Comparing home monitoring to hospitalization for mild acute pancreatitis

Home Monitoring Vs. Hospitalization for Mild Acute Pancreatitis. A Pilot Randomized Controlled Clinical Trial

This study is testing if managing mild acute pancreatitis at home is just as effective as being hospitalized for patients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 308 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Hospital Universitari de Bellvitge (other)
• Locations: 1 site (L'Hospitalet De Llobregat, Barcelona)
• Trial ID: NCT05473260 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of home monitoring versus traditional hospitalization for patients with mild acute pancreatitis. It will involve a multicenter randomized controlled design, where participants will be assigned to either an outpatient management protocol or a conventional hospital admission. The study will assess patient outcomes, including pain management and recovery, while ensuring safety through regular monitoring. The goal is to determine if home care can be a viable alternative for managing mild cases of this condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 diagnosed with mild acute pancreatitis who meet specific clinical criteria and have no severe complications.

Not a fit: Patients with severe acute pancreatitis or those requiring intensive care support will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce hospital admissions and healthcare costs while providing effective care for patients with mild acute pancreatitis.

How similar studies have performed: Previous studies have suggested the feasibility of outpatient management for mild acute pancreatitis, indicating potential success for this approach.

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.

Where this trial is running

L'Hospitalet De Llobregat, Barcelona

• Hospital Universitari de Bellvitge — L'Hospitalet De Llobregat, Barcelona, Spain (RECRUITING)

Study contacts

• Study coordinator: Juli Busquets, PhD

Conditions: Acute Pancreatitis, acute pancreatitis, mild pancreatitis, outpatient protocol