A Trial of Early Percutaneous Catheter Drainage of Sterile Pancreatic Fluid Collections in Severe… (NCT03185806) | Clinical Trial Compass
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A Trial of Early Percutaneous Catheter Drainage of Sterile Pancreatic Fluid Collections in Severe Acute Pancreatitis
China100 participantsStarted 2017-10-06
Plain-language summary
The acute peripancreatic fluid collections (AFPCs) is the most common complication in severe acute pancreatitis (SAP). There are controversies on optimal timing for drainage of APFCs in SAP. The early-stage percutaneous catheter drainage (PCD) of sterile peripancreatic fluid collections is questioned as a result of the major cause of secondary infection. The aim of the present randomized controlled trial is to compare the outcomes in terms of mortality, secondary infection of peripancreatic collections, organ failure, length of hospital/ICU stay and inflammatory biomarkers between the early-stage PCD of sterile AFPCs and conservative therapy.
Who can participate
Age range
18 Years – 70 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 of 18 years to 70 years; and
. Pain characteristic of pancreatitis; and
. Elevated serum lipase or amylase (≥3-fold upper normal range); and
. Persistent organ failure \>48 hours; and
. Organ dysfunction occurred within 7 days after onset of pain; and
. Presentation with a width of ≥2cm of APFCs in the peripheral tissues of the pancreas, the cyst of lesser omentum , or the paracolic sulci on CT image.
Exclusion criteria
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
Mortality
Timeframe: From date of admisstion until the date of in-hospital death or death within two weeks after discharging, whichever came first, assessed up to 1 year.
Trial details
NCT IDNCT03185806
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University