Study of a Lumen- Apposing, Covered, Self-Expanding Metal Stent (Axios™) Versus Multiple Double Pigtail Stents



Status:Terminated
Healthy:No
Age Range:18 - 80
Updated:1/31/2019
Start Date:February 2016
End Date:December 18, 2017

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Randomized, Multi-Center, Comparative and Cost Effectiveness Study of a Lumen- Apposing, Covered, Self-Expanding Metal Stent (Axios™) Versus Multiple Double Pigtail Stents in the Management of Walled Off Pancreatic Necrosis

The present study aims to compare the clinical efficacy and cost effectiveness of the AXIOS™
stent versus the "conventional" approach using double pigtail plastic stents in the treatment
of patients with walled-off pancreatic necrosis.

Acute pancreatitis (AP) is responsible for nearly a quarter million hospital admissions
annually and will affect around 40 per 100,000 persons per year (1). The majority of patients
experience a clinically mild course; however, as many as one in five patients develop a
severe illness associated with a high mortality (2). In early phases of the disease, there is
an acute inflammatory process that may involve necrosis of the pancreatic or peri-pancreatic
tissues (3). There are also delayed complications that may develop locally, usually over a
period of weeks, which include the formation of walled-off fluid collections. These are
sometimes composed of simple fluid and termed pseudocysts, while in other cases they
represent organization and encapsulation of sterile or infected necrosis and are termed
walled-off pancreatic necrosis (WOPN) (4). The indication to drain or debride these
collections usually depends upon on a number of factors, but principally on whether they are
symptomatic, infected, or responsible for other local or systemic complications.

The contemporary management strategy for walled-off pancreatic fluid collections has shifted
in recent years. Surgery, and even percutaneous catheter drainage, should no longer be
considered the initial mainstay of therapy in place of endoscopic drainage for simple
pseudocysts (5) (6). In addition there is good evidence to support an endoscopic approach for
patients with infected necrosis (7). There are now numerous publications reporting the
success of direct endoscopic transmural drainage or necrosectomy (ETD/N) for a variety of
indications including infected and sterile walled-off collections (8).

The issue that now deserves attention is a matter of selecting the best technique to
accomplish ETD/N. The current process involves first creating a cystenterostomy to gain
access to the walled-off collection, dilating the tract, and then inserting a drainage
device. However, there are a variety of available devices and methods in use for drainage,
and to our knowledge, none to date have been directly compared in a randomized controlled
trial.

The conventional approach involves inserting either a pair or more of plastic double pigtail
stents or a self-expanding metal stent (SEMS) through a cystenterostomy: both approaches have
limitations, and may require multiple endoscopic sessions before definitive resolution (9).
One, the pigtail stents have a narrow lumen (7F-10F) and often migrate or become occluded
(10). Two, the SEMS also have a tendency occlude, cause local trauma with bleeding and
infection, and migrate, which has led some to also use double pigtails to help anchor the
SEMS in place (11) (12).

These challenges have led to the innovation of large caliber covered stents with flanges on
either end to facilitate apposition of the cyst wall and enteral tissues, preventing
migration, and allowing for necrosectomy through their wide lumen. To our knowledge there are
at least two designs in production; the AXIOS™ stent and the Nagi stent (13) (14). There is
now a fair amount of experience, particularly using the AXIOS™ stent (with or without a novel
NAVIX access system) for both WOPN and pseudocysts, with the majority of reports showing it
to be safe and effective (15) (16) (17) (18) (19) (20). The device has also been successfully
used for novel indications including access and drainage of the gallbladder and an
intrathoracic fluid collection (21) (22) (23). The AXIOS™ stent is FDA approved for the
indication of draining walled off pancreatic necrosis.

The present study aims to compare the clinical efficacy and cost effectiveness of the AXIOS™
stent versus the "conventional" approach using double pigtail plastic stents in the treatment
of patients with walled-off pancreatic necrosis.

Inclusion Criteria:

1. Male or female between 18-80 years old (including patients aged 18 and 80)

2. Subjects capable of giving informed consent

3. Patients carrying the diagnosis or symptomatic sterile or infected walled-off
pancreatic necrosis (WOPN) based upon Atlanta Classification (4) ≥ 4cm in largest
diameter, deemed to require and amenable to endoscopic transmural drainage with or
without necrosectomy by attending gastroenterologist

4. Fluid collection size ≥ 4cm in largest diameter (based on CT, MRI, transabdominal or
endoscopic ultrasound within 30days)

5. Fluid collection that is adherent to the stomach/bowel wall allowing for fistula tract
creation

6. Fluid collection containing significant amount of necrotic material (defined as >30%
of echogenic material by ultrasound/EUS, or necrotic debris by CT/MRI)

Exclusion Criteria:

1. Inability to provide written informed consent

2. Contraindications to endoscopic treatment as determined by the gastroenterologist
attending

3. Pregnant or nursing mothers

4. Bleeding or coagulation disorder

5. Previous surgical or endoscopic cystogastrostomy/enterostomy or necrosectomy

6. Shock

7. Cystic neoplasms or pancreatic malignancy

8. Pseudocysts

9. Subjects cannot be homeless or incarcerated

10. Age younger than 18 or older than 80

11. More than one pancreatic/peri-pancreatic fluid collection
We found this trial at
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Phone: 603-650-5261
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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