Pancreatic Duct Stent for Acute Necrotizing Pancreatitis

Completed · Not applicable

Conditions studied: Necrotizing Pancreatitis, Walled Off Necrosis

In brief

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

Key facts

Study ID

NCT03115918

Run by

AdventHealth

People needed

1

Starts

2016-08-04

Expected to finish

2020-11-03

Last updated by the study team

2022-02-17

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Center for Interventional Endoscopy - Florida Hospital — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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