A Trial of Early Percutaneous Catheter Drainage of Sterile Pancreatic Fluid Collections in Severe… (NCT03185806) | Clinical Trial Compass
UnknownNot Applicable
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 range18 Years – 70 Years
SexALL
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
✕. History diseases of chronic organ dysfunction; or
✕. Traumatic pancreatitis; or
✕. Post-endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis; or
✕. Severe coagulopathy (INR\>2); or
✕
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