Pancreatic Duct Stent for Acute Necrotizing Pancreatitis

Not Applicable

Completed

• Conditions: Walled Off Necrosis; Necrotizing Pancreatitis
• Interventions: Device: Pancreatic Duct Stent Placement; Other: No Pancreatic Duct Stent Placement

• Registration Number: NCT03115918
• Lead Sponsor: AdventHealth

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.

Study Timeline

• Study Start: 2016-08-04
• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-14
• Primary Completion: 2020-07
• Study Completion: 2020-11-03
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pancreatic Duct Stent Placement	Pancreatic Duct Stent Placement	Subject will have placement of either the Advanix or Cook Pancreatic Stent placed.
No Pancreatic Duct Stent Placement	No Pancreatic Duct Stent Placement	Subject will not have a pancreatic Duct stent placed.

Primary Outcome Measures

Name	Time	Method
Incidence of WON between the PD stent and no PD stent groups	4-6 weeks post-index ERCP	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Center for Interventional Endoscopy - Florida Hospital; 🇺🇸 Orlando, Florida, United States