Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT05473260
Eligibility Criteria:
INCLUSION CRITERIA
Patients diagnosed with mild acute pancreatitis based on at least two of the three following criteria:
* Abdominal pain
* Amylase or lipase 3x ULN (in blood/urine)
* Imaging tests (Ultrasound/CT scan) suggestive of acute pancreatitis.
Age ≥18 years and \<80 years
Absence of potential pancreatitis-related severity criteria:
* No evidence of SIRS in the emergency room
* C-Reactive Protein levels \<150mg/dL
* Marked increase in the White Blood Cell Count
* Absence of coagulopathy (INR \<1.4)
* Hematocrit \< 44%
* Creatinine \< 170 µmol/L
* BISAP score ≤2 at the time of randomization.
Patients with good pain response to 12-hour supportive care in the ER (VAS \<4) or adequate oral feeding tolerability.
Absence of local or systemic complications of acute pancreatitis on imaging tests.
Adequate cognitive capacity and without any previous diagnose of psychiatric disease.
Patients who meet each participating hospital home care criteria. Patients who give their written informed consent to participate.
EXCLUSION CRITERIA
Past medical history of pancreatic disease:
* Known or newly diagnosed chronic pancreatitis (Wirsung dilation or pancreatic calcifications in previous imaging tests)
* Patients with recurrent acute pancreatitis (\>3 episodes/year) or an episode of acute pancreatitis \<1 month ago.
* Acute pancreatitis after endoscopic retrograde cholangiography.
* Hyperbilirubinemia \>3x ULN
Comorbidities that required previous hospitalization (myocardial infarction, liver cirrhosis, chronic kidney disease, or chronic lung disease).
BMI ≥35 Kg/m2 Patients who refuse to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05473260
Study Brief:
Protocol Section:
NCT05473260