Pancreatic Duct Stent for Acute Necrotizing Pancreatitis

This is a randomized trial comparing the incidence of WON in patients with acute necrotizing
pancreatitis, according to the placement or non-placement of an Advanix or a Cook Pancreatic
Duct (PD) stent during Endoscopic Retrograde Cholangiopancreatography (ERCP) within 1-2 week
of symptom onset. Patients will be randomly allocated to either treatment arm i.e. to either
PD stent placement or no PD placement in a 1:1 ratio. The type of stent to be placed is at
the discretion of the physician based on the clinical needs and presentation of the patient
at the time of procedure. This is based on factors such as the size of the WON, the patient's
anatomy, and other variables. Patients will be assessed at 4-6 weeks post-ERCP for the
primary outcome measure, which is the incidence of WON on contrast-enhanced CT.

Inclusion Criteria:

1. Age ≥ 19 years

2. The subject (or when applicable the subject's LAR) is capable of understanding and
complying with protocol requirements.

3. The subject (or when applicable the subject's LAR) is able to understand and willing
to sign an informed consent form prior to the initiation of any study procedures.

4. All patients with acute necrotizing pancreatitis and bedside index for severity in
acute pancreatitis (BISAP) score of ≥ 3, who have been referred to Florida Hospital
for Percutaneous endoscopy gastrojeunostomy (PEG-J) tube placement and/or ERCP for
assessment of the PD

5. Absence of pancreatic fluid collection (defined as those > 3cm in size located along
the course of the main PD on cross-sectional imaging) at the time of study enrollment

6. No disconnected pancreatic duct syndrome (DPDS) on cross-sectional imaging or ERCP

Exclusion Criteria:

1. Age <19 years

2. Unable to obtain consent for the procedure from either the patient or LAR

3. Patients with acute interstitial pancreatitis, without pancreatic necrosis

4. Patients with BISAP score ≤ 2

5. Patients with pancreatic fluid collection > 3cm in size located along the course of
the main PD on cross-sectional imaging prior to the initial ERCP

6. Patients with DPDS on cross-sectional imaging or ERCP

7. Unable to safely undergo ERCP for any reason

8. Failed cannulation during ERCP