Early rectal cancer: I can do it better · T1b vs. 1a EUS best modality LN+ EUS-FNA + CT/MR (DWI)...

Reiner Wiest

UVCM, Inselspital Bern

Early rectal cancer:

I can do it better

SGVC 2018

Inselspital Bern: UVCM – Klinik für Viszerale Chirurgie und Medizin

Fair duellation ?

One endoscope

One working channel

„single arm bandit“

SGVC 2018

The endoscopists weapon...............

Near Focus Retro-

flexion

NBImagnification

SGVC 2018

Endoscopic submucosal dissection

80 x70 mm

Tubulovillous Adenoma

En-bloc

R0-resection

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Better in terms of

Safety: morbidity and mortality

Oncological outcome

Quality of life

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Cost - advantages for ESD

No operation theatre

No general anaesthesia

.........

cases Procedure Time

ESD/ TEM

Hospitalisation

ESD/TEM

Park et al 30/33 84+/-51 116+7-58 3.6+/-1.2 4.8+/-3.3

Kawaguti et al 11/13 133+/-60 150+/-66 3.8+/-3.3 4.0+/-1.7

Jung et al. 48/ 23 n.s. 2.3+/-1.2 5.8+/-1.8

....................

Park et al. Endoscopy 2011; Kawaguti et al. Surg Endosc. 2014; Jung et al Surg Endo 2014

SGVC 2018

no lymph-invasion

no (only low grade) budding

< 1000 mikrometer invasion

Oncological approach – outcome in ESD

No need for oncological full thickness resection

when no risk factor for LN-positivity

(in absence of poor differentiation)

Do you know this before intervention ?

diagnostic accuracy pre-operatively by

chromoendoscopy, near-focus, high-definition, EUS...

is suboptimal

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is the best

DIAGNOSTIC MEASURE

Avoiding overtreatment

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Endoscopic resection does not decrease outcome

after subsequent surgery

Overwater, Gut 2017

602 pts. (263 primary vs. 339 secondary surgery)

34 recurrences (5.9%)

No differences in

Presence lymph-node positivity (OR 0.97) 0.49-1.43

Recurrence (HR 0.97) 0.41-2.34

Endoscopic En-bloc resection

of a possible T1 CRC without evident signs of deep invasion

justified

in order to prevent surgery of low-risk T1 CRC

in a significant proportion of patients

SGVC 2018

Selection of early rectal cancer for endoscopic resection

Risk of deep sm-invasion

Homogenous

No NBI-risk-

features

> 30%With NBI-

risk features

+ depressedNo

Lateral Spreading Tumor (LST)

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NBI-magnification: classification- systemsS

lassif

Sensitivity > 70% with Specificity > 90%

e.g. Typ 3 b / Typ C2

rather no candidate for ESD

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Endoscopic full thickness resection (FTRD)

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15 mm T1sm1-L0V0G2- R0

Endoscopic full thickness resection (FTRD)

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Comparison of resection techniques

ESD vs. Surgical Methods

(no randomized trial, no meta-analysis)

Backes, Am J Gastroenterol 2017, Lee, Ann Surg 2017, Kiriyami Endoscopy 2011, SaitohDig Endoscopy 2016, Kim DigDisSci 2015, Higuti Jpn Soc Coloproct 2006

ESD TEM/TAMIS

Local Recurrence 0 - 3.4% 1-6%

Quality pathology

specimen

(fragmentation 5%)

Complication rate + ++

SGVC 2018

Safety: ESD vs. surgical approach

Complication rate

ESD TEM/TAMIS

Jung et al. 4.3+/-1.2 5.8+/-1.8

Arezzo et al. 8.0+/-2.2 8.4%+/- 4.2

Clancy et al. 3.3+/-1.3 6.9+/-3.2

..............

truely minimal invasive

organ preserving

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Quality of life - advantages for ESD

62 ESD vs. 32 LAC in T1 rectal cancer

Questionaires for quality of life POD1 and POD 14

POD1POD14

Nakamura et al. DigDis2017

ESD achieves excellent results

in quality of life after local resection

in early rectal cancer

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GII 2013

T2N1M0

Neoadjuvante RCTx

Refusal for

oncological surgey

Combining techniques: ESD plus TAE

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Combining TAE and ESD

Yang et al. GII 2013

T1a/m1 L0V0G2

T1-sm2 -L0V0G2

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Endoscopic TAMISMcLemore et al. Gastroenterology 2013

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SUMMARY: endoscopic approach for rectal neoplasia

easy access, wide/ great visibiliy/resolution

best diagnostic measure

truely minimal invasive

keeping quality of life optimal

preserving organ + functionality

Low in cost

is the WINNER

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ADD ON ADD ON ADD ON

SGVC 2018

Complication rates

ESDTEM TAMIS

Depends on comorbidities, age, medication....

SGVC 2018

Which lesions benefit most? ESD better suited for ?

• SM1, no lymphovascular invasion, no budding

Fuccio L, Gut (Online First 2018)

Reaching to anocutan line

Large surface area (e.g. > semicircular

More superficial (Tis, T1a) where

no full thickness is oncologically

SGVC 2018

How accurate pre-operative prediction of risk

factors

Increased risk of deep submucosal infiltration:

- irregular surface/ non-granular LST

- depressed or pseudo-depressed morphology

Then full-thickness not needed !!

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Endoscopic resection does not decrease outcome

after subsequent surgery

Overwater, Gut 2017

-> attempt for an en-bloc resection of a possible T1 CRC without

evident signs of deep invasion seems justified in order to

prevent surgery of low-risk T1 CRC in a significant

proportion of patients.

SGVC 2018

-> attempt for an en-bloc resection of a possible T1 CRC without

evident signs of deep invasion seems justified in order to

prevent surgery of low-risk T1 CRC in a significant

proportion of patients.

SGVC 2018

Reliable assessment of depth of invasion

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1 : 100

• 1 ESD expert enough to resect rectal lesions discovered by

100 endoscopist performing screening colonoscopies all

SGVC 2018

Risk of LN – in dependency on sm-invasion

0-3% 8-10% 23-25%

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EUS most accurate method

To differentiate T1 from T2

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Higher LN-risk

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Risk LN pos

Granular > Non-granular

Risk LN pos in Non-granular

With nodule and/or depressed > without nodule

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FTRD when sm-positivity suspected......

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cases En-bloc

ESD/TEM

Recurrence-

Park 30/33 97%/ 100% 97%/ 97%

Kawaguti 11/13 82%/ 84% 82%/ 84%

Verra 89%/ 99% 74%/ 89%

Arezzo 87%/ 98% 75%/ 88% 2.6%/5.2%

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p-EMR ESD TEM/TAMIS

Local Recurrence 3.4 %

10-23.5%

0-3% 6%

Quality of the

pathology

specimen

--- +++ + (7% R1, 5%

fragmentation)

Impact on rescue

surgery

0 0 ---

if full thickness

resection

Duration of

procedure

+ +++ ++

Cost + ++ +++

Complication rate + ++ +++

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ESD advantages and strength

- Best diagnostic/staging procedure

- Surgical approach in case being non-curative not hampered

- Organ-anatomy-function sparing

- Better patient quality of life

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...procedure needs to be....

SAFEno

perforationno

major bleeding

HIGH QUALITYR0 en-bloc

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ESD: What do Limits depend on ?

Expertise

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ESD: Who is an Expert ?

Naohisha Yahagi Reiner Wiest= EXPERT

Pioneer in ESD

Inventor of Dual-Knife

ESD > 12 years

Daily ESD, difficult cases

> 500/year

Training the trainer

SGVC 2018

Duodenum: most challenging-> rarely ESD done (except Experts) large lesion in bulb

45×30mm, adenocarcinoma tub1,

T1a(M),Ly0,v0,HM0,VM0Courtesy Prof. N. Yahagi

Tokio, Keioto University

SGVC 2018

Esophagus: circumferential extensive ESD

in Barrett C11M12 with multi-level HGD + carcinoma

14 cm long resected specimen incl. adenocarcinoma

T1a(M),Ly0,v0,HM0,VM0 Wiest R, Caca K et al

SGG 2017

SGVC 2018

Size/Area cm2

Location

Pre-treatment:

Fibrosis..............

Lesion-Limits for ESD ?

For Expert

Really

limiting

Can be

difficult/

limiting

SGVC 2018

less time consuming to learn: easy and safe

CE-market currently for lower GI tract

Full thickness resection device (FTRD)

Limits: lesion size = cap length 23 mm

Subepithelial Tumors (rather/more diagnostic)

Pre-treated pre/- early malignant lesions

SGVC 2018

....procedure needs to make....

SGVC 2018

ESD and Full-thickness only

make sense in case of

only then local resection is curative

Absence of lymphangio-invasion

No lymph node positivity

SGVC 2018

„Expanded“ criteria for ESD in stomach

Equal to „normal“ guideline indications for

overall survival, recurrence-rate

Gotoda et al. Gastric Cancer 2000; Br J Surg 2010

Oncological Limits for Gastric ESD

SGVC 2018

Hölscher A et al. Ann Surg 2009

Rate of LN-positivity in early gastric cancer

Diagnostic accuracy

T1b vs. 1a EUS best modality

LN+ EUS-FNA + CT/MR (DWI)

NPV suboptimal

(55 - 90 %)

SGVC 2018

Endoscopic full-thickness resection + sentinel LN-navigation

+ laparoscopic closure

Hybrid: endoscopic AND laparoscopic approach

Kim et al. ClinEndos 2017

Optimized T- and N- staging

= best oncological decision making

= treatment = prognosis ?

SGVC 2018

SERVICE

Worth Pushing Limits

training-> expertise-> ESD/FTR are

feasable for most early cancer lesions in upper GI tract

Main limitation pre-operative accuracy for LV/LN+

combined endoscopic + laparascopic + sentinel LN-dissection

Limitations or Triple-S

for ESD/full thickness resection

SGVC 2018

„Once you accept your limits

you go beyond them“

Albert Einstein

SGVC 2018

Park JY, Kim YW, Ryu KW, et al. Assessment of

laparoscopic stomach preserving surgery with

sentinel basin dissection versus standard

gastrectomy with lymphadenectomy in early

gastric cancer-a multicenter randomized phase

III clinical trial (SENORITA trial) protocol. BMC

Cancer 2016;16:340.

SGVC 2018

Ahn et al. GIE 2011

Extended criteria for gastric ESD

SGVC 2018

ESD success in dependency on size and location

75% of the circumference

independent risk factor for perforation

(OR = 7.37, 95%CI: 1.45-37.4, P = 0.016)

Noguchi M et al. WJG 2017

Lesion size < 49 mm > 50 mm

En-bloc-rate 89.4% 85.7%

R0-rate 70.8% 40.5%

Proc. time/min 92+62 217+120

Complications 9.2% 17.6%

Dumoulin et al. Endoscopy Int Open 2016

SGVC 2018

Limitations or Triple-S

for ESD/full thickness resection

SERVICE

Worth Pushing Limits

training-> expertise-> ESD/FTR are

feasable for most early cancer lesions in upper GI tract

Main limitation pre-operative accuracy for LV/LN+

combined endoscopic + laparascopic + sentinel LN-dissection

SGVC 2018

Summary - Outlook

needs to be safe

expertise of the operateur is most important

training is essential and quality criteria needed

soon routine and „easy“ to use

Oncological strategy / diagnostic accuracy

and patient-oriented

SGVC 2018

Triple S-

Surgical candidates:

Consider ESD/FTRD as diagnostic tool

Inoperable patients:

Individual decision

After optimal diagnostic workup

SGVC 2018

Diagnostic accuracy

T1b vs. 1a EUS best modality

LN+ EUS-FNA + CT/MR (DWI)

NPV suboptimal

(< 90 %)

SGVC 2018

Cases/Erfahrung 1-24 25-50 >50

En-bloc-rate 60% 88% 96%

R0-rate 48% 76% 84.5%

Perforationen 1.3% - -

Probst et al. Endoscopy 2012

ESD: complication rate and training

SGVC 2018

What do Limits for ESD depend on- else ?

Patient: condition, medication, fitness, wishes

Local infrastructure: assistance

Case-Load of center

SGVC 2018

Water Pressure Method

Yahagi N et al. Endoscopy. 2017

ST hoodFuji film medical ,

Traction

Method

Device

Patient

Position

SGVC 2018

Full thickness resection device (FTRD)

SGVC 2018

Oncological Limits for ESD

Pre-Operative diagnostic accuracy ?

Aim of treatment ?

Risk of LN-Positivity in dependency on infiltration depth

SGVC 2018

Oncological Indication for Esophageal ESD

Squamous Ca

mucosal cancer

Adeno/Barrett Ca

mucosal cancer

< 100 mm

SGVC 2018

Morbidity and Mortality from surgery ?

1-4 % dependend on patient, location, tumor....

SGVC 2018

Quality criteria ESD

Histology for specimen

Lateral and vertical margin!

Desmin-staining for L.musc.mucosa->

From here on grading sm since > 500 mikrometer in

Victoria blue (or D2-40-staining) better vascular invasion

SGVC 2018

PULS of gastric ESD

Non-curative ESD – Definition - consequences

Positive vertical margin

Undifferentiated grading

Lymphangioinvasion

Sm-positivity (> sm 1)

High risk of recurrence and/or LN-positivity

Gastrectomy with LN-dissection

Deep margin

Predicts 10y

T1 EAC-Barrett

Leggett et al. ClinGastroHepatol

SGVC 2018

344 ESD for early gastric cancer

43 patients operated due to:

residual mucosal cancer (R1)

Mucosal cancer larger than 3 cm

submucosal cancer

regardless of size or margin

When is ESD for early gastric cancer curative ?

Ryu et al. Annals Surg Oncol 2007

< 500 mm sm invasion

< 30 mm size

NO (0/39)

SGVC 2018

ESD for undifferentiated early gastric cancer ?

Abe et al. Endoscopy 2013

SGVC 2018

Sentinel-lymph-node stratetgy to optimize

Oncological accuracy when aiming for curation

NPV 67-94%

Meta-Analysis

B. Filip et al. SurgEndosc 2014

At best combination radioactive colloid (e.g. 99Tc)

dye (e.g. ICG)

NPV 90%

Meta-Analysis

Wang et al. Ann Surg Oncol 2012

SGVC 2018

Goto, Yahagi et al. Transl Gastro Hepatol 2016; Cho et al. Endoscopy 2011

Endoscopic full-thickness resection + sentinel LN-navigation

+ laparoscopic closure and

SGVC 2018

GERDx System; G-SURG

GmbH, Seeon-Seebruck,

Germany

SGVC 2018

ESD: Traction-method

SGVC 2018

Endolifter (Olympus, Tokyo)

SGVC 2018

Together

Combined

Laparoscopic plus endoscopic

NEWS procedure

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expanded criteria von Gotoda gelten in Japan als Standard und sind auch mit

überlebensdaten validiert, d.h. Schneiden wirklich gut ab und sind allgemein (auch im westen

zentren) anerkannt. En-bloc resektion in den grösseren Serien (aus Japan) oft und

meist der einzige prädiktive Faktor für langfristige nachhaltige Kuration, dh. Dann exzellente

Langzeitprognose (z.b. Isomoto H Gut 2009; 58; 331ff). Dies spricht eben wiederum klar für

risiko sicher entscheidend und meines wissens die Literatur kontrovers: z.b. Von Hölscher

AH et al. Ann SUrg 2009, 250:791 auch bei T1-m3 Tumoren LK-positivität berichtet (nach

Gastrektomie mit Lymphadenektomie)! Dagegen bei m1/2 nie und auch alle mukosalen

Karzinome < 2 cm alle ohne LK-positivität (wobei die Arbeit leider keinen L-status im

Präparat angibt, wahnsinn). Interessant in dem Zusammenhang der Ansatz der Asiaten: nach

ESD bei Hochrisiko-features für LK-positivität laparoskopisch eine Lymphadenektomie

machen und falls eben L0 dem Patienten die Gastrektomie zu ersparen mit vielversprechendne

Daten (die zwar aus 2010 sind z.b. Kim YH et al. Korean J Gastrointest. Endosc. 2010:

96) hab aber nichts neues mehr gesehen); erscheint mir aber (als nicht -chirurg) ein

SGVC 2018

Basically (very low or) NO risk of LN-postivity when

G1 or papillary histopathology

M1 or m2 depth and < 2 cm

Sm1 but < 1 cm

SGVC 2018

role of tumor type

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role of tumor size

Risk of LN+ starts already in m3- tumors

Particularly if

> 20 mm in size

SGVC 2018

ESD: Case Load in Germany - Expert-Hands ?

New Suturing Technique Using Clip and Line

Yahagi N et al. GIE 2016 , Nishizawa T, Yahagi N et al. GIE 2017

SGVC 2018

Large Duodenal Lesion Located at 2nd Portion

SGVC 2018

7 months after

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Fullthickness upper GI-tract

Device - method

SGVC 2018

Duodenal Adenoma + Malignancy: Chromoendoscopy

SGVC 2018

Tubular adenocarcinoma in adenoma

0-Ⅱa, 57×42mm, tub1>>tub2

pTis, ly0, v0, pHM0, pVM0

SGVC 2018

Naohisha Reiner

What do Limits

for ESD/FTRD depend on ?

Expertise/Training

Equipment

Local Setup

Limit ?

very individual

SGVC 2018

ESD better than EMR

Size: unlimited in area

(vs. Snare-size for EMR)

Depth: highly controlled up to full sub-mukosa

(vs. Uncontrolled in EMR)

higher rate of

en-bloc, R0, local-recurrence

Meta-Analyse Lian J GIE 2012

SGVC 2018

Indikationen FTRD Colon

SGVC 2018

Gastric polyps:

Which are not mucosal ?

Diagnostic accuracy – Gastric

EUS: T1/2 vs. T3/4: sens 86%, spez 91%

N-positivity: sens 69%, spez 84%

Mocellin S et al. GIE 2011

Early rectal cancer: I can do it better · T1b vs. 1a EUS best modality LN+ EUS-FNA + CT/MR (DWI)...

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