Pancreatic Duct Stent for Acute Necrotizing Pancreatitis

AdventHealth

Status: Completed

Conditions: Walled Off Necrosis; Necrotizing Pancreatitis

Treatments: Other: No Pancreatic Duct Stent Placement; Device: Pancreatic Duct Stent Placement

Study type: Interventional

Funder types: Other

Identifiers

NCT03115918

922733

Details and patient eligibility

About

The research design is a randomized prospective clinical study comparing the incidence of Walled Off Necrosis (WON) in patients with acute necrotizing pancreatitis.

Full description

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.

Enrollment: 1 patient

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1 participants in 2 patient groups

Pancreatic Duct Stent Placement

Active Comparator group

Description:

Subject will have placement of either the Advanix or Cook Pancreatic Stent placed.

Treatment:

Device: Pancreatic Duct Stent Placement

No Pancreatic Duct Stent Placement

Active Comparator group

Description:

Subject will not have a pancreatic Duct stent placed.

Treatment:

Other: No Pancreatic Duct Stent Placement