! Sentinel lymph node biopsy NTEMS nucleotide guided TEMS and LN sampling. Lezoche et al, 2013. Indocyanine Green (ICG) / near IR camera sampling. Arezzo et al, 2014. Predictive biomarkers Chromosome 8q23-24 gain = marker for LN +ve. Ghadimi et al, 2003. Chromosomal copy number. Chen et al, 2013. PROGRESSS perirectal oncologic gateway for RP endoscopic single-site surgery. Leroy et al 2013. Robotic assisted transanal surgery (RATS). Atallah et al, 2015.

Early Rectal Cancer other treatment options Selective post op radiotherapy Neoadjuvant radiotherapy followed by TEM Neoadjuvant chemorad followed by TEM Rectal wound complications are high Oncological outcome similar to standard resection Functional outcomes are poor Trials

Trials TREC T1-2N0 TME/APER vs SCRT + TEMS STAR-TREC T1-3bN0 TME vs SCRT/CRT followed by w&w or TEMS TESAR T1-2, medium risk Post TEMS Adjuvant chemorad vs TME TREND Large rectal adenomas TEMS vs EMR CARTS Neoadjuvant long course chemorad followed by TEMS

Options Colonoscopic EMR / ESD Transanal Surgery Transanal excision (Parks) / TART TEMS / TEO TAMIS TASER RATS Radical surgery Contact radiotherapy Follow up

Trans Anal Minimally Invasive Surgery (TAMIS) Atallah et al, Surg Endo 2010 Single-incision, multiport device Laparoscopic instruments and energy source Laparoscopic surgical skills parallel choreography Applied to transanal surgery FDA approval GelPOINT Path (Applied Medical) SILS Port (Medtronic)

GelPOINT Path and SILS

TAMIS vs TEMS TAMIS TEMS/TEO Low profile shorter platform 3 mins Flexible set up Easy movement to all quadrants Non-proprietary insufflator Bellowing and fogging Low and mid rectal lesions Not for very low lesions Rigid elongated platform Up to 20 mins Rigid fixed set up Fixed to one quadrant Dedicated insufflator More stable pressure Higher lesions up to 25 cm Lower rectal lesions possible

TEMS vs TAMIS Transferable skills Complementary approaches Cost effective to choose one Foundation for other procedures TaTME SILS TASER

TEMS vs TAMIS Lee et al, DCR, 2017 Multi-institutional matched analysis (2 TEMS vs 1 TAMIS) n=428 (247 TEMS, 181 TAMIS) Full thickness excisions only Poor quality specimen(margin/frag) 8% vs 11% p=0.233 Peritoneal violation 3% vs 3% p=0.965 Post op complications 11% vs 9% p=0.477 Local recurrence 7% vs 7% p=0.864 Cum 5-yr survival 80% vs 78% p=0.824 TAMIS shorter operative time and LOS

Risk of residual disease Depth of invasion Differentiation Lymph node involvement Resection margins Lymphovascular invasion

ACPGBI Risk Stratification Risk Factor Score Margin <1mm ++++ Margin 1-2mm + Pedunculated Haggitt 4 ++++ Sessile Kukuchi 2 ++ Sessile Kukuchi 3 ++++ Poor Differentiation +++ Mucinous tumour + Tumour budding + L/V invasion ++ Williams et al. Colorectal Dis. 2013 Aug;15 Suppl 2:1-38.

ACPGBI Risk Stratification Total Score Grade Estimated Risk Action 0 Very low <3% Routine follow up + Low <5% Careful follow up ++ Medium 5-10% Discuss risk / benefit of surgery or follow up +++ High 8-15% Discuss towards surgery ++++ Very high >20% Recommend surgery unless unfit Williams et al. Colorectal Dis. 2013 Aug;15 Suppl 2:1-38.

Plan The lesion The patient Fitness, co-morbidity, preference The unit

Balancing the risk of surgery R0 Primary lesion Nodal clearance Morbidity Mortality of Surgery