CompletedNot Applicable

Pancreatic Duct Stent for Acute Necrotizing Pancreatitis

United States1 participantsStarted 2016-08-04

Plain-language summary

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

Who can participate

Age range19 Years

SexALL

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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

What they're measuring

Incidence of WON between the PD stent and no PD stent groups

Timeframe: 4-6 weeks post-index ERCP

Trial details

NCT IDNCT03115918

SponsorAdventHealth

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07

View on ClinicalTrials.gov More Necrotizing Pancreatitis trials