Accepted Manuscript

EUS-guided drainage of peripancreatic fluid collections with lumen-apposing metal

stents and plastic double-pigtail stents: comparison of efficacy and adverse event
rates

Gabriel D. Lang, MD, Cassandra Fritz, MD, Trisha Bhat, Koushik K. Das, MD, Faris
M. Murad, MD, Dayna S. Early, MD, Steven A. Edmundowicz, MD, Vladimir M.
Kushnir, MD, Daniel K. Mullady, MD
PII: S0016-5107(17)32077-1
DOI: 10.1016/j.gie.2017.06.029
Reference: YMGE 10644

To appear in: Gastrointestinal Endoscopy

Received Date: 24 February 2017

Revised Date: 0016-5107 0016-5107
Accepted Date: 20 June 2017

Please cite this article as: Lang GD, Fritz C, Bhat T, Das KK, Murad FM, Early DS, Edmundowicz
SA, Kushnir VM, Mullady DK, EUS-guided drainage of peripancreatic fluid collections with lumen-
apposing metal stents and plastic double-pigtail stents: comparison of efficacy and adverse event rates,
Gastrointestinal Endoscopy (2017), doi: 10.1016/j.gie.2017.06.029.

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 ACCEPTED MANUSCRIPT

EUS-guided drainage of peripancreatic fluid collections with lumen-apposing

metal stents and plastic double-pigtail stents: comparison of efficacy and adverse
event rates

Gabriel D. Lang MD1, Cassandra Fritz MD2, Trisha Bhat3, Koushik K. Das MD1, Faris M. Murad
MD4, Dayna S. Early MD1, Steven A. Edmundowicz MD5, Vladimir M. Kushnir MD1 and Daniel K.

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Mullady MD1
1
Washington University in Saint Louis, Department of Gastroenterology, 2Washington

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University in Saint Louis Department of Medicine, 3Washington University School of Medicine,
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Northshore University Health System, Department of Gastroenterology and 5University of
Colorado, Division of Gastroenterology

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Corresponding Author:

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Daniel K. Mullady MD
Associate Professor of Medicine
Division of Gastroenterology
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Washington University in St. Louis
660 S. Euclid Avenue
Campus Box 8124
Email: mulladyd@wustl.edu
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Office: 314-454-5960
Fax: 314-454-5005
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 ACCEPTED MANUSCRIPT

Abstract

Background and Aims: Transmural drainage with double-pigtail plastic stents (DPPSs) was the
mainstay of endoscopic therapy for symptomatic peri-pancreatic fluid collections (PPFCs) until
the introduction of lumen-apposing covered self-expanding metal stents (LAMSs). Currently,
there is limited data regarding the efficacy and adverse event rate of LAMS compared with
DPPS.

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Methods: A retrospective analysis of EUS-guided PPFC drainages at a single tertiary care center
between 2008 and 2015 was performed. Patients were classified based on drainage method:

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DPPSs and LAMSs. adverse event rates, unplanned endoscopic procedures/necrosectomies, and
PPFC resolution within 6 months were recorded. Significant bleeding was defined as
necessitating transfusion or requiring endoscopic treatment/radiographic embolization.

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Subsequent endoscopic procedures were defined as unplanned procedures; stent removals
were excluded.

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Results: A total of 103 patients met inclusion criteria (84 DPPSs, 19 LAMSs). PPFCs were
classified as walled-off necrosis (WON) in 23 (14 DPPSs, 9 LAMSs). There were significantly
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more bleeding episodes in the LAMS group: 4 (19%: 2 splenic artery pseudoaneurysms, 1
collateral vessel bleed, 1 intracavitary variceal bleed) (p=0.0003) compared with 1 (1%, DPS
erosion into gastric wall) in group 1. One perforation occurred in the DPPS group. Unplanned
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repeat endoscopy was more frequent in the LAMS group (10% vs 26%, p=0.07). Among
retreated LAMS patients in with WON, 5 (56%) had obstruction by necrotic debris. In patients
for whom follow-up was available, 67/70 (96%) with DPPSs and 16/17 (94%) with LAMSs had
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resolution of PPFCs within 6 months (p=0.78).

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Conclusions: DPPSs and LAMSs are effective methods for treatment of PPFCs. In our cohort, use
of LAMSs was associated with significantly higher rates of procedure related bleeding and
greater need for repeat endoscopic intervention.
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Introduction

Peri-pancreatic fluid collections (PPFCs) result from acute pancreatitis, chronic

pancreatitis, trauma, malignancy and surgery. Drainage is indicated when PPFCs cause

symptoms including abdominal pain, gastric outlet obstruction, biliary obstruction, and
 ACCEPTED MANUSCRIPT

infection. EUS-guided transmural drainage has become a standard first-line therapy of

symptomatic PPFCs with success rates comparable with percutaneous and surgical

interventions1. An EUS-guided transmural approach allows avoidance of intervening

blood vessels, assessment of PPFC wall thickness, the shortest distance for access,

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and for assessment of solid components within the fluid collection. Furthermore,

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endoscopic management is associated with decreased morbidity, hospital length of

stay, and cost when compared with surgery1-7.

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Traditionally, EUS-guided drainage of PPFC was performed with tools adapted

from EUS-guided fine-needle aspiration and wires and double-pigtail plastic stents

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(DPPS) for endoscopic retrograde cholangiopancreatography. Although the DPPS
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design diminishes the risk of migration and is affordable, there are limitations associated

with their use. DPPSs have a small stent diameter, which makes them prone to
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occlusion and more frequent re-interventions. These stents are also more technically
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challenging to place and require repeated wire access across the PPFC, which is time-
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consuming for the physician8-10. Draining PPFCs with DPPSs may require multiple

stents11-14 and multiple revisions8, 15 to achieve resolution particularly in the setting of

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walled-off necrosis.

A dedicated device for management of PPFCs is now available as an alternative

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to the traditional DPPSs. This lumen-apposing covered self-expanding metallic stent

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(LAMS) has a bi-flanged wide lumen design, which may reduce stent migration and can

serve as a conduit for direct endoscopic necrosectomy. Previous non-comparative

studies have shown that the rates of stent migration are lower in DPPSs (0.7%-1%)

compared with LAMSs (5.3%-6.8%). The rates of stent occlusion (2.7%-13.6% vs 3.4%-
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7%), bleeding (0.7%-5.1% vs 3.4%-7.3%), and perforation (3.7%-4.2% vs 0%-1.8%) all

are higher for DPPSs compared with LAMSs7, 10, 16-22. Although the LAMS is a dedicated

device for PPFC drainage and has technical advantages compared with DPPSs, there

are little data regarding adverse events, specifically early and late bleeding rates.

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The aims of our study were to evaluate the efficacy of drainage of LAMSs

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compared with DPPSs for PPFCs, defined as the resolution of the PPFC on cross-

sectional imaging 6 months after the initial endoscopic intervention, and to assess

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adverse event rates between the DPPS and LAMS groups.

Methods
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This study was a retrospective analysis of EUS-guided PPFC drainages
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performed at a single tertiary care center between 2008 and 2015. The study was
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approved by the Washington University Institutional Review Board. Six experienced

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endoscopists performed all procedures. The study concept, hypothesis, and design

were initiated by the investigators, and no financial support or devices were received.
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All patients undergoing EUS-guided PPFC drainage for pancreatic pseudocyst

(PP) or walled-off necrosis (WON) between 2008 and 2015 were considered eligible for
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inclusion. All patients were consented to undergo an EUS with PPFC drainage. Patients
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were identified from a prospectively maintained database.

The baseline patient demographics, etiology of pancreatitis, size and type of

PPFC, type of stent used, procedural indications, technical details and adverse events

were all recorded from inpatient and outpatient medical records. Before initial EUS, all
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patients underwent cross sectional imaging via computed tomography (CT) or magnetic

resonance imaging (MRI). Both PPs and WON were defined per the 2012 revised

Atlanta classification23. PPs were defined as an encapsulated collection of fluid with a

well-defined wall with minimal or no necrosis. WON was defined as a mature

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encapsulation of pancreatic or peri-pancreatic necrotic tissue contained within an

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enhancing wall of reactive tissue. Inclusion criteria included the following: (1) age >18

years, (2) drainable fluid collection by EUS, (3) absence of coagulopathy (defined as

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INR <1.5 and platelets > 50,000/mm3), and (4) absence of antiplatelet agents and

anticoagulants agents, (5) presence of pseudoaneurysm within the PPFC, (6) splenic

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vein thrombosis, (7) greater than 6 months of follow-up.
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All endoscopic procedures were performed with the patient under general

anesthesia or monitored anesthesia care (MAC), as per the discretion of the attending
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anesthesiologist and endoscopist. EUS procedures were performed with linear

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echoendoscopes (Olympus America, Center Valley, Pa) and with fluoroscopy. The
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PPFC was evaluated for the presence of solid debris. The type and dosage of

antibiotics were administered at the discretion of the treating physician.

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Before intervention, all patients received cross-sectional imaging of the abdomen

with either computed tomography (CT) or magnetic resonance imaging (MRI). Imaging
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was used to assess the maturity of the collection for adequacy of endoscopic drainage
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as well as for presence of pseudoaneurysms or splenic vein thrombosis. The PPFC was

then evaluated with color Doppler to ensure lack of intervening blood vessels and to

ensure that the PPFC was within 10 mm of the EUS transducer. The PPFC drainage

procedures were performed using the gradated dilation technique24. A 19-gauge access
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needle (Cook Medical, Winston-Salem, NC) was introduced into the PPFC, and a long

0.035-inch guidewire was then advanced into the collection and coiled under

fluoroscopic guidance. The needle was subsequently removed. The tract was then

dilated with a dilating catheter, balloon dilator (6 mm) or needle-knife catheter.

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Subsequently a larger caliber balloon dilator (range 8-15 mm), was used to dilate the

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cyst-enterostomy tract. After dilation, either plastic double-pigtail stents (7F or 10F Cook

Medical, Winston-Salem, NC) or LAMS (AXIOS, Boston Scientific; Marlborough, Mass)

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were deployed. The performing physician determined the number of DPPSs placed,

size of LAMS (10 or 15 mm), debridement on the initial endoscopy, balloon dilatation of

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the LAMS, and whether or not a DPPS was placed through the LAMS. If a DPPS was
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placed through an LAMS, a 7F or 10F DPPS was placed over-the-wire under

endoscopic and fluoroscopic guidance into the collection with the internal pigtail inside
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the collection and the external pigtail in the lumen of the stomach or duodenum. Stents
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were removed endoscopically at a time period determined by the treating endoscopist.

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All patients received a phone call 48 to 72 hours after the procedure and had a clinical

encounter with an attending physician via a clinic appointment or procedure within 4

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weeks of their index drainage procedure. A CT scan was obtained in all patients

between 2 to 4 weeks after the procedure to evaluate for resolution of the fluid
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collection. Stent removal was performed at the discretion of the endoscopist after
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resolution of the PPFC was observed.

Before 2014, LAMSs were not available at our institution. As such, all PPFC

drainage procedures before 2014 were performed with DPPSs. From 2014 onward, the
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decision to drain PPFCs with either DPPSs or LAMSs was up to the performing

endoscopist.

Some patients, at the discretion of the endoscopist, underwent ERCP to assess

for a pancreatic duct leak These procedures occurred either before, concomitantly or

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after PPFC drainage. If the ERCP was performed within 90 days of the cyst-

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enterostomy it was counted in the analysis. ERCPs were performed with the patient

under monitored anesthesia care or general anesthesia. Pancreatic duct cannulation

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was attempted with a sphincterotome and guidewire of the endoscopist’s choosing.

Once pancreatic duct cannulation was achieved, contrast was injected to confirm

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intraductal location and to assess for extravasation of contrast. If a pancreatic duct
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disruption was noted, this was treated with sphincterotomy and the placement of a

plastic stent. The caliber and length of stent were determined by the treating physician.
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If there was evidence of pancreas divisum on prior cross-sectional imaging or during the
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ERCP, cannulation of the minor papilla was performed with similar steps performed as
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above.
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Outcome Measures
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The primary endpoints included radiographic resolution of the fluid collection

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within 6 months of the index endoscopic procedure and the occurrence of adverse

events including bleeding, perforation and unplanned endoscopic interventions.

Bleeding was defined as that necessitating transfusion or requiring hospitalization,

upper endoscopy, or a procedure by interventional radiology. Adverse events were

 ACCEPTED MANUSCRIPT

characterized as either immediate (less than 24 hours), early (1-7 days) and late (after 7

days) as defined by the ASGE (American Society for Gastrointestinal Endoscopy)

lexicon25. Planned stent changes and stent removals were not counted as an unplanned

endoscopic procedure. The primary and secondary endpoints, including technical

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success, clinical success, and rates of PPFC resolution were compared between the

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LAMS treatment group and double-pigtail plastic stent treatment groups.

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Statistical Analysis

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Subjects were divided into 2 groups: (1) those who underwent drainage using a
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DPPS; and (2) those who underwent drainage using an LAMS. Continuous variables

were summarized as means (with standard deviations) and medians (with ranges).
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Continuous variables were compared using the Student t-test. Categorical variables
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were expressed as frequencies and proportions. They were analyzed using the Pearson
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Chi-square. All statistical analyses were performed using PASW 19.1 (SPSS, Inc,

Chicago, Ill). A 2-sided P-value < 0.05 was considered statistically significant.
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Results
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Study Population
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A total of 207 patients with PPFCs were identified from 2008 to 2015. Of these,

104 patients were ineligible: 31 patients were treated with fully covered self-expandable

metallic stents (FCSEMSs), and 73 underwent either cyst aspiration or no endoscopic

 ACCEPTED MANUSCRIPT

drainage procedure. 103 patients were included in the final analysis (Figure 1). The

mean age of patients was 51.6 years (range 18-76). There were 62 males (60%) and 41

females (40%). Based on the Atlanta Classification, 80 patients had PPs (78%), and 23

patients had walled-off necrosis (22%) (Figure 1). The most common etiologies of

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pancreatitis were gallstone (32%), hypertriglyceridemia (19%), alcohol (6%), and

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idiopathic (32%) (Table 1).

Among the 84 patients treated with DPPSs, 70 (83%) had pseudocysts and 14

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(17%) had WON. In patients treated with DPPSs, the mean diameter of the fluid

collection was 88 mm (range 41-178 mm). Among the 19 patients treated with LAMSs,

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10 (53%) had pseudocysts and 9 (47%) had WON. The mean diameter of PPFCs in this
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group was 104 mm (range 67-155 mm).
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Drainage Procedure
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Table 2 depicts the characteristics of each drainage procedure. The majority of

collections (95) were approached from the stomach (92%) whereas 8 were approached
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from the duodenum (8%). All of the patients who received an LAMS were drained via

cyst-gastrostomy. The median number of DPPSs used to treat patients with

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pseudocysts and WON was 2 (range 1-3).

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There were 3 necrosectomies performed at the time of initial drainage in the

DPPS group compared with 2 in the LAMS group. There was one subsequent

necrosectomy performed in the DPPS group compared with 13 in the LAMS group. The

median number of subsequent necrosectomies in both the DPPS and LAMS group was
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1. Three patients (33%) with WON drained with LAMS had a DPPS placed through the

metal stent at the time of their initial drainage procedure. Stents were removed at a

range 3 weeks to indefinite placement.

Twenty-nine patients (26 DPPSs, 3 LAMSs) underwent ERCP to assess and

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treat a pancreatic ductal disruption. A pancreatic duct leak was identified in 23 patients

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(20 DPPSs and 3 LAMSs). Three DPPS patients had no leak identified and another 3

DPPS patients were recognized as having pancreas divisum, but the minor papilla could

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not be cannulated.

Technical and Clinical Success

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The overall technical success rate in this study was 99%. The overall clinical
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success rate as determined by complete resolution at 6 months was 95%. The clinical
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success rate was 96% and 94%, respectively, for those treated with DPPSs and LAMSs
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(p>0.05) (Figure 2). There were 4 episodes (3 DPPSs, 1 LAMS) of PPFC recurrence

(3.9%).
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Adverse Events
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Adverse events were observed in 19 of 103 patients (18%). Nine patients treated

with DPPSs (12%) had adverse events compared with 10 (53%) treated with LAMSs

(p=0.0003) (Figure 3). Further details regarding the nature of the adverse events can be

found on table 3.
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One perforation occurred in the DPPS group. This was treated surgically, with

over-sewing of the gastric perforation. The patient had a surgical cyst-gastrostomy

performed and recovered well. There were 8 unplanned endoscopic procedures (10%,

1 early and 7 late) in the DPPS group versus 5 (26%, 1 early and 4 late) in those

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drained with LAMSs (p=0.07) (Table 3). When only patients with WON were

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investigated (14 patients in the DPPS group and 9 patients in the LAMS group) there

were 7 unplanned endoscopies (50%) in patients treated with DPPS compared with 7

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(78%) in those treated with LAMSs (p=0.18). Five patients with WON who were drained

with LAMSs (56%) had obstruction of the stent lumen by necrotic debris and in 4 of

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these cases a DPPS stent was placed within the metal stent. There were no further
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unplanned endoscopic procedures after a DPPS was placed through the LAMS.

In the DPPS group, there was 1 episode of bleeding (1%) compared with 4 (21%)
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in the LAMS group (OR, 22.1; 95% CI, 2.3 - 211.9) and was statistically significant
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(p=0.0003). The bleeding episode in the DPPS group was secondary to a plastic stent
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erosion into the opposite gastric wall. An EGD was performed, and a visible vessel was

treated with cautery for durable hemostasis and the stent was repositioned. This
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occurred 30 days after cyst-gastrostomy. In those treated with LAMSs, 4 bleeding

episodes were noted. One occurred secondary to an intra-cavitary vessel bleed, which
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was treated endoscopically using balloon tamponade 14 days after cyst-gastrostomy.

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The second episode occurred during insertion of the LAMS. This bleeding event was

thought to be secondary to a collateral vessel bleed and was managed conservatively.

The patient was admitted and transfused 2 units packed red blood cells but no further

bleeding was noted. The remaining two patients in the LAMS group had bleeding from
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splenic artery pseudoaneurysms. One patient underwent left gastric and splenic artery

embolization with successful hemostasis 12 days after cyst-gastrostomy. The second

patient died before his embolization procedure. This event occurred 15 days after his

PPFC drainage.

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Discussion

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EUS-guided drainage is well recognized as the procedure of choice for

symptomatic PPFCs associated with a technical success rate >90% and a clinical

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success rate of at least of 75%19, 26-28. However, there are minimal data regarding the
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optimal stent for drainage and the adverse event rate associated with each type of
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stent. In this study we determined that DPPSs and LAMSs had equal rates of clinical

success, but there was a significantly greater number of adverse events, namely
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bleeding events and unplanned endoscopies, with LAMSs compared with DPPSs.
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The initial stent used for endoscopic PPFC drainage was the DPPS. It is a non-

specific tool for this purpose and its use was adapted from its role in biliary endoscopy.
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DPPSs have a 93.6% clinical success rate with a single stent and 97.4% success rate

with multiple stents29. DPPSs perform well for pseudocyst drainage with a clinical
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success rate of 88% to 98% but perform significantly worse in WON with clinical
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success rates of 63% to 70%20-22, 30. PPFCs drained with plastic stents have been noted

to have had unplanned stent changes or necrosectomies in up to 27% of cases9-11, 14, 15.

A recent report by Siddiqui et al31 found that the mean number of procedures required

for resolution of WON was higher for DPPSs compared with FCSEMSs or LAMSs (81%
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vs 95% vs 90%, p=0.001). On multivariate analyses, DPPSs were the only negative

predictor for successful resolution of WON.

The small caliber of DPPSs is thought to be responsible for high rates of stent

occlusion and superimposed infection. Furthermore, multiple DPPSs are technically

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challenging to place, and as such, FCSEMSs were subsequently used for the drainage

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of PPFCs. FCESMSs have a more straightforward deployment mechanism and a

larger-diameter lumen. This allows for a more efficient drainage and longer patency15, 16,

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. It is thought that this wider diameter decreases the probability of secondary infections

and need for re-interventions33. Unfortunately, these stents have a higher rate of

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migration34 which can result in leakage and inefficient drainage. The overall technical
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and clinical success rates of FCSEMSs are 78% to 100% and 81% to 94%,

respectively10, 21, 22, 28, 31. Sharaiha et al19 described adverse event rates of FCSEMSs in
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16% of patients, although multivariate analysis revealed patients with plastic stents
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were 2.9 times more likely to experience adverse events than those treated with
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FCSEMSs.

The LAMS is a dedicated device for EUS-guided drainage of PPFCs with a

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stepwise deployment mechanism. Its biflanged shape allows for tissue apposition and

decreases the risk of stent migration. Its wide-diameter lumen provides a conduit for
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direct endoscopic necrosectomy and may lead to improved drainage and obviate the
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need for repeat endoscopies. LAMSs have very high rates of technical (89%-100%) and

clinical (93%-100%) success3, 11, 16-18, 22, 35, 36. Early reports using LAMSs have

demonstrated a 5% adverse event rate16 including one pseudoaneurysm and one stent

occlusion in 33 patients. A multicenter retrospective study by Siddiqui et al18 that

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examined EUS-guided drainage of symptomatic PPFCs in 82 patients found a 9.8%

adverse event rate, including 2 stent mal-deployments and 6 episodes of self-limited

bleeding. There were also a total of 5 (6%) episodes of PPFC infection, 4 of which were

documented to be stent occlusion by necrotic debris.

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Due to its simplified deployment mechanism, direct debridement access and

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ease of use, LAMSs have become the preferred stent for endoscopic drainage of

PPFCs by many gastroenterologists. Direct single-center comparative studies of plastic

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stents to LAMSs are limited, however. In the present study, 11% of patients who

underwent drainage with DPPSs had an adverse event compared with 53% of patients

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treated with LAMSs (p=0.0003). In particular, rates of bleeding were higher for LAMSs
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versus DPPSs (21% vs 1%). In addition, Siddiqui et al described increased early

adverse secondary to LAMSs compared with FCSEMSs and DPPSs (OR, 6.6;
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p=0.02)31.
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Although this investigation is retrospective in nature and does not allow for a
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direct investigation of why rates of bleeding are increased with PPFC by LAMSs, the

authors similarly to Bang et al37 speculate that perhaps the rapid decompression of the
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cyst cavity afforded by the LAMS causes friction or irritation of the vasculature within the

cavity and causes bleeding. Bang et al speculated that plastic stents likely migrate into
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the GI lumen as the PPFC resolves, whereas LAMSs remain in place secondary to their
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bi-flanged design37. Furthermore, the wide lumen of the LAMS may allow more entry of

gastric acid into the cyst cavity. This low pH fluid may irritate exposed intracavitary

vessels and promote bleeding.

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Although it is not uncommon for pseudoaneurysms to be found within PPFCs or

for collateral vessels to develop as a result of splenic artery thrombosis, neither the

pseudoaneurysms or splenic vein thrombosis were visualized on imaging or EUS before

the PPFC drainage procedure. If these factors are identified before PPFC drainage, the

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rate of bleeding after cyst-enterostomy is increased. It is the authors’ hypothesis that the

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aforementioned bleeding episodes occurred as a result of mechanistic changes after

PPFC drainage with LAMSs. Although this retrospective study is limited in postulating

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the etiology of these bleeding episodes, future prospective studies may be able to

elucidate which subset of patients and patient characteristics may predispose patients

to bleeding episodes after PPFC drainage.

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There was also a trend toward significance (p=0.07) of unplanned endoscopies

between the DPPS and LAMS groups (10% vs 26%). The majority of these unplanned
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endoscopies occurred late (greater than 7 days) after the index drainage procedure.
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The trend toward more unplanned endoscopies persisted when only patients with WON
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were evaluated (78% vs 50%). We hypothesize that the large lumen of the LAMS stent

leads to rapid decompression of the fluid component within a PPFC leaving behind
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large pieces of necrosis, which can become trapped within the lumen of the stent and

subsequently cause stent obstruction leading to infected necrosis. Double-pigtail stents,

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on the other hand, have side-holes throughout their length that may promote drainage
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through and alongside the plastic stents, which may prevent complete occlusion of the

outlet.

Three patients with WON drained with LAMSs initially had a DPPS placed

through their metal stents at the time of their initial drainage procedure. None of these 3
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patients had an unplanned endoscopy. Furthermore, of the 5 patients treated with

LAMSs who had an unplanned endoscopy, 4 (80%) were treated with debridement of

the collection and had subsequent placement of a DPPS. None of these 4 patients had

a subsequent unplanned endoscopy. The remaining patient treated with debridement

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alone required had a subsequent unplanned endoscopic procedure. We hypothesize

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that the drainage afforded by the side holes in DPPSs and drainage around the stent

(eg, capillary action or wicking) allow for an ongoing drainage and prevents complete

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occlusion of the LAMS lumen. Despite the fact that the rates of unplanned endoscopy

are higher for PPFCs drained via LAMSs, the overall rate of PPFC resolution was equal

between the groups.

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The primary limitation of the present study is its retrospective nature and

limitations inherent to this design. Another limitation is the lack of a true criterion
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standard for the treatment of WON. To date, there is no criterion standard in regard into
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the performance of an initial necrosectomy and dilation of the lumen of the LAMS. Our
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group’s primary practice is to perform necrosectomies on-demand, and only 4% of

DPPS and 11% of LAMS patients had a necrosectomy at the time of stent placement.
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Furthermore, the exact methods of drainage and techniques used in the creation of the

cyst-gastrostomy were not standardized across all patients. Before 2014, LAMSs were
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unavailable at our center. The LAMS patients studied here reflect our initial experience
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with this device. Despite significant training in the use of LAMS by all physicians in this

study, it is possible that a higher initial adverse event rate could reflect an initial learning

curve. The decision to place a DPPS through the LAMS and follow-up intervals for

repeated endoscopies were also not regimented across all practitioners who
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participated in this study. There was an unequal distribution of patients within the two

examined groups, with a smaller number of patients receiving LAMSs, this may limit

statistical comparisons between groups. Furthermore, there was a higher proportion of

patients who had WON and underwent a necrosectomy in the LAMS group compared

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with the DPS group. Last, long-term follow-up of patients was limited in this study likely

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secondary to the referral-based practice of this tertiary care center. This particularly

limited the calculation of long-term recurrence rates. Patients were followed until their

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PPFC resolved, but it is unknown how many PPFC recurrences truly occurred, as all

patients may not have been re-treated at our institution.

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In conclusion, this study showed that DPPSs and LAMSs are equally effective
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treatments for PPFCs and WON. However, LAMSs were associated with higher rates of

adverse events, specifically bleeding and the need for unplanned endoscopic
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procedures. Further prospective randomized studies assessing risk factors for

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procedural adverse events of EUS-guided treatment of PPFCs, the role of initial

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necrosectomy on long-term outcomes of PPFC resolution, and assessing the role of

DPPSs in conjunction with LAMSs are necessary to better understand the optimal stent
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and drainage procedure for symptomatic PPFCs.

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LEGENDS
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Figure 1. Demographic information on patients included in this study.

Table 1. DPPS, double-pigtail plastic stents; LAMS, lumen-apposing covered self-expanding

metal stents

Table 2. DPPS, double-pigtail plastic stents; LAMS, lumen-apposing covered self-expanding

metal stents
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Figure 2. Graph representing the clinical success, defined as resolution of peri-pancreatic fluid
collections within 6 months, of double-pigtail plastic stents (DPPS) and lumen-apposing covered
self-expanding metal stents (LAMS).

Figure 3. Graph depicting the overall adverse event rates of EUS-guided peri-pancreatic fluid
collection drainage by double-pigtail plastic stents (DPPS) and lumen-apposing covered self-

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expanding metal stents (LAMS).

Table 3. DPPS, double-pigtail plastic stents; LAMS, lumen-apposing covered self-expanding

metal stents

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Author Contributions:

Gabriel Lang: Wrote manuscript, data collection

Cassandra Fritz: Data collection
Trisha Bhat: Data collection
Koushik Das: Manuscript review, key idea contributor

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Faris Murad: Performed endoscopic procedures included in study
Dayna Early: Manuscript review, key idea contributor
Steven Edmundowicz: Performed endoscopic procedures included in study, manuscript review,
key idea contributor

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Vladimir Kushnir: Performed endoscopic procedures included in study, manuscript review, key
idea contributor

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Daniel Mullady: Senior author who came up with premise for study, performed endoscopic
procedures included in study, manuscript review.

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Acronyms:

PPFC: peri-pancreatic fluid collection

PP: pancreatic pseudocyst
WON: walled off necrosis
EUS: endoscopic ultrasound

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ERCP: endoscopic retrograde cholangiopancreatography
DPPS: double pigtail plastic stents
LAMS: lumen-apposing covered self-expanding metal stents
CT: computed tomography

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MRI: magnetic resonance imaging
INR: international normalized ratio

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MAC: monitored anesthesia care
ASGE: American Society of Gastrointestinal Endoscopy
FCSEMS: fully covered self-expandable metal stents

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