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