PERT in Acute Necrotizing Pancreatitis (NCT07211568) | Clinical Trial Compass
Not Yet RecruitingPhase 3
PERT in Acute Necrotizing Pancreatitis
188 participantsStarted 2025-10-01
Plain-language summary
In this multicenter, double blinded, placebo-controlled, 1:1 parallel group RCT, we propose to evaluate the impact of pancreatic exocrine replacement therapy on patients with acute necrotizing pancreatitis (ANP). We will include patients of 18-60yrs age and both genders with \>50% pancreatic parenchymal necrosis and \>10% loss of body weight.
The primary outcome measure is change in BMI at 3 months after enrolment. The intervention will include pancreatic enzyme consisting of 25000 IU of lipase and similar appearing placebo.
Who can participate
Age range
18 Years – 60 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:
* Patients diagnosed with AP according to the Revised Atlanta Classification diagnostic criteria
* Index episode of acute pancreatitis with at least 50% pancreatic parenchymal necrosis and greater than at least 10% loss of pre pancreatitis body weight at the time of screening
* Within 28 days of onset of disease
* Age 18-60 years
* Both genders
Exclusion Criteria:
* Underlying chronic pancreatitis
* Recurrent acute pancreatitis
* Pancreatic cancer
* Patients being discharged with NJ tubes
* Pregnancy and lactation
* Inability to give informed consent.
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.