Clinical trial NCT05473260: Home Monitoring Vs. Hospitalization for Mild Acute Pancreatitis
Official title: Home Monitoring Vs. Hospitalization for Mild Acute Pancreatitis. A Pilot Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Pancreatitis
Keywords: acute pancreatitis
mild pancreatitis
outpatient protocol
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: 7-day (after randomization) treatment failure rate
timeFrame: 7 days
Secondary outcomes:
measure: Cumulative incidence of complications secondary to acute pancreatitis during the first 30 days after diagnosis
timeFrame: 30 days
measure: Hospital readmission during the first 30 days after diagnosis
timeFrame: 30 days
measure: Cumulative incidence of mortality during the first 30 days after diagnosis
timeFrame: 30 days
measure: Estimated costs of each intervention
timeFrame: 7 days
measure: Median (95%CI) Charlson Comorbidity Score per group
timeFrame: 7 days
measure: Median (95%CI) EuroQoL 5 Dimensions Quality of Life Score
timeFrame: 7 days
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
References: