PRO-CONTRO PRO-CONTRO Trattamento delle lesioni mucose estese del colon: resezione piecemeal o ESD? Federico Buffoli, Federico Iacopini PRO-CONTRO Trattamento delle lesioni mucose estese del colon: resezione piecemeal o en-bloc? EMR o ESD Federico Buffoli, Federico Iacopini • terminologia • tecniche miste PRO-CONTRO www.apartystyle.com EMR o ESD Federico Buffoli, Federico Iacopini PRO-CONTRO Federico Buffoli, Federico Iacopini Trattamento delle lesioni mucose estese del colon come trattare • superficial neoplastic lesions Trattamento delle lesioni mucose estese del colon resezione endoscopica • Intento curativo • Conservazione della funzionalità • Precisa valutazione istologica • Variabili che condizionano la modalità di resezione: Dimensioni Morfologia Rischio di infiltrazione neoplastica (T1) piecemeal vs en-bloc Trattamento delle lesioni mucose estese del colon resezione curativa per EMR piecemeal • margini laterali verticali liberi da neoplasia Rischio di einfiltrazione neoplastica (T1) • infiltrazione sottomucosa assente • Resezione endoscopicamente completa in macroframmeti orientati che contengano ognuno parte della sottomucosa Curative Endo Resection of sup. CRC Cure = complete removal of the 1. Primary Tumor 2. Metastasis Indication for Surgery = balance between 1. Metastasis risk 2. Surgical risk 3. Expected QoL after resection ESD Curative Resection: definition En bloc R0 Margins lat. & vert. Neg Curative SM+ Grading Ly/v Budding <1000 µm (sm-slight) G1 - G2 Neg 1 Curative Endoscopic Resection JSCCR guidelines 2010. Watanabe T. Int J Clin Oncol 2012 LOW <1% HIGH-risk 6-14% of LN metastasis LN metastasis Risk of sup. CRC Lesion Morphology Pedunculated Non pedunculated SM invasion depth other SM 0 (Haggitt 1,2: head) ly NEG 0 SM + (<3000 mm) ly NEG 0 SM + (Haggitt >2) ly POS 14-44 SM + SM-s (<1000 mm) n. LN+ (%) 724 11 ly / v NEG Grading 1-2 Budding 1 0 SM-d (>1000 mm) Kikuchi R. DRC 1995 Katajima K. Study. J Gastroenterol 2004 Bosch SL. Systematic review. Endoscopy 2013 11-15 ly + v+ Grading 3 Budding 2-3 5 x2 x5 x5 x Curative Resection of sup. CRC EMR - piecemeal ESD - en bloc ≠ Trattamento delle lesioni mucose estese del colon en-bloc dati di prevalenza piecemeal vs dimensioni del problema Trattamento delle lesioni mucose estese del colon dati di prevalenza • polypoid …………………… 61.1 % • nonpolyp. & nondepressed 36.4 % (slightly elevated or completely flat) • nonpolipoyd depressed…. 2.4 % GASTROINTESTINAL ENDOSCOPY Volume 68, No. 4 : 2008 Trattamento delle lesioni mucose estese del colon dati di prevalenza dimensions and s.m. ca % s.m. ca in 38673 lesions § ~5mm 6-10mm 11-19mm >20mm • polypoid …………………… 1.7- 2.4% 0-0.07% 1.3- 1.6% 5.8 -10.3% 14.0-29.1% • nonpolyp. & nondepressed 1.3- 2.1% 0-0.03% 0.3- 1.7% 5.3- 5.4% 7.4-19.5% (slightly elevated or completely flat) • nonpolipoyd depressed…. 27.0-35.9% 6.0-8.4% 17.7-43.6% 53.4-73.2% 80.0-87.0% GASTROINTESTINAL ENDOSCOPY Volume 68, No. 4 : 2008 • 2013 Trattamento delle lesioni mucose estese del colon dati di prevalenza • Lesioni rimosse 1100 n° T1 % • Ø ≤ 5 mm 498 1 0.20 • 5< Ø ≤20 mm 520 7 1.35 82 6 7.32 • > 20 mm 8% Trattamento delle lesioni mucose estese del colon invasive cancer risk 0.0% 2.7% 2.8% 33.7% 91.5% • III L • III S • IV • Vi • Vn non neoplastic pattern • I • II GASTROINTESTINAL ENDOSCOPY Volume 68, No. 4 : 2008 • 2013 Trattamento delle lesioni mucose estese del colon dati di prevalenza Vi, Vn • totale 15/1100 = 1.4% • Ø ≤ 5 mm 1/ 498 = 0.2% • 5< Ø ≤20 mm 3/ 520 = 0.6% • > 20 mm 11/ 82 = 13.4% • > 20 mm non ped 8/ 68 = 11.7% piecemeal vs en-bloc F. Buffoli Trattamento delle lesioni mucose estese del colon • … pit pattern diagnosis based on magnifying endoscopy is very useful for deciding upon indications for ESD or for piecemeal EMR. piecemeal vs en-bloc Lesion Risk Staging 1. Diagnostic yield of preop staging modalities 2. Strenght of data on neoplastic risk of sup. CR neoplasms 3. Pragmatism of Japanese guidelines Endo Staging of SM+ depth Sens Spec Saitoh Y. GIE 1998 CE Endo macro 97 70 Hurlstone DP. Colorectal Dis 2004 Magnif -CE Pit Vi vs Vn 97 50 Bianco MA. Endoscopy 2006 Magnif –CE Pit V 79 98 Matsuda T. AJG 2008 Magnif –CE Clin invasive pattern 87 99 Fu KI. Dig Dis Sci 2008 Magnif –CE Pit V 88 89 Kanao H. GIE 2009 Magnif –NBI Type C (Hiroshima) 100 79 Oba S. SJG 2010 Magnif –NBI Type C (Hiroshima) 90 50 85 89 Ikematsu H. BMC Gastro 2010 Magnification Magnif –NBI Type III (Sano) Haruki S. Gastroenterol Res Pract 2012 Magnif –CE Pit Vi vs Vn 79 83 Shimura T. CGH 2013 Magnif –CE Clin invasive pattern 74 69 Kudo SE. J Gastroenterol Hepatol 2014 M-CE + Cytoscopy Pit Vi vs Vn 83 99 Kudo SE. J Gastroenterol Hepatol 2014 Magnif –CE Pit Vi vs Vn 75 98 Endo Staging: histology type low vs high Magnification good Higashi R. GIE 2010 Endo Staging of SM+ depth impact of Lesion Morphology 0-I 0-IIa 0-IIc SM deep 76% (75/79) 86% (6/7) 99% (73/74) Adenoma M-ca SM superf 99% (2676/2691) 100% 1257/1260 93% (78/84) Matsuda T. AJG 2008 Endo Staging interobserver agreement SM+ depth Lesion histology 2 expert Japanese endoscopists Single center M-CE M-NBI op1 Op2 op1 op2 Sens 61 83 61 78 Spec 94 74 94 78 Accuracy 83 76 83 79 K value 0.63 Substantial 0.44 moderate what tech K value Huang Q. GIE 2004 pit CE 0.78 Lee CK. GIE 2011 pit vasc NBI iSCAN >0.6 Masci E. DLD 2013 pit Vasc iSCAN 0.45 8 italian experts - multicenter Sakamoto T. Dig Endosc 2011 Epidemiology: SM+ in LST relevance of Morphology + Size Uraoka T. Gut 2006 Oka S. Dig Endosc 2009 Saito Y. Dig Endosc 2009 Hiroshima University NCCH Tokyo Strategy for sup. CR neoplasms JSCCR guidelines 2010 Tanaka S. Dig Endosc 2013 Trattamento delle lesioni mucose estese del colon Tecnica EPMR • Praticabile in oltre il 95% delle lesioni colorettali • Non necessita di device dedicati vs ESD • Indicata in meno del 5% delle lesioni colorettali • necessita di device dedicati e costosi • Tecnicamente “facile” • Tecnicamente complessa • Tempi di esecuzione • Tempi di esecuzione relativamente brevi • Basso rischio di complicanze relativamente lunghi • Alto rischio di complicanze Trattamento delle lesioni mucose estese del colon Modello giapponese di trainig strutturato per ESD Proposta di training per endoscopisti occidentali Trattamento delle lesioni mucose estese del colon perforazione F. Buffoli Trattamento delle lesioni mucose estese del colon perforazione perforazione Trattamento delle lesioni mucose estese del colon Gastric ESD is a standard in the West ESD Feasibility c-ESD is a Standard in Japan JSCCR guidelines 2010 Colorectal ESD was approved for health insurance coverage in April 2012 CRC incidence (2008) According to the literature survey, the safety and efficacy of colorectal ESD has been established c-ESD outcomes East vs. West n. Size (mm) En bloc (%) Recurrence (%) Perforation (%) JAPAN (Saito Y. GIE 2010) 1111 35 88 1 5 EUROPE (up to 2013) 389 37 71 8 9 Hurlstone 2007 42 24 79 11 2 Hurlstone 2008 30 12 41 10 0 Coda 2010 14 25 79 7 29 Azzolini 2011 11 35 45 9 9 Hulagu 2011 25 86 90 4 8 Farhat 2011 (multicenter) 85 32 67 n.a. 18 Probst 2012 82 46 82 10 8 Iacopini 2012 60 30 68 2 5 Repici 2013 40 47 90 0 3 Training Cimabue Giotto 1277 1304 S.Francesco, Assisi Cappella degli Scrovegni, Padova 50th ESD (Nov 2011) Ascending C LST-G H 1st ESD (June 2008) Gastric antrum Type IIc, U- 20 mm T1(sm1), G1, v/ly Op.Time: 240 min 80 mm T1(sm1), G1, v/lyOp.Time: 150 min Stepwise ESD training program 20-50 cr-ESDs 30-50 g-ESDs ESD Colon Esoph ESD Stomach: body/fundus/cardia Gastric ca. incidence 4-8 times higher in East Asia Experts available ESD Stomach:Rectum antrum Expert Assistance Expert Observation Expert Observation Pre-required skills Animal models Western ESD preop. Training Expert Observ. Japanese center ANIMAL model n. ESD location 12 Stomach Catalano F Surg Endosc 2009 YES (?) No Dinis-Ribeiro M GIE 2009 YES (?) YES (?) Probst A CGH 2009 YES (short) No 82 Mix Coda S Gastric Cancer 2010 YES (3 mos) YES (20) 25 Mix Farhat S Endoscopy 2011 - - 188 Mix Repici A GIE 2010 No YES (?) 20 Esoph Iacopini F GIE 2012 YES (2 wks) YES (6) 60 Colorectal Stomach Gastrointest Endosc 2012 Prospective, Single center / single endoscopist no previous ESD experience ESD Colon no supervision Competence r-ESD (80% en bloc R + signif ↓ op. time) •ESD Stomach Rectum (+ retraining) •antrum 2-wks Expert center visit (NCCH, Tokyo) •Assistance Observed 40 ESDs + 1 ex-vivo ESD supervised Animal ex-vivo model (EETC, Catholic Univ, Rome) •Observation 5 ESDs, unsupervised •Pre-required skills Gastrointest Endosc 2012 20 En bloc Perforation 20 23 (77%) 18 (60%) 1 (3%) 2 (7%) Nikkō Tōshō-gū NCCH Tokyo Feb 2009 Listen Talk Look Feb 2010, 10th r-ESD Takuji Gotoda Guido Costamagna Oct 2012, 44th c-ESD Oct 2013, 71st c-ESD Yutaka Saito Takahisa Matsuda Western ESD Training Case Volume & Training duration Stomach Rectum n.ESD/month n.ESD/month 3 (188) Kakushima ’06 5 (90) Yamamoto ’09 1 (25) Rosch ‘04 <1 (19) Dinis-Ribeiro ’09 <1 (12) Catalano ‘09 1 (84) Probst ’10 Onozoato ’07 <1 (35) Ishii ‘10 <1 (33) Probst ’12 1 (71) Iacopini ’12 <1 (30) Repici ‘13 4 (40) c-ESD: perforation risk Experience and Case volume/yr Prospective, Multicenter (10 specialized Japanese istitutions) 1111 ESDs in 10-yr period (n.3) (n.3) (n.4) Saito Y. GIE 2010 c-ESD Perforation Management Lee EJ. Surg Endosc 2013 Single center Saito Y. Gut Liver 2013 Single center Abstr Fismad 2014 Seoul, Korea NCCH, Tokyo Albano L, Roma Endoscopist Experts Experts Trainee Design Retrosp Retrosp Prosp n. ESD 1000 806 *** 129 *** 53 (5%) 23 (3%) 7 (5%) From Incidence Iacopini F Intra 7 (100%) Post 0 Conservative ther Surgery for perforation 50 21 4 3 (6%) 2 (9%) 3 (43%) Colonic superficial neoplasms ESD vs. Laparoscopic Surgery 589 intramucosal / slightly sm invasive cancers Retrospective, single center (NCCH, Tokyo) 99 96 100 80 ESD LAC 60 5% perforation managed endo in 93% 40 20 *4 13 2 5 0 0 hospital stay (day) oral intake (day) 3-yr surv rate 4 stoma 6 14 complications Rectal superficial neoplasms ESD vs. TEM intramucosal / slightly sm invasive cancers ESD 30 vs. TEM 33 Retrospective, single center (Korea) * * * Park SU. Endoscopy 2012 Trattamento delle lesioni mucose estese del colon recidiva Trattamento delle lesioni mucose estese del colon recidiva • Rates of local recurrence: •en bloc resection 4.0% •piecemeal resection 17.0% • Importantly, when preoperative diagnosis was carried out in detail, recurrent lesions were usually found to be adenomas and additional endoscopic treatment was successful in attaining complete cure. • In fact, obvious adenoma can be radically cured by EMR, including piecemeal resection and, therefore, the use of ESD should be naturally regarded as overtreatment. Trattamento delle lesioni mucose estese del colon recidiva Two-step endoscopic piecemeal resection Performed in two scheduled sequential steps: 1° step: remove as much of the lesion as possible (intent to R0) 2° step: 4 to 6 weeks later for completion of the preceding resection In the 2° step: magnified inspection of the resection margins - scar tissue devoid of any pattern biopsy - residual adenoma resection or APC Cipolletta L, Gastrointest Endosc 2010;72:467-8 Trattamento delle lesioni mucose estese del colon recidiva Two-step endoscopic piecemeal resection Cipolletta L, Gastrointest Endosc 2010;72:467-8 Trattamento delle lesioni mucose estese del colon recidiva Two-step endoscopic piecemeal resection 1.9.2009 – 01.09.2011 54 pazienti (35M) – età media 68 anni (range 27-82) Tutte lesioni ≥ 30 mm (range 30-75 mm) -23 polipi sessili e 31 LST 24 mo-residual/recurrence 1/53 (1.9%) U.O. Gastroenterologia – Torre del Greco Trattamento delle lesioni mucose estese del colon Colorectal superficial neoplasms EMR vs. ESD outcomes prospective studies lesion size >20 mm Moss A. Gastroenterology 2011 multicenter (7) Nakajima T. Surg Endosc 2013 multicenter (18) EMR (n.514) EMR (n.1029) ESD (n.816) 36 (20–100) 26 (20–120) 39 (20–174) 4 resection/lesion 55 95 n.a. 34 95 25 ±22 18 ±23 96 ±69 Perforation (%) 1.3 0.8 2 Recurrence (%) 27 Size (mm) En bloc (%) for size >30 mm Procedure time (min) for size >40 mm 41 for specimens >6 34 4 n.a. (1111 ESDs) Saito Y. GIE 2010 Prospective – 2 expert centers 252 adenomas >20 mm Size: 33 mm (20-100) Morph: Flat 86% + Sessile 14% • • • • • Resection Complete Piecemeal Multiple sessions APC required Perforation (%) 98 89 4 50 1.6 Am J Gastroenterol 2014 Residual (at 6 mos) (%) 32 Recurrences (at 12 mos) 11 Scar- / Histology+ Scar not identified Drop out 33 10 41 Follow-up schedule Time intervals Retreatment Patient Adherence Cost EMR ESD Close Frequent Surveillance guidelines High / Important / High / Trattamento delle lesioni mucose estese del colon conclusioni… indicazioni alla resezione piecemeal o en-bloc • Le indicazioni in medicina sono sacre ma si modificano in base: alle nuove conoscenze alle nuove tecnologie ad aspetti etici ad aspetti socioeconomici alla diffusione di culture e tradizioni diverse (Giappone vs occidente) … Trattamento delle lesioni mucose estese del colon conclusioni… indicazioni alla resezione piecemeal o en-bloc • 0 – IIa, homogenous type < V EPMR Pit pattern V en-bloc • 0 - IIa + Is, focal mixed nodular type < V EPMR Pit pattern V en-bloc • 0 - Is + IIa, whole nodular type en-bloc Digestive Endoscopy (2009) 21 (Suppl. 1), S43–S46 Trattamento delle lesioni mucose estese del colon conclusioni… indicazioni alla resezione piecemeal o en-bloc • 0 – IIa (Flat Elevated) < V EPMR Pit pattern V en-bloc • 0 – II c + IIa (Pseudo Depressed) en-bloc Digestive Endoscopy (2009) 21 (Suppl. 1), S43–S46 Trattamento delle lesioni mucose estese del colon conclusioni… indicazioni alla resezione piecemeal o en-bloc HD Stain Chromoendoscopy Pit pattern vs HD Enhanced Endoscopy Trattamento delle lesioni mucose estese del colon conclusioni… indicazioni alla resezione piecemeal o en-bloc Studio prospettico multicentrico – 46 centri di endoscopia 928 pazienti 1012 ER di lesioni > 10 mm Lift & Cut ESD 100 % 80 98,3 95,6 60 40 20 0 1,7 Globale 4,4 385 lesioni > 25 mm 17 ESD 8 “pure” (retto) 9 “miste” 1 trasverso 3 sigma 5 retto conclusioni… Strategy for sup. CR neoplasms JSCCR guidelines 2010 Tanaka S. Dig Endosc 2013 conclusioni… ESD uptodated in the West Swanstrom LL. Treatment of early colorectal cancers: too many choices? Endoscopy 2012;44:991–2 • “it is a SHAME that the vast majority of patients worldwide with EARLY COLORECTAL CANCERS are subjected to COLON RESECTIONS. • This is WASTEFUL OF RESOURCES and really is NOT OPTIMAL CARE for the patient. • There should be an INTERNATIONAL DRIVE to get surgeons and gastroenterologists up TO SPEED ON ESD, so that all patients have ACCESS TO THE “BEST” TREATMENT for these tumors Hiromi Shinya was born in 1935 in the city of Yanagawa
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