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Treating Pancreatic Necrosis
Crescent City GI, Endoscopy, and Liver Disease Update
September 2019
Janak N. Shah, MD, FASGE
Department Chair – Gastroenterology and Hepatology
Director of Endoscopy
Ochsner Medical Center – New Orleans
Disclosures
Learning objectives
Pathways following acute pancreatitis
Acute pancreatitis in the USA~300,000 ED visits / yr
~275,000 hospitalizations / yr$2.5 billion health care costs in 2014
Pancreatic fluid collections (PFCs):Are we all speaking the same language?
PFC definitions CT findings
Acute peri-PFC
Peri-panc fluid w/i 4wks ofinterstitial edematous pancreatitis
Collection of fluid density confined to normal peripanc fascial planes, no definable wall, adjacent (not into) pancreas
Pancreatic pseudocyst
Encapsulated collection with minimal/no necrosis >4wks after interstitial pancreatitis
Well-circumscribed, defined wall, no solid component
Acute necrotic collection
Collection with variable amounts of fluid/necrosis involving pancand/or peri-panc tissue after episode of necrotizing pancreatitis
Heterogenous collection with non-liquid density, no definable wall
Walled-off necrosis (WON)
Encapsulated collection of panc/peri-panc necrosis with well-defined wall usually >4wks after necrotizing pancreatitis
Heterogeneous collection, varying liquid and non-liquid density, +/- loculations, intra or extra-pancreatic, well-defined wall, >4wks after necrotizing pancreatitis
Revised Atlanta classification 2012
Banks PA. Gut 2013
Acute necrotic collection
Walled-off necrosis
4 weeks
Who needs treatment of PFC’s (pseudocyst or walled-off necrosis) ?
Indications Comments
Infection or suspected infection ~20% in necrotizing pancreatitisRoutine FNA not needed- clinical signs accurately
predict >90%
Ongoing organ failure ~40% will have infected PFC
Mass effect causing GOO, biliary/bowel obstruction Less common
Persistent sxms >8 wks (pain, wt loss)
Bleeding into PFCRareAbdominal compartment syndrome
Bowel ischemia
IAP/APA acute pancreatitis guidelines. Pancreatology 2013ASGE guideline- role of endoscopy in pancreatic fluid collections. Gastrointest Endosc 2016
General principles for treating symptomatic PFCs
Acute peri-pancfluid or acute
necrotic collectionDELAY
Pseudocyst
(>4 wks)DRAIN
WON
(>4WKS)DRAIN / DEBRIDE
Improving outcomes with delay
Mier J. Am J Surg 1997
“Early vs. late necrosectomy in severe necrotizing pancreatitis”
Van Saantvoort HC. Gastro 2011
“Conservative and minimally invasive approach to necrotizing pancreatitis improves outcomes”
56%
26%
15%
0%
10%
20%
30%
40%
50%
60%
0-14 14-29 >29
Mortality based on time to intervention in 242 pts
Days to surgical, perc-IR, or endoscopic intervention
P<0.001
Van Santvoort et al. Dutch Pancreatitis study group. Conservative approach to
necrotizing pancreatitis. Gastro 20117%
mortality
78% mortality
87% perc / 13% endo
Treating necrotizing pancreatitis/WON:A step-up approach
Conservative management
Drainage (perc/endo) if
concern for infection / other sxms
Surgical or endoscopic
debridement (if needed)
IAP/APA evidence-based acute pancreatitis guidelines. Pancreatology 2013
Three RCTs from the Dutch pancreatitis study group in necrotizing pancreatitis needing intervention
• PANTER trial– step-up (drain then debride with video-assisted retroperitoneal [VARD], if needed) vs. primary open necrosectomy
• PENGUIN trial– endoscopic necrosectomy vs. surgical necrosectomy
• TENSION trial– endoscopic step-up (drain->debride) vs. surgical step-up (VARD-> open)
Step-up approach (drainage then VARD – if needed)
N=43
Open necrosectomyN=45
RR ; p-value
Major complications or death* 40% 69% 0.57 ; 0.006
Death 19% 16% ns
Pancreatic fistula 28% 38% ns
Incisional hernia 7% 24% 0.29; 0.03
New onset DM 16% 38% 0.43; 0.02
Need for pancreatic enzymes 7% 33% 0.21; 0.002
Total # operations 53** 91 P<0.001
New ICU stay at any time following 1st intervention
16% 40% 0.41; 0.01
Dutch Pancreatitis Study Group. PANTER trial. NEJM 2010
* Primary end-point – maj comp included new onset organ failure, EC fistula, perforation, bleeding requiring intervention ** 40% did not need surgical necrosectomy in step-up group
Dutch Panc Study Grp. PENGUIN trial. JAMA 2012
Dutch Panc Study Grp. PENGUIN trial. JAMA 2012
Endoscopic vs. surgical step-up in infected necrotizing pancreatitis- Dutch pancreatitis study Group – TENSION Trial
Endoscopic step-up vs. minimally-invasive surg step-up-TENSION trial (Dutch pancreatitis study group. Lancet 2017)
Endo step-up (n=51) Surgical step-up (n=47)
Primary end-point (major AE- new onset org failure, bleeding requiring intervention, perf or EC fistula requiring intervention, incisional hernia, or death)
43% 45% (p=NS)
Death 18% 13% (NS)
% not needing necrosectomy after initial drainage 43% 51% (p=NS)
Pancreatic fistula 5% 32% (p=0.001)
Mean length of stay 53 days 69 days (p=0.014)
costs Not significantly different
Authors interpretation- “In patients with infected necrotizing pancreatitis, the endoscopic step-up approach was not superior to the surgical step-up approach in reducing major complications or death. The rate of pancreatic fistulas and length of hospital stay were lower in the endoscopy group. The outcome of this trial will probably result in a shift to the endoscopic step-up approach as treatment preference.”
Direct endoscopic necrosectomy (DEN): Should it be performed without ‘step-up’ drainage in WON
requiring intervention?
Matched cohort study of DEN vs. conventional step-up
DEN (n=12)DEN performed at initial procedure without prior
drainage catheter (IR or endo)
Step-up (n=12)Drain followed by minimallyinvasive surgery (if needed)
Clinical resolution 11 (1 required IR drainage later) 3 with IR drain; 9 required VARD
Hospital length of stay Shorter with DEN
Health care costs 5x more with step-up
Kumar N. Pancreas 2014
Debridement of walled off necrosis:surgical or endoscopic?
Min-invasive Surgical
Endoscopic
When should surgery be considered for pancreatic fluid collections?
Endoscopic debridement of WON: challenges with conventional technique
From Brunschot. BMC Gastroenterol 2013
Puli S. Can J Gastro Hep 2014Brunschot S. Surg Endosc 2014
New technology for EUS-guided drainage / debridement of PFCs: Lumen-apposing stent (LAMS)FDA de novo approval as a class II device in 12/2013
• Multicenter trial, prospective trial; 33 patients with symptomatic PFC’s (pseudocysts=22, WOPN=11) enrolled from 7 centers from Oct 2011- Aug 2013
• Trial done under an investigational device exemption, and results used for FDA approval (Dec 2013)
• Technical success with LAMS – 91%
• PFC resolution – 91%
• Adverse events – 15% (abd pain-3, stent migration-1, stent dislodgement/infection-1)
Clin Gastro Hep 2015
Retrospective, multi-center study –17 US centers
N=124
Technical success 100%
Clinical success (>3 month f/u) 86%
Perc drains needed 11%
Surgery needed 2.4%
Sharaiha et al.
Case- 16yo with hx of necrotizing pancreatitis 4 months prior; now presenting with pain, and inability to tolerate solids
Summary – Treating pancreatic necrosis
Ochsner Medical Center – New Orleans