Pancreatic Duct Stent for Acute Necrotizing Pancreatitis

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

Detailed 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.

Official Title
-----------------
Randomized Trial Examining the Impact of Pancreatic Duct Stent Placement in Patients With Acute Necrotizing Pancreatitis in the Prevention of Walled-off Necrosis

Conditions
-----------------
Necrotizing Pancreatitis, Walled Off Necrosis

Intervention / Treatment
-----------------
* Device: Pancreatic Duct Stent Placement
* Other: No Pancreatic Duct Stent Placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 19 years The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements. 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. 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 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 No disconnected pancreatic duct syndrome (DPDS) on cross-sectional imaging or ERCP Exclusion Criteria: Age <19 years Unable to obtain consent for the procedure from either the patient or LAR Patients with acute interstitial pancreatitis, without pancreatic necrosis Patients with BISAP score ≤ 2 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 Patients with DPDS on cross-sectional imaging or ERCP Unable to safely undergo ERCP for any reason Failed cannulation during ERCP

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pancreatic Duct Stent Placement<br>Subject will have placement of either the Advanix or Cook Pancreatic Stent placed. | Device: Pancreatic Duct Stent Placement<br>* Patients will be randomly allocated to either treatment arm to have a PD stent placed.<br>|
| Active Comparator: No Pancreatic Duct Stent Placement<br>Subject will not have a pancreatic Duct stent placed. | Other: No Pancreatic Duct Stent Placement<br>* Patients will be randomly allocated to either treatment arm and not receive PD placement.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of WON between the PD stent and no PD stent groups | The primary aim of the study is to compare the incidence of WON between the PD stent and no PD stent groups at 4-6 weeks post-index ERCP. | 4-6 weeks post-index ERCP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of WON Intervention | Incidence of WON requiring intervention of any type (including endoscopic, surgical or interventional radiology interventions) | 6 weeks | 
| Rates of DPDS | Incidence of DPDS, as determined by ERCP or Magnetic Resonance Cholangiopancreatography (MRCP) | 6 weeks | 
| Number of patients with Adverse events | Incidence of procedure related adverse events | 6 weeks | 
| Rates of additional interventions resulting from complications | Incidence of other interventions undertaken as clinically indicated for complications of acute pancreatitis | 6 weeks | 
| Number of patients with Acute pancreatitis | Clinical adverse events related to underlying acute pancreatitis | 6 weeks | 
| Number of patients with Local complications | Clinical adverse events arising as a result of local complications of acute pancreatitis | 6 weeks | 
| Number of patients with Systemic complications | Clinical adverse events arising as a result of systemic complications of acute pancreatitis | 6 weeks | 
| Length of stay | Duration of hospitalization in days | 6 weeks | 
| Cost | Total hospital costs in US Dollars | 6 weeks |