Endoscopic pancreatic necrosectomy in 2017

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1 Endoscopic pancreatic necrosectomy in 2017 Mouen Khashab, MD Associate Professor of Medicine Director of Therapeutic Endoscopy The Johns Hopkins Hospital

2 Revised Atlanta Classification Entity Acute fluid collection Acute necrotic collection Type of Pancreatitis Disease course. weeks Solid debris present? Encapsulated wall? Interstitial <4 No No Necrotic <4 Yes No Pseudocyst Interstitial >4 No Yes Walled Off Necrosis Necrotic >4 Yes Yes

3 Treatment Considerations Surgical management: Up to 35% adverse-event rate and 10% mortality EUS guided transmural drainage is a minimally invasive method for the management of pseudocysts Clinical trials have demonstrated that EUS-guided drainage is as effective as surgery, causes fewer adverse events, and is more cost-effective compared with surgery

4 GASTROENTEROLOGY 2013;145:

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6 Multicenter randomized controlled trial, endoscopic vs surgical treatment in 20 patients Endoscopic vs Surgical: Significant reduction in post-procedural IL-6 levels (P <0.004) Significant decrease in death and complications rates (20% vs. 80%; P=0.03) Significant decrease of new-onset multiorgan failure (0% vs. 50%; P=0.03) Fewer patients developed pancreatic fistula (10% vs. 70%; P=0.02) Bakker OJ, et al. JAMA 2012;307:

7 Conventional transmural drainage (CTD) vs EUS-guided drainage Advantages of CTD Larger working channel diameter Increased suction capacity Increased endoscope flexibility and endoscopic visualization

8 Conventional transmural drainage (CTD) vs EUS-guided drainage CTD is safe and effective in the presence of a visible endoscopic bulge and no obvious portal hypertension. Endoscopy 2006;38:355-9

9 Conventional transmural drainage (CTD) vs EUS-guided drainage Two RCTs of EUS versus CTD determined equivalency for bulging pseudocysts However, EUS was superior for those without a visible bulge because CTD was not possible Varadarajulu et al. Gastrointest Endosc 2008;68: Park et al. Endoscopy 2009;41:842-8.

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12 Conventional transmural drainage (CTD) vs EUS-guided drainage A subsequent meta-analysis concluded that EUS guidance results in higher technical success. TOP Pseudocysts need EUS because they rarely cause luminal compression, and drainage is often from the proximal stomach and requires consideration of the diaphragm and splenic vessels. Panamonta et al. Eur J Gastroenterol Hepatol 2012;24:

13 EUS-guided drainage technique Giovannini et al and Vilmann et al first described single-step EUS-guided pseudocyst drainage in 1998, and conceptually the procedure has remained similar since Giovannini et al. Gastrointest Endosc 1998;48: Vilmann et al. Endoscopy 1998;30:730-3.

14 Traditional EUS-guided pseudocyst drainage

15 Nasocystic catheter irrigation A nasocystic catheter provides the combined benefits of collection irrigation, additional drainage route, and reduction in transmural stent occlusion The main utility appears to be in WON and abscesses, in which continued irrigation and prolonged drainage is required There may be benefit in pseudocysts that are multiloculated or extend to the flanks

16 Gastrointest Endosc 2013;78:589-95

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18 Multiple transluminal gateway technique (MTGT) Varadarajulu et al. GIE 2011;74:74-80.

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20 What Stent to use? plastic or SEMS?

21 Digestive Endoscopy 2015; 27:

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23 Plastic stent group SEMS group Overall success rate, % Success rate for pseudocysts, % Success rate for WON, # Adverse events, % Recurrence, % 10 9

24 EUS-guided PFC drainage using a non LAS SEMS

25 GIE 2014

26 AXIOS Lumen Apposing Stent

27 AXIOS AXIOS is the first stent FDA cleared for drainage of pancreatic collections Enables a minimally-invasive EUS treatment option in place of surgery or percutaneous drainage Stent Sizes (diameter x length, mm) US 10x10 15x10 EU 10x10 15x10 Regulatory status US: 510(k) cleared for drainage of pancreatic pseudocysts (with up to 30% necrotic debris) EU: Indicated for drainage of pancreatic collections and biliary tree

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30 Hot AXIOS HOT AXIOS incorporates electrocautery into the tip Enables easy passage into the target body organ Can be introduced directly into the target organ under EUSguidance ( freestyle ), or can be introduced over a guidewire (no cystotome required) Stent Sizes (diameter x length, mm) Benefits Safety - reduces instrument exchanges and leak risk Dramatically reduces time of procedure Penetrates easily enabling access to non-adherent structures US 10x10 15x10 EU 6x8 8x8 10x10 15x10

31 Hot Axios Cautery Settings ERBE VIO 300

32 HOT AXIOS

33 Multiple transluminal gateway technique (MTGT) using LAS

34 Gastrointest Endosc 2016;83:

35 Endoscopic Therapy With Lumen-apposing Metal Stents is Safe and Effective for Patients With Pancreatic Walled-off Necrosis Sharaiha, Tyberg, Khashab, et al. CGH 2016 DEN 78 PD stent 19 H2O2 38 NCT 22 Median # of interventions was 2 (1-9)

36 GIE 2016

37 GUT 2016

38 Direct Endoscopic Necrosectomy (DEN)

39 WON: Direct Endoscopic Necrosectomy Baron TH, Kozarek RA. Clin Gastroenterol Hepatol 2012; 10:

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45 104 Patients 95 (91%) Successfully Treated 58% of procedures at one center Median number of procedures 3 (1-14) Median necrosectomies 2 (1-13) 9 (9%) Failed 6 died, 3 surgery Gardner TB, et. al. Gastrointest Endosc 2011; 73:

46 Gastrointest Endosc 2014; 79:

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48 Clinical Trials on WON Necrosectomy PANTER PENGUIN TENSION Study Design 88 patients Open necrosectomy vs. step-up approach (percutaneous drainage and minimally invasive debridement if needed) 22 patients Endoscopic necrosectomy vs. surgical necrosectomy 98 patients Endoscopic step-up vs. surgical step-up Conclusion Minimally invasive approach to infected necrosis superior to open surgery with respect to short and long term mortality and morbidity (death, organ failure, hernia, diabetes) Small randomized trial suggesting less mortality, organ failure or fistula Endoscopy superior in terms fistula rate, LOS and cost

49 Endoscopic or surgical step-up approach for necrotizing pancreatitis: a multicenter RCT (TENSION trial) Van Brunschot et al. DDW 2017

50 Patients with infected WON (n=98) Endoscopic transmural drainage (n=51) Percutaneous drainage (n=47) Endoscopic necrosectomy Video-assisted retroperitoneal debridement (VARD) Primary endpoint (composite of major AEs or death) Endo 43% vs Surg 45%, p=0.88 Death: 18% vs 13%, p=0.5 Secondary endpoints (pancreatic fistula, LOS, cost, etc) Fistula: 5% vs 32%, p=0.001 LOS: 53d vs 69d, p=0.01 Cost 13,655 (in favor of endo)

51 Take Home Points Endoscopic-step up approach is preferable when expertise is available Complex disease and multidisciplinary management is essential Endoscopic necrosectomy is not needed is a substantial proportion of patients (43%)

52 Conclusions EUS-guided drainage of PFC should be considered as the primary treatment strategy Pseudocysts and WON are 2 completely different entities Treatment of WON should be individualized Axios stent has made EUS-guided drainage of PFCs simpler and more efficient

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