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 range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of WON between the PD stent and no PD stent groups
. 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