Acute Pancreatitis
Conditions
Keywords
acute pancreatitis, mild pancreatitis, outpatient protocol
Brief summary
Acute pancreatitis accounts for a large number of hospital admissions every year. Some studies have shown that early oral feeding protocols are safe, and one previous study suggests the possibility of home care for mild acute pancreatitis.
Detailed description
Approximately 80% of all cases of acute pancreatitis are mild and only require supportive care for pain and nausea control and an adequate fluid replacement. Currently, all patients in our setting diagnosed with mild acute pancreatitis are admitted to a conventional hospitalization ward under the supervision of the Digestive and General Surgery Department or the Gastroenterology Department. Symptomatic treatment is administered, and abdominal ultrasound is performed to assess the cause of pancreatic inflammation. The remaining 20% fulfill the severity criteria from its onset onwards and require intensive care support. We will conduct a multicenter randomized controlled clinical trial to compare two different approaches to mild non-alcoholic acute pancreatitis: hospital admission and outpatient management.
Interventions
OTHERControl
In-patient care.
OTHERExperimental
Early discharge and outpatient follow-up.
Sponsors
Hospital Universitari de Bellvitge
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-day (after randomization) treatment failure rate | 7 days | Treatment failure is defined as a VAS \>3 and/or oral feeding intolerance (nausea, repeated vomiting episodes, early satiety). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital readmission during the first 30 days after diagnosis | 30 days | Number of patients readmitted to the hospital during the first 30 days after diagnosis. |
| Cumulative incidence of mortality during the first 30 days after diagnosis | 30 days | 30-day mortality |
| Cumulative incidence of complications secondary to acute pancreatitis during the first 30 days after diagnosis | 30 days | Complications include, but are not limited to, abscess formation, pseudocysts, local necrosis, kidney failure, respiratory failure. |
| Median (95%CI) Charlson Comorbidity Score per group | 7 days | — |
| Median (95%CI) EuroQoL 5 Dimensions Quality of Life Score | 7 days | — |
| Estimated costs of each intervention | 7 days | — |
Countries
Spain
Contacts
Primary ContactJuli Busquets, PhD
Outcome results
None listed